GCP-Service West under Regulatory Review by Cologne and Düsseldorf Authorities
GCP-Service West under Regulatory Review by Cologne and Düsseldorf Authorities
Between 20 and 22 August 2025, the local competent authorities of Cologne and Düsseldorf will conduct a formal GCP inspection. This inspection will focus on two clinical trials under the legal sponsorship of GCP-Service International West GmbH (GCPS West): the PATROL and REMARK studies. Join our journey and learn with us!
Regulatory inspections of this kind are a core element of clinical trial oversight in the European Union. They are intended to ensure that trials are conducted in accordance with Good Clinical Practice (GCP), that patient rights and safety are protected, and that data integrity is preserved. For GCP-Service, this is not just an obligation, but an opportunity to demonstrate our commitment to excellence, transparency, and support of innovative research, especially in the context of Sponsorship-as-a-Service (SPaaS).
Between 20 and 22 August 2025, the local competent authorities of Cologne and Düsseldorf will conduct a formal GCP inspection. This inspection will focus on two clinical trials under the legal sponsorship of GCP-Service International West GmbH (GCPS West): the PATROL and REMARK studies. Join our journey and learn with us!
Regulatory inspections of this kind are a core element of clinical trial oversight in the European Union. They are intended to ensure that trials are conducted in accordance with Good Clinical Practice (GCP), that patient rights and safety are protected, and that data integrity is preserved. For GCP-Service, this is not just an obligation, but an opportunity to demonstrate our commitment to excellence, transparency, and support of innovative research, especially in the context of Sponsorship-as-a-Service (SPaaS).
At the center of this inspection is the legal Sponsor-CRO model, as defined under the EU Clinical Trial Regulation (CTR) and GCP guidelines. In this case, the sponsor is GCP-Service International West GmbH, a subsidiary entity specifically tasked with holding sponsor responsibility for a selected portfolio of trials. The sponsor’s official contact is Andreas Beust, who represents GCPS West in regulatory and contractual matters.
All operational trial services have been delegated to GCP-Service International Ltd. & Co KG, our headquarter CRO entity, based in the European Union. This full-service CRO is represented by Thomas Kissner (for the PATROL and REMARK study), and delivers all trial management activities on behalf of the sponsor, including:
Clinical operations and monitoring
Project and vendor management
Data management and electronic systems (EDC, CTMS, eTMF/eISF)
Regulatory submissions and site contracting
Biostatistics and medical writing
Document and Trial Master File (TMF) management
Pharmacovigilance and medical monitoring
Auditing and quality assurance
Clinical operations and monitoring
Project and vendor management
Data management and electronic systems (EDC, CTMS, eTMF/eISF)
Regulatory submissions and site contracting
Biostatistics and medical writing
Document and Trial Master File (TMF) management
Pharmacovigilance and medical monitoring
Auditing and quality assurance
The model is designed to ensure that sponsor oversight and regulatory responsibility remain clearly defined, while trial execution is conducted by a highly experienced and integrated CRO team. This separation of roles is aligned with regulatory expectations and ensures transparency in accountability and quality control.
The REMARK and PATROL trials are investigator-initiated trials (IITs) conducted under the academic leadership of the EMSCO network, with Prof. Platzbecker as principal investigator. GCPS West acts as the legal sponsor, enabling academic researchers to conduct regulatory-compliant research while maintaining scientific independence.
The PATROL trial is an exploratory Phase II study focusing on patients with higher-risk chronic myelomonocytic leukemia (CMML), a complex blood cancer that typically affects older adults and has limited treatment options.
PATROL is evaluating a three-drug combination therapy involving:
a standard-of-care hypomethylating agent
a BCL-2 inhibitor
a targeted therapy authorized in other hematologic conditions
a standard-of-care hypomethylating agent
a BCL-2 inhibitor
a targeted therapy authorized in other hematologic conditions
The primary aim is to generate data on clinical response rates (CR, mCR, PR) after three treatment cycles, using both descriptive and statistical methods. Secondary objectives include safety and tolerability, overall survival, transfusion independence, hematologic improvement, and patient-reported quality of life outcomes.
PATROL is currently recruiting patients in Germany, Italy, and Spain. It was authorized in early 2025, with first-patient-in dates between May and June. The study is sponsored by GCPS West and supported by Stemline Therapeutics and AbbVie Inc., who supply the investigational products. The study is expected to run until late 2029, providing long-term outcome data in a difficult-to-treat population.
The REMARK trial is a multicenter, open-label Phase II study focusing on patients with lower-risk myelodysplastic neoplasms (MDS), a group of chronic bone marrow disorders that often lead to anemia and reduced quality of life. Lower-risk MDS affects a significant proportion of elderly patients and is typically managed with supportive care. However, many patients develop resistance or intolerance to standard therapies, highlighting the need for novel treatment options.
REMARK is evaluating the clinical potential of a new oral investigational therapy:
RVU120, an oral CDK8/CDK19 kinase inhibitor with epigenetic activity designed to promote erythropoiesis and improve hemoglobin levels in MDS-related anemia
The primary objective of the study is to assess erythroid response (HI-E) according to the International Working Group (IWG) 2018 criteria after eight cycles of treatment at a daily dose of 150 mg. Patients who discontinue prematurely or cannot be evaluated are considered non-responders, ensuring a conservative and meaningful assessment of efficacy.
Secondary objectives include additional markers of hematologic improvement, safety and tolerability, and the broader therapeutic potential of RVU120 in a patient population with few alternatives. The trial is scoped for both safety and efficacy evaluation.
