GCP-Service International Ltd. & Co. KG. offers its services via two different service provider models depending the needs of the sponsor. Our Service Strategy offers a Full Service and a Functional Service Provider Model.
The Project Manager of GCP-Service is the main sponsor contact for the whole project. Thus the key competence of our Project Managers is communication to drive the clinical trial studies from beginning to end by steering the different stakeholders through all study phases in order to comply with the agreed timelines. The Project Management of GCP-service ensures all involved parties are fully informed of – and are adhering to – study requirements and therefore oversee timelines, scheduling, task assignments and financial tracking.
Our highly skilled Project Management team, supported by the electronic Project Management tools GCP-Service has developed, ensures that even large international projects are maneuvered through all challenges that such studies entail.
During the last decade the process of clinical monitoring has changed significantly. Even though statistics showed that the impact of clinical monitoring quality of clinical data is not as high as assumed in the past. The need for CRAs who understand their role as a supporting function for study sites and sponsors to reach robust study data and to ensure the protection of subject welfare as well as subject rights has never been higher. The development of CRAs to consultants who provide an added value to every study is our vision for clinical monitoring since the last couple of years. We support sponsors to find the right balance of clinical on-site monitoring and remote monitoring activities to make sure that the best study quality can be reached according to the purpose of the study.
For centralized monitoring statistical information e.g. SDs, trends, outliers are monitored by our statistical department. This process supports the clinical operation team to react on conspicuous data effectively.
The management of study documentation is crucial to the success of a clinical trial providing means to evaluate study conduct, data integrity and compliance with regulatory standards. Over the years, the extent of such documentation grew exponentially, requiring more and more capacities from project teams and study sites. Especially in the light of paper-based documentation and evermore complex studies, this asks for innovative and efficient ways of document management, such as our electronic Trial Master File (eTMF) and electronic Investigator Site File (eISF).
Electronic TMF Management is more than filing documents into a digital deposit. In fact it significantly improves transparency and oversight during study conduct.
With our support we help our clients to streamline the process of conducting reliable and high quality feasibilities.
Keeping timelines in clinical studies is always critical. Therefore, an effective feasibility and an excellent site selection process are crucial in the early stage of clinical trials. Carrying out high quality feasibility reviews and study site selections for large clinical trials are extremely time and cost intensive. For multicentre studies, around 3-4 hours per study site need to be spent to receive reliable feasibility data. GCP-Service’s PI-Select system is a very effective site selection and feasibility tool that significantly reduces manpower, time and costs for the essential start-up phase by delivering excellent results.
Next to the welfare of study subjects, data integrity and data quality are the most important objectives of Good Clinical Practice in clinical research. We understand Data Management as a process of data validation and data processing and not only the collection of data. Thus data management at GCP-Service is more than writing checks or control data, we provide the basis for a reliable statistical analysis.
Besides safety and right of study subjects, the quality of data is the most important measure of a successful clinical trial of our clients.
Our highly skilled and educated Data Management team has developed an innovative and flexible electronic data capture (EDC) system and related processes which ensure data integrity and accountability. We will accompany you from database setup to database lock, so that you will have an experienced partner combined with advanced technology at your side. Our systems, SOPs, and personnel are equipped to manage paper-based data capture as well as electronic data capture. This allows us to have customised, reliable and cost-effective solutions for clinical data management (CDM) operations ready to use.
Supported by our leading-edge data management systems and integrated SOPs, our CDM staff can fulfill unique project requirements, such as:
Establishment of sponsor-defined CRFs
Customized query wording for clarity and conciseness
Accelerated query management
Unscheduled data reviews
Study timeline changes
Changes to protocol, CRF template and project specifications
Our flexibility in accommodating changes to project specifications is paralleled with a quality maintenance of study data and adhering to expected study timelines.
The use of EDC should be kept as simple as possible. QCTMS® EDC lets physicians, researchers and their personnel capture the data of research to be acquired specifically and individually and to analyze them in a standardized manner. Our EDC system provides the following features and benefits:
• Timely and rapid data acquisition and reporting
• Integrated data check for completeness and plausibility
• Integrated query management
• Standardized documentation of adverse events
• Individually configurable roles and authorizations
• Simple and safe to use thanks to our “next steps” philosophy
• Data output in any desired format
Our EDC system is extremely cost effective which makes it a useful tool even for clinical studies with a small number of patients. The combination of our EDC with our Clinical Trial Management System (QCTMS) improves quality but also saves money by saving man-power. After a very short time project teams will recognise the benefit of these unique systems.
The interactive response technology of QCTMS® IRT allows centralized web-based randomization and drug assignment in an extremely user friendly way. We know that site personnel are normally not very used to sophisticated IT environments; this fact alone allows us to develop a simple, easy-to-use electronic tool ensuring compliance by every user.
The advantages of QCTMS IRT are:
• Flexible system which can be used for every study design
• Up to 5 stratification parameters in one trial
• Easy to use, intuitive and user-friendly
• Connection to QCTMS for quality control of randomization data
• Controlled code break option
• 21 CFR Part 11 compliant
This smart and easy-to-use tool allows centralized data entry for patient diaries and questionnaires in a user friendly way. We know that patients in clinical trials are often not familiar with IT environments. Therefore we developed a simple electronic tool ensuring compliance by every user.
The main features of the QCTMS® ePRO are the following:
• Timely and rapid data acquisition and reporting
• Integrated data check for completeness and plausibility
• Individually configurable roles and authorizations
• Overall data quality improvement
• Available in all languages
• Cost effectiveness
Having both services under one roof offers you many advantages:
• Less costly
• Easy and secure data transfer
• Our analysis starts right after data base lock
• No problems with different software or software versions
• No export and import problems
Don’t hesitate to contact us if you have any questions or comments – we are here to support you!
Do you want to outsource your whole product vigilance process or just