This is a general inspection, but for the scope of execution they also look at studies. The authorities will review key areas such as:
Sponsor responsibilities and the delegation of trial tasks
Quality management systems, including SOPs and QA oversight
Cooperation agreements between sponsor and other involved entities
Computer-based systems used in trial conduct (EDC, TMF, safety databases)
Trial Master File (TMF) management and documentation
Monitoring activities, both onsite and remote
Investigational Medicinal Product (IMP) handling and tracking
Pharmacovigilance systems and safety reporting processes
Preparation began immediately after the announcement on 10 July 2025, with coordination led by Petra Štěpánková (Head of Quality Assurance) and Friederike von Möller (Quality Assurance Manager). Content will continue to be published throughout the preparation phase, including:
GCP inspections are often seen as closed-door events, but they don’t have to be. By documenting our experience, we aim to:
GCP inspections are often seen as closed-door events, but they don’t have to be. By documenting our experience, we aim to:
At GCP-Service, we strive to make clinical trials accessible, and this campaign is part of our commitment to transparency, education, and continuous improvement.
The world of clinical research is constantly evolving, with new regulations and increased scrutiny shaping how trials are conducted. At GCP-Service, we’re not just observing these changes; we’re actively navigating them, taking on new roles and responsibilities to support the advancement of vital research.
In an exciting and significant development, our GCP-Service International West office is preparing for an upcoming clinical inspection by a German federal agency. This isn’t just any inspection; for the first time, the focus is squarely on our role as a Sponsor of clinical trials—a unique and thrilling challenge that offers unparalleled learning opportunities.
In this in-depth post, we sit down with Andreas Beust, Sponsor Representative and Managing Director of GCP-Service West, to dive into what this inspection entails. You’ll learn:
Join us as we embark on “The Road to a Successful Inspection”, sharing our experiences and insights to benefit everyone involved in clinical research. We believe transparency and shared knowledge are key to advancing clinical trials effectively and responsibly in Europe.
What’s Being Inspected and Why It Matters
As part of our series ‘The Road to a Successful Inspection’, we sat down with Andreas Beust, Sponsor Representative and Managing Director of GCP-Service West, to talk about the upcoming inspection. What’s being reviewed, why it matters, and what makes this inspection special for us? Let’s dive in.
A clinical inspection occurs when a governmental agency reviews a specific clinical project or your system for running projects overall. In Germany, this is a federated system, and here we have a federal agency that visits you. These are experienced people who know a lot about the regulations and requirements of clinical research. They investigate whether everything you’re doing within that sphere, within clinical research, is according to regulatory requirements, with a very clear focus on patient safety, patient rights, and data integrity. They are mandated to do that, as the state of Germany has an interest that the given rules are being followed. So, at normal intervals, or upon any observed incidences, they have a right to say, “We would like to visit you, and we’re coming by in a few weeks. Make sure that you’re available, and please share with us all information that we need to actually know to have confidence that you’re working according to the requirements.”
We are inspected by the federal agency located in Cologne and Dusseldorf. These two cities are close to one another in the West of Germany. They visit us because our office, GCP Service International West, situated in Siegburg, falls within the scope of this inspection. Siegburg is very close to their location. In Germany, the agencies inspecting companies must be regionally associated. Our office is near this inspectorate, so they come over to inspect us. If our headquarter entity is the focus of an inspection, then the inspectorate from Bremen visits us. In this specific case, it’s the one from Cologne and Dusseldorf. They conduct these inspections at frequent intervals because we have ongoing projects. They are informed about these projects because they are publicly registered, making them aware that we are performing these studies. Therefore, it’s a good time for them to check in and see how we are doing and whether everything is running according to requirements.
This is the really exciting part for me personally. Usually, we’re in the scope as contract research organization (CRO), meaning we receive a very systematic review of what we do and how we execute projects on behalf of trial Sponsors. This time, the focus is different because we are acting as Sponsor of these trials. This is exactly how a small biotech company, a large pharmaceutical company, a medical device manufacturer, or a university clinic running an investigator-initiated trial would be scrutinized if they were the sponsor of their project. This gives us an opportunity to gain insights and have valuable discussions about how we’ve set up our sponsorship-as-a-service program and how to act as a sponsor in clinical trials. That’s why we wanted to share it.
Over the last five years, primarily from 2020 onwards, there have been massive changes to the clinical trial landscape in Europe. We’ve seen complete shifts in our regulatory framework. European-level directives for medical devices, in vitro diagnostics, and drugs have all transitioned into regulations on a European level: the Clinical Trial Regulation, Medical Device Regulation, and IVD Regulation. This significantly shifted the regulatory landscape.
On top of that, we’ve had updates to ISO 14155 and ICH-GCP, along with many additional provisions following and during the COVID pandemic. For many smaller companies, especially, this massive change means a lot has to change, leading to increased uncertainty and scrutiny. As a result, we’ve seen a dwindle in the readiness and willingness to take on the responsibility of study sponsor.
While many industry-sponsored clinical trials continue to run, a large portion are still conducted under the “investigator-initiated trial” umbrella. This isn’t a strict regulatory term, but it refers to university clinics taking on the responsibility of initiating a trial, often with a more academically driven focus. Here, the level of professionalism seen in large corporations isn’t always present.
Suddenly, with all these changes, the risk increases regarding whether everything is truly considered and implemented, and if adherence is possible. You don’t want to face an inspection and uncertainty about passing, or as a university clinic, be prohibited from participating in trials. This can become a significant hurdle, especially in multinational trials where regulations may differ slightly between countries. We’ve seen this deeply impact society and our ability to conduct fundamental research in Europe.
Therefore, we wanted to do something about it. We now offer the opportunity for us to take on that sponsorship responsibility. This allows our partners—in this case, our academic partners at universities for these two studies currently in focus—to concentrate on the science behind the project, while we handle the logistics and regulatory aspects.
For this inspection, the inspector informed us that two of our trials, which we run as a sponsor, are in focus: the REMARK project and the PATROL project. Both are conducted in collaboration with the EMSCO Network, a European network focusing on Myelodysplastic Syndromes (MDS) as a disease indication.
Within that space, we are running these two projects. The REMARK project involves patients with lower-risk MDS, while the PATROL project focuses on patients suffering from Chronic Myelomonocytic Leukemia (CMML). Both projects are multi-country European studies, always involving Germany, but also extending from Southern to Eastern European countries.
Our REMARK project has already completed all patient enrollment. We are currently in the active treatment phase for all patients, with some already in follow-up. For the PATROL study, we are about to begin treatment for the first patients.
The inspection will generally focus on high-level topics, such as how we, as a sponsor, ensure we have oversight over the trial. They will assess our adherence to regulatory requirements and whether we have contracts in place with all involved parties.
Beyond that, they will delve into more study-specific tasks: how we handle pharmacovigilance, document management, and investigational medicinal product (IMP) logistics for these projects, along with tracking compliance. This involves a mix of reviewing our quality management system and how we manage our role as the sponsor within the trial, including contractual relationships with different parties. They will also examine the study-specific execution of our agreements and their adherence to general regulatory requirements. I would say this scope is rather typical for an inspection.
Preparing for the Inspection
The upcoming inspection is scheduled for August 20th through August 22nd, involving three days with three inspectors. Inspections are typically held at the sponsor’s premises, but our office there is smaller. It’s highly recommended and often required to have two separate rooms: one for general discussions and another where inspectors can review documents and confer privately. As our current office in Siegburg doesn’t offer this ideal setup, we’ve rented meeting rooms to host the inspectors, ensuring a convenient and uninterrupted environment for the three days with the necessary logistical support.
Initial Steps and Communication
Our preparation began immediately upon receiving the inspection letter. Coincidentally, the news broke during a meeting with all our team leads, so awareness spread rapidly. We held an initial meeting the same day to organize everything, confirm availability, and clarify any immediate questions. The first crucial step was to acknowledge the inspection and understand its requirements.
My first action was to call the inspectors directly. I wanted to clarify the relationship between us as a sponsor and GCP Service’s headquarters as a Contract Research Organization (CRO). It was important to ensure they understood they were inspecting the sponsor oversight piece of the trial, not a company performing end-to-end work for the trial, as other aspects are outsourced to a different entity outside their jurisdiction. They briefly clarified this, and it was accepted. We also discussed hosting them in Cologne, Siegburg, or Bremen, but they confirmed they could only conduct the meeting within their jurisdiction.
Ongoing Preparations and Timeline
Beyond that, most requirements were already provided in writing. By day two, we had internal alignments across the team. We acknowledged that it’s mid-summer, meaning some key project leads are on vacation during the inspection, but this is manageable. We established a timeline to manage all tasks until the document submission deadline, which is July 30th or 31st. At this point, we will upload a substantial number of documents for their review prior to the on-site discussions in late August.
Internally, our quality assurance team now conducts check-ins once or twice a week to navigate the entire preparation process, including internal reviews and managing communication among our participants. They ensure all necessary documents are compiled for submission and confirm everything is progressing as planned.
Looking ahead to August, we plan to conduct an internal mock inspection around August 13th. This will allow us to practice our presentation, establish a clear structure, and identify any potential gaps that need further explanation or supporting documentation. Having everything ready will enable us to quickly answer any questions that arise.
We plan to arrive in Cologne on August 19th, ensuring we are ready for the morning of the 20th. From then on, our focus will be on addressing the inspectors’ questions and discussions. We will have presentations prepared and will respond to whatever comes up.
Sharing Our Journey: An Opportunity for the Clinical Research Community
At GCP-Service, we’re passionate about sharing knowledge. Through our GCP Mindset channel, we aim to engage people in clinical research. We’re actively involved in teaching students and offering internships, among other initiatives. For me, a significant opportunity in leading this company is to make clinical research simpler for all parties involved – that’s what I want to achieve with GCP-Service.
Receiving this inspection letter and realizing that this time, I wouldn’t be sharing information for another contract research organization – who are all professionals for whom this is a daily routine – was exciting. Instead, the focus of this inspection, and our readiness for it, resonates more with how a BioTech, MedTech company, or academic sponsor might perceive being inspected. They often only have oversight over the core of the clinical trial, with everything else outsourced.
This different scope genuinely excited me because it aligns much more with the type of people we want to help. While thinking about “what if things go wrong” can be daunting, it’s part of real life. I believe we have an excellent approach to managing trials as a sponsor; I wouldn’t do it otherwise. Any challenges that arise can become valuable lessons. If, and when, we pass this inspection, we can share our methods, instilling confidence in others that they too can run trials this way. This ultimately benefits everyone, as it will lead to more trials being conducted adequately in Europe. For me, that’s a truly positive outcome, and an opportunity we cannot let pass.
An Exciting Opportunity for Growth and Learning
I’m genuinely excited about this. I love it. While it might be a bit more stressful for the team than for me, I understand the high stakes. For three days, I’ll be representing the trial as the sponsor. However, I already have weekly meetings with the teams, review our systems, and receive reports, so I know these studies very well. While not to the same depth as the project managers- nor is that my role – it’s a fantastic opportunity to learn.
I’m a strong advocate for growth, development, and receiving feedback. This inspection offers an excellent chance for external experts to review our processes and provide impactful feedback on our operations. I always enjoy audits and inspections we participate in, but those focus on our role as a contract research organization. I love that we offer sponsorship as a service and the positive impact we can have with it, so getting feedback on this specific area is simply invaluable.
At every conference, I seek out opportunities to speak with inspectors to gain their perspective on clinical trial regulations, guideline interpretations, and observed issues. Now, I’ll have three days with three of them! A perfect opportunity, which is like gold to me. It would be a waste not to share this experience. I’m very happy to dedicate time to structure what we do and what we learn, so that others can benefit from it as well. Such an opportunity brings me immense joy.
We’re Here to Help: Your Questions Drive Our Content
I hope you’ll find the information we compile enjoyable and helpful. Please, don’t hesitate to ask questions. Over the coming weeks, we’ll strive to structure our content clearly, aiming for transparency regarding our processes and outcomes. Our goal is to create something truly helpful and actionable for you.
If anything remains unclear or if you require further guidance, please reach out. Whether through comments, messages, or direct contact, there are many ways to connect with us or interact with our content. This allows us to refine our offerings and deliver even greater value to you. I’m keen to maximize this opportunity in the coming weeks and months. So, if you have any questions or concerns, just reach out.
This inspection is a big deal, and here’s why it’s personally exciting for us. Normally, we at GCP Service act as a Contract Research Organization (CRO). A CRO is the team that handles all the day-to-day work of a clinical trial for someone else, the “sponsor.” We’re used to getting inspected on how well we do that job – things like managing data, monitoring sites, and handling documents for our clients.
But this time, it’s totally different. In this inspection, GCP Service International West is actually acting as the Sponsor for these trials. The Sponsor is the one ultimately responsible for the entire clinical trial, making sure it’s done safely, ethically, and according to all the rules.
We are the “owner” of the trials for this inspection. Our main job is to have overall oversight – like the conductor of an orchestra. We ensure everything is planned correctly, the right people are in place, and all major risks are managed. We don’t do all the detailed daily tasks ourselves, but we make sure they are being done correctly.
This is our other entity, which we’ve hired to do the actual “playing” of the music. They handle all the operational tasks of the trials, such as running the patient visits, collecting data, managing drug supplies, and so on. We, as the Sponsor, delegate this work to them.
We are the “owner” of the trials for this inspection. Our main job is to have overall oversight – like the conductor of an orchestra. We ensure everything is planned correctly, the right people are in place, and all major risks are managed. We don’t do all the detailed daily tasks ourselves, but we make sure they are being done correctly.
This is our other entity, which we’ve hired to do the actual “playing” of the music. They handle all the operational tasks of the trials, such as running the patient visits, collecting data, managing drug supplies, and so on. We, as the Sponsor, delegate this work to them.
This setup is very common for smaller biotech companies, medical device makers, or even university clinics. They might have a small internal team to be the Sponsor and oversee things, but they outsource almost all the hands-on work to an expert CRO.
So, this inspection gives us a chance to show how our “Sponsorship-as-a-Service” program works in real life. We get to have important talks about how we manage our role as a Sponsor, even when the detailed work is outsourced. That’s why we’re so keen to share this experience with you.
The decision for GCP-Service to assume the sponsor role in specific trials is a direct response to the profound transformation of the European clinical trial landscape since 2020. We’ve seen a complete overhaul of the regulatory framework, with European-level directives transitioning into comprehensive regulations (Clinical Trial Regulation, Medical Device Regulation, IVD Regulation). This, coupled with updates to ISO 14155 and ICH-GCP, has created a significantly more complex and scrutinized environment. This has led to a noticeable decline in the willingness of many, especially smaller companies and academic groups, to take on the demanding responsibilities of a study sponsor. These entities, often driving critical investigator-initiated trials (IITs), may not have the extensive professional infrastructure of large corporations, leading to increased risk regarding compliance. We recognized this as a hurdle impacting fundamental research in Europe.
By offering sponsorship responsibility, we provide a crucial solution. This allows our academic and smaller partners to focus on the scientific breakthroughs of their projects, confident that the intricate logistics and regulatory adherence are managed by us. This model specifically supports vital research that might otherwise be hindered by the escalating regulatory burden.
Preparation for a regulatory inspection is never just a matter of checking boxes. For us it’s a structured, multi-level effort that balances strategic foresight, operational alignment, and regulatory excellence. Take a look behind the scenes of our inspection readiness: how we mobilized our teams, organized our workflows, and stress-tested our systems to ensure a successful outcome.
Immediately after receiving the official inspection announcement on 10 July 2025, we activated a two-tiered response structure. The core inspection team consists of five individuals representing both sponsor and CRO perspectives. Andreas Beust (for GCPS West) and Thomas Kissner (for GCPS HQ) represent sponsor and CRO leadership, respectively. They are supported by three senior members of the Quality Assurance (QA) department, including two native German speakers, as the inspection will be conducted in German, to manage oversight and coordination.
This team’s primary function is organizational: assigning responsibilities, tracking timelines, reviewing document quality, and coordinating all submissions to the inspectors. Without dedicated QA capacity and leadership, such centralized coordination would not be possible.
In parallel, the project teams for the REMARK and PATROL studies were activated. Each is led by the respective Project Manager who liaises closely with QA to ensure all study-specific documents, processes, and presentations are up-to-date, aligned with protocol and SOPs, and accessible for inspection. Though inspection readiness is a continuous goal, we used this opportunity to re-review our project files and reinforce our high internal standards.
To keep all moving parts aligned, we established an evolving communication flow: weekly alignment meetings, dedicated Excel trackers, and shared inspection folders on a secure SharePoint instance. All tasks, especially the provision of requested documents, were assigned early with clear deadlines. As of 31 July, all initially requested documents were uploaded, reviewed, and confirmed via final QA verification.
Spontaneous meetings, subject matter queries, and compliance checks continue to supplement this structure, ensuring no gaps are overlooked. Each document is reviewed not only for completeness, but also for redaction (e.g., financial information in contracts) and traceability.
To keep all moving parts aligned, we established an evolving communication flow: weekly alignment meetings, dedicated Excel trackers, and shared inspection folders on a secure SharePoint instance. All tasks, especially the provision of requested documents, were assigned early with clear deadlines. As of 31 July, all initially requested documents were uploaded, reviewed, and confirmed via final QA verification.
Spontaneous meetings, subject matter queries, and compliance checks continue to supplement this structure, ensuring no gaps are overlooked. Each document is reviewed not only for completeness, but also for redaction (e.g., financial information in contracts) and traceability.
To go beyond administrative readiness, we introduced two types of internal “stress tests”:
As sponsor contact, Andreas is conducting one-on-one interviews with members of key departments involved in trial delivery. The goal is to understand in detail how deviations were handled, what challenges emerged, and what lessons were learned. This provides critical context that may not be visible in standard documentation.
A full simulation with internal QA playing the role of inspectors is scheduled for mid-August. These sessions are designed to pressure-test our preparedness, identify weak points, and allow us to develop proactive corrective actions where needed.
Given that the GCPS West office in Siegburg lacks dedicated meeting space, we’ve secured a nearby external location suitable for a three-day inspection. The setup includes two separate rooms, one for the inspectors and one for the sponsor team, with video call capability, printing facilities, and catering. This logistical foresight ensures a professional and comfortable inspection environment.
Inspection letter received
Core and project teams aligned
Interim status check successful
Documents uploaded to inspectorate
Inspection letter received
Functional interviews and catch-up meetings
Mock inspection
Official inspection
Despite overlapping vacation schedules (a common challenge in summer) the team demonstrated agility, commitment, and clarity of purpose. Post-inspection, we anticipate a 4–6 week period before receiving the draft report. Our internal review and CAPA planning will already be underway by then.
As GCP-Service West prepares for its first regulatory inspection as a clinical trial sponsor, we spoke with Friederike von Moeller, one of the company’s key figures in Quality Assurance. In this in-depth conversation, she explains how the team is preparing, why some requests were expected, and what the inspection focus tells us about future trends in GCP.
No, not really. From my perspective, the list of requested documents was quite typical. It included what we would expect at this stage: the study protocol, information about protocol deviations (PDs), a list of enrolled patients, and other essential elements that help inspectors understand the current status of the studies. There were general questions related to our sponsor responsibilities and also some study-specific requests. It all aligned with the kind of preparation we normally see in an inspection scenario.
Indeed these documents are already accessible to the authorities, as we uploaded them to regulatory systems like CTIS during the approval process. However, it’s often more efficient for inspectors to receive them directly from us in one place. It reduces the time they’d have to spend digging through other systems. Also, it’s a way for us to demonstrate our readiness. When we deliver a clean, complete package of documents, it signals that we’re organized and taking the inspection seriously. That first impression really matters.
Organizational charts are quite helpful in giving inspectors a quick overview of how a company is set up. They want to see which departments exist, which roles exist, and how responsibilities are distributed, especially in a complex setup like ours, where sponsor and CRO activities are split across two entities. It also gives them insight into the scale of the organization, how many people work in which functions and at which level.
It can. In our case, GCP-Service West is the sponsor, and it’s a subsidiary of GCP-Service International, which acts as the CRO. That setup might not be familiar to all inspectors, so we decided to give them a short presentation to explain the structure, even though it wasn’t explicitly requested. This helps them understand who they’re inspecting and how our responsibilities are distributed across entities. It’s not about legal obligations, it’s about clarity and context.
Not necessarily, but it felt right in this case. We wanted to ensure there was no confusion from the start. We’ll still need to explain things in person, of course, but the presentation gives them a head start. It’s better to overcommunicate than leave room for misinterpretation, especially when the structure isn’t standard.
It wasn’t completely unexpected. We’re seeing an increasing focus on computerized systems, especially since the release of ICH GCP E6(R3) and the EMA guideline on this topic. Computerized System Validation (CSV) is becoming a bigger part. The requests are becoming more detailed, and it’s clear that computerized tools and data systems are now seen as central to trial quality, data integrity and oversight.
Yes, that’s very common. The list helps them understand which processes exist in the company. From the titles alone, they can already get a sense of how well-structured things are and what areas might need more attention. In our case, they also requested a selected set of SOPs in advance, and others may be asked for later.
It could. It’s not a typical setup, and that’s why we took the time to explain it. Our sponsor and CRO functions are handled by two different entities, but both follow the same QMS. We’ve documented this and laid it out in the presentation we submitted. Still, we expect questions, and we’ll need to walk them through it.
Protocol deviations are closely linked to two main areas of concern: patient safety and data integrity. Inspectors will look at the PD list to assess how issues were handled, how they were rated, whether CAPAs were implemented, whether those CAPAs were resolved. A well-maintained PD list gives insight into the robustness of the monitoring process. It can also show whether a site or sponsor is being proactive or reactive when deviations occur.
In theory, yes. An inspectee could try to curate the list and exclude certain entries to make things look better. But from an inspector’s perspective, you learn to look for inconsistencies. If the PD list looks too clean, but the TMF or site files tell a different story, then alarm bells ring. Trust is built when the documents show transparency. And frankly, if someone’s trying to hide something, it usually becomes obvious pretty quickly.
Not at all. The process is documented in our monitoring SOPs and supported by a form we use to document green light decisions. We just don’t have a separate SOP with that specific title. As long as the process exists and is traceable, it meets the requirements.
I am feeling good about the inspection preparation so far. We’ve mapped all document requests in an Excel sheet, showing both the requested document and the corresponding one in our system, including comments if names differ or cross-references are needed. That way, everything is traceable. Of course, we’re still waiting for the full inspection agenda, so there may be more requests coming. But overall, yes, I’d say we’re well on track. We’re trying to approach this with openness, ready to learn and improve where needed.
Part six of our “Road to the Inspection” series brings you closer to the team preparing for a critical milestone in our company’s history: our first inspection as a sponsor. We spoke with Gero zur Hellen, Friederike von Moeller, and Annelies Weyn about their roles, backgrounds, and expectations as the big day approaches.
Q: Gero, your path to becoming a QA Manager is quite unique. Can you walk us through how you started in clinical research and how you transitioned into quality assurance?
Yes, it’s definitely not the most traditional route. I started out five years ago as a data manager and never really expected to end up in QA. But over time, especially as a senior data manager, I became more involved in SOPs and quality control. I realized I really enjoy following procedures. but I also like improving them. That includes study protocols, but especially regulatory processes. So now I’ve officially joined the QA team as a QA manager.
Q: And you’re diving straight into your first inspection?
Exactly. It’s my first real inspection, and I’ll be mainly supporting from the background. Given my background in data management and computerized systems validation, I’ll be handling documentation, system lists, and anything the inspectors might ask for related to systems and compliance.
Q: With ICH E6 (R3) now putting more emphasis on computerized systems, do you expect that part of the inspection to be a bigger focus?
Absolutely. We’ve already seen from the document requests that computerized systems are more in focus. It’s hard to say how deep the inspectors will go, it depends on their expertise, but whether they’re specialists or more general, I expect it to be an interesting topic to discuss.
Q: You also act as our Data Protection Officer. Did that experience influence your transition to QA?
Yes, actually more than the data management role did. Dealing with incidents and ensuring a strong quality track record in data protection brought me in regular contact with QA. I got to know the team, how they think, how they work. That laid the foundation. Data management keeps me grounded, but data protection gave me the push toward QA.
Q: What are your expectations for the inspection itself?
I expect it to be exciting. It’s a new experience for me in the sponsor context, and I’m looking forward to seeing how it unfolds. There’s a lot to learn.
Q: Friederike, you’re the designated lead and key contact for the inspectors. Tell us a bit about your journey into clinical research and how you came into this role.
I started as a CRA back in 2012. Later, I joined the QA team, first as an associate and then as a manager. That’s what I do now, supporting the quality aspects across all our processes.
Q: You’ve worked closely with both data management and statistics. Was that part of your role from the beginning?
In the early years, I focused more on CRA and project management processes due to my background. But over time, I got more involved in other areas like data management and biostatistics. That broader view has been helpful.
Q: How are you feeling with just a few weeks left before the inspection?
So far, I feel good. I’m not alone, there’s great support from the QA team, the project staff, and of course, you Andreas and other colleagues. That makes a big difference.
Q: Since the inspection is in German, does that present a challenge, especially with documentation and slides being in English?
It can feel a bit strange switching between languages, but it’s manageable. I’m a native German speaker, and while the materials are in English, the inspectors will likely understand both. It’ll be a mix, but I think we’re well prepared.
Q: Once the inspection is over, what happens next? Time to relax?
Not quite yet. There’s always follow-up work, reviewing findings, documenting responses, and ensuring everything is in place. But yes, hopefully, a few days of rest will be possible.
Q: You’ve participated in inspections before. What’s different now that we’re in the sponsor role?
The approach is a bit different. The setup, the expectations, they’ve shifted slightly. But overall, it still feels familiar. We’re ready.
Q: Annelies, you’ve been a project manager for many years. What’s different now that you’re leading one of the trials under inspection?
This project feels a bit closer to my heart. It’s exciting to be part of something where we can directly apply our flexible and fast solutions. If something doesn’t work, we can change it quickly. The turnaround times are impressive, and working so closely with the team makes it all the more enjoyable.
Q: What’s it like to manage a trial where the sponsor is also internal?
It’s a different kind of trust. Of course, all our sponsors trust us, but when the sponsor is part of the same team, the collaboration is even tighter. We understand each other’s processes very well.
Q: Was there anything in your past experience that especially prepared you for this role?
Yes, but I also had to expand my perspective. As a project manager, you usually focus on operational delivery. But when you’re representing the sponsor, you think more broadly. You consider IMP management, safety aspects, and regulatory oversight, it’s a wider responsibility.
Q: What was your first reaction when you heard your study was selected for inspection?
It was a moment of surprise, “Oh wow, okay, it’s happening.” Sadly, I’ll be on holiday during the inspection, which is disappointing. This project is like my baby, and I’d have loved to be there. But we’ve made sure everything is prepared, and the team will handle it well.
Q: Do you anticipate any surprises during the inspection?
I don’t expect any major issues. If they find something, I’ll be curious to see what it is. We’ve worked hard, and I’m confident. I’m not afraid of minor findings, they’re manageable. I just hope everything goes smoothly.
Final Thoughts
With just days to go, the team behind the inspection preparation at GCP-Service is confident, coordinated, and calm. Whether it’s Gero diving into computerized system validations, Friederike leading communications with inspectors, or Annelies managing a fully enrolled trial, their collaboration and expertise show how much groundwork goes into being inspection-ready.
With one week to go before our on-site inspection (August 20-22, 2025, Cologne), here’s where we stand:
Additional requests: We received further document requests last week, including contracts and clarifications on who is working for GCP-Service West on the inspected trials. As sponsor representative, this is handled by Andreas Beust. The authority also asked a few process-level questions related to the studies in scope.
Expanded inspection team: On Monday, the authority informed us that three additional inspectors will join on site, including two department leads (subject-matter experts) from the German Competent Authority (BfArM). In total, six people will be present over the three inspection days. This raises the bar, but it also offers a chance for deeper, constructive discussions on our projects and processes.
Cross-functional deep dives: We completed working sessions with Data Management and Biostatistics (with a focus on REMARK, which is progressed further) to confirm whether anything deviated from our planned standards. If that was the case, we mapped how and why that was the case. We’ve prepared concise explanations and backup slides to support any discussion points. This week, we continued with Project Management/Overall Oversight and Safety.
Mock inspection (August 13, 2025): Today we’re running a full dry-run to rehearse our sponsor introduction, and how our Quality Management System is set up for these projects. Gero (QA) will play the inspector. Andreas Beust (Sponsor Rep), Thomas Kissner (COO), and Friederike (QA) will present on behalf of the sponsor/QA. Petra Stepankova (Head of QA) is on vacation and will rejoin only for the inspection itself.
What’s next: We’ll share behind-the-scenes impressions from the mock inspection and any final readiness updates ahead of day one in Cologne. If you have questions or stories to share, feel free to reach out. We are here to learn and improve together!
As GCP-Service gears up for its first ever inspection as a sponsor, the team took part in a full mock inspection to fine-tune their strategy and stress-test the key Sponsor presentation. Playing the role of inspector? Gero zur Hellen, QA Manager and Data Protection Officer at GCP-Service. CEO Andreas Beust sat down with him right after the session to discuss his observations, key takeaways, and what lies ahead.
Q: Gero, you just wrapped up your role as the mock inspector. What were your expectations going into this, and how did things actually play out?
My expectations matched quite closely with what ended up happening. I anticipated that you would give the full inspection presentation that had been prepared, covering the typical topics inspectors expect at the start of such a process. My role was to listen, assess the clarity and structure of the content, and ask probing questions where needed.
And that’s exactly how it went. Over the course of three hours, I was able to simulate the role of an external inspector, even though I’m internal to the company. That familiarity actually gave me an edge: I knew where some of the weak points might be, and I could target my questions to really test the robustness of our arguments and our readiness.
Q: Did you enjoy playing the role of inspector, or did it feel a bit strange acting as a third party while being part of the team?
I enjoyed it immensely. It was a rare chance to step outside of my usual role and view the team’s work from the perspective of someone assessing compliance and clarity rather than contributing to the documentation itself. It wasn’t entirely like being a third party, of course, because I already had insights into what could be improved. But that made it even more fun. I could really challenge you where it mattered and see how you’d respond.
Q: You even showed up in a suit, not your everyday office look. What inspired that decision?
It was all about creating the right atmosphere. I don’t normally wear a suit to work, none of us do really, but when you’re simulating an inspection, the tone matters. Inspectors often come dressed formally, and I wanted to set that expectation. I wasn’t just Gero from QA in that room, I was the inspector. Dressing the part helped the entire team shift their mindset. It helped make the experience more realistic and prompted everyone to treat the mock session with the seriousness it deserved.
Q: Let’s talk about the substance. What was your impression of the presentation and our overall state of readiness?
Overall, I’d say we’re in a solid place. The core content is there, we’re not missing critical pieces, and the presentation clearly reflects the scope of the inspection. That said, there are still things we can and should improve.
During the mock, we identified slides that could be moved or restructured to better support the flow of information. Some content can be removed or simplified, other parts should be expanded or clarified. A few elements are still pending input from other departments, so the presentation isn’t entirely finalized. But the foundation is strong.
I mentioned during the session that if this were a real inspection, I wouldn’t have issued any findings. However, I would have offered plenty of recommendations, not because we’re lacking, but because we have opportunities to polish our delivery and ensure everything lands as intended.
Q: What were some of the most useful improvements you saw coming out of the mock session?
The biggest change, in my view, will come from restructuring the order of some slides. Seeing when and how I asked questions helped identify where certain explanations should come earlier in the presentation. That way, you preemptively address potential questions instead of reacting to them.
We also realized that the presentation, while comprehensive, doesn’t need to be any longer. In fact, it’s about the right length. But clarity and flow can be enhanced by tightening transitions and making sure every speaker knows how their part fits into the whole.
In that sense, this mock served as quality control not only for the content but for the process of presenting it. That’s invaluable.
Q: During the mock, we received the draft inspection agenda. Any immediate thoughts on that?
Yes, I think it’s mostly aligned with what we expected. The initial five-hour slot on the first day seems well-placed for our opening presentation. What stood out to me was how well the mock session prepared us for that.
We spent about three hours today presenting and discussing, and the inspectors have five hours planned. That tells me they anticipate asking plenty of follow-up questions, but that’s okay. We’ve already demonstrated we can fill three hours effectively, and with more time and a few more voices involved, we’ll be in a good spot.
Q: Anything in the agenda that surprised you?
One thing I didn’t anticipate was the three-hour time block allocated for protocol deviations. That’s quite a lot, especially considering the trial is still ongoing and no formal analysis has been completed yet. We’re approaching an interim analysis, but the final results aren’t there yet.
Still, I’m curious to see what they’ll focus on in that slot. It could be a deep dive into how deviations are tracked and reported, or how they impact participant safety and data integrity. Either way, it’ll be interesting.
Another major focus is clearly vendor qualification and third-party oversight. That’s a critical area, especially because regulators understand no sponsor operates in isolation. It’s something we’ve prepared for, but seeing it highlighted so clearly on day two reinforces how important it will be to explain our vendor onboarding and management processes in detail.
Q: What are your expectations for the different inspection days?
Day two is going to be the most content-heavy and demanding. It focuses on vendor qualification, system oversight, and potentially multiple system demonstrations. That’s when most of the cross-functional coordination will be needed.
Day three wraps up with statistics and data management. Based on my experience, data management usually gets one to one-and-a-half hours max in audits. In this case, we’re scheduled for one hour, exactly what I expected. It will be short but focused.
Day one is all about setting the tone. That’s where today’s mock session really helps. Having practiced the opening session already gives us a head start.
Q: Now that the mock inspection is behind us, is there anything else you’ll be doing to prepare for the real inspection next week?
My role during the inspection will mostly be in the background, handling document access, retrieving files, and supporting the presenters. So my focus now is on making sure I’m familiar with the final set of documents. I want to know what’s available and where it is filed, so I can support the team quickly and efficiently.
Beyond that, I don’t have many action items. I suspect you and the others who are speaking directly to the inspectors have more to finalize in the coming days.
Q: Any final thoughts before next week?
I think we’re in a good place. Today gave us the confidence that we’re on the right track, but also the insight to make a few important adjustments. Everyone played their part well, and we treated the mock inspection seriously. That tells me we’ll be even more prepared when the real thing begins.
I’m looking forward to next week. It’s going to be intense, but also a chance to show the quality of our work.
The Road to the Inspection has taken an important turn. After a lot of preparation, our team at GCP-Service West has completed three intense days of regulatory inspection in our role as sponsor of two ongoing clinical trials. Now that the inspectors have left, it is time to reflect on what we learned.
A New Level of Intensity
Although we have hosted two inspections at our headquarters before and gone through more than a hundred audits as a CRO, this experience was different. As a sponsor, the level of scrutiny was on another scale. What we anticipated as challenging turned out to be even more intense than expected. Over the course of the inspection, five inspectors and five members of our GCP-Service team engaged in continuous discussions, sometimes in split sessions, accumulating over 30 hours of dialogue in just three days.
The Central Discussion: Our Quality Management System
One of the earliest and most central points of discussion centered on our quality management system (QMS).
At GCP-Service, we have operated with a single, integrated QMS that covers all entities within the company. Developed and refined for over 20 years, this system ensures that subsidiaries and branch offices follow the same processes and are integrated into it. When we stepped into the sponsor role, we followed the same approach:
We documented how responsibilities were split between sponsor and CRO.
We operated under the assumption that auditing ourselves would be redundant, after all, the same organization had created and maintained these processes.
From our perspective, this approach seemed logical. But from the inspectors’ point of view, the sponsor and the CRO must be treated as the separate legal entities they are. That difference in perspective sparked a controversial discussion that continued throughout the three days.
Patient Safety and Data Integrity in the Focus
Any formal outcome is of course pending, but the most important outcome seems clear: inspectors did not identify critical risks to patient safety or data integrity in the two trials under inspection. However, the feedback makes it clear that some process adjustments are needed to fully align with regulatory expectations.
The Daily Reality of the Inspection
The pace of the inspection was relentless. Questions asked on one day required answers prepared overnight for the next. Our team worked late into the evenings to refine documentation, improve accessibility of information, and anticipate the next round of discussions.
This process demonstrated the strength of our internal collaboration. Inspectors may have left at the end of the day, but our team continued working, ensuring that the next morning we could provide clear and structured responses. The effort showed the dedication and professionalism of the people at GCP-Service, a fact that makes us very grateful and proud.
Why This Inspection Matters
The inspection wasn’t just a test of our systems. It was also a validation of our vision. With our Sponsorship-as-a-Service model, we aim to make clinical trials accessible to smaller sponsors and investigator-initiated trials that don’t have the comprehensive infrastructure to handle all aspects of a clinical trial themselves.
This inspection gave us the unique opportunity to see where the daily practice of running clinical trials meets regulatory requirements and inspector expectations. The insights we gained will not only improve our own processes but also allow us to offer a clearer roadmap to other organizations facing similar challenges.
What Comes Next
For now, we await the written inspection report, which will take around four weeks to arrive. Once we have reviewed it and provided our responses, we will share a detailed interpretation of the findings. Our goal is to offer the clinical research community a validated blueprint of what it takes to act as a sponsor, manage vendors, and outsource tasks while safeguarding both patient safety and data integrity.
Until then, we will continue to sit down with colleagues who were part of the inspection to capture their perspectives and share further insights.
Three days, over thirty hours of dialogue, countless internal preparations, this inspection has been one of the most intense experiences in our company’s history. It has also been one of the most valuable.
Stay tuned as we continue to pave the path forward.
Andreas: We’re back with Episode 11 of the Road to the Inspection, after the inspection this time around. I’ve already shared my opinion, but other members of GCPS joined me on-site, and I wanted to catch up with them today. I have here with me Thomas from GCP-Service West, Gero, our data protection officer and part of the QA team, and Petra, our head of quality assurance from Prague. I want to get your impressions of the three days we spent together last week.
Thomas: For me, it was quite taxing, as I hadn’t participated in many of these discussions before. Listening to everything was a lot, but I found the inspectors’ feedback and their outside perspective on how we execute our trials to be super insightful.
Andreas: Gero, how was it for you? This was your first inspection, and the stakes were quite high. It was also an unusual setting for you to be present for all three days.
Gero: It was both exhilarating and exhausting. I was more in a background support role, but it was still quite tiring because there was a lot of work to do. It was also very interesting. It was really cool to see how we all worked together to deliver something.
Andreas: Awesome. Petra, you’re next.
Petra: The experience was very interesting for me because it was held in German, and I’m not fluent in the language. I only caught some words, and since I always try to provide immediate support, I was a little delayed. I was dependent on some translation. Also, you always have a perception that time flies much faster during an inspection than it does in reality. But overall, it was a great experience and, as Thomas said, it provided great insight from an external perspective, especially from the inspector’s point of view, and there were great discussions on some aspects. It was a very fruitful experience for me.
Gero: The data management part. I’m a former data manager, so obviously, that was where I could contribute and where I understood the most. What the inspectors requested was also interesting because usually, the people you work with are not that fluent in data. But they were, and it was really cool to see what they could actually do with the data we provided them.
Andreas: Awesome. Petra?
Petra: Not surprisingly, as the head of QA, the highlight for me was the QMS itself. The discussion about a shared QMS and how to handle it for the sponsor versus the CRO was the most important and interesting part. It was helpful to share our thoughts from the inspector’s point of view and see how we could handle that according to their interpretation.
Andreas: Awesome. And Thomas?
Thomas: The inspectors’ high-level understanding of our systems was amazing. They gained insight into the system and TMF artifacts in only a few minutes, grasping how the system is structured so quickly. Because of this high level of insight, we didn’t have to provide much explanation.
Andreas: We’ve walked through these three days, and I think for all of us, it was quite taxing and intense. We spent a lot of time on it and learned a lot.
Petra: That’s a good question. I would say we will look into the quality management system, which was confirmed as a good one, despite the difference in approach to a shared QMS. I will try to look at the QMS itself with the team from a different perspective, from the point of view of the inspectors. Then we can decide what should be implemented and at what level. So for me, the main focus is on the QMS part and general compliance, as is always the case after each inspection. I’m sorry, I don’t have an exact plan yet because this is still under consideration on my part: how to look into the QMS and the shared QMS from that perspective.
Andreas: Yes, we’re early in the process.
Petra: Yes, it’s early.
Andreas: Gero?
Gero: We should add a sixth person. The inspectors technically had six people, though one was not there. At times, it was hard for us to handle everything, especially because there were split sessions, which meant we had to divide our team. As I said, the background support sometimes got very busy in those situations. One additional person would have been really useful and would have made it easier for all of us to provide support.
Andreas: For me personally, I would also add the two project managers. I represented the project as the sponsor, but for next time – I fully agree with you – I would simply have the people who spent a thousand hours on the project sit in on the inspection as well. This time they were both on vacation, so there was no way around it. But next time, I’m sure we’ll find a different solution.
Thomas: And don’t forget the TMF expert, since picking out a lot of new documents is taxing and they know exactly where to find things. In general, regarding the project, I think we need to reflect on which critical processes and data we have, and then see how we want to handle them. We should focus on those parts.
Andreas: Awesome. I’m sure there’s much more to discuss, and we will discuss it once the inspection report is released. Then we can go through everything that was found and reported to us and have structured conclusions. But for now, I really appreciate your insights. It was lovely spending last week with you. It’s great to be back and to catch up already. I look forward to catching up with you all again soon.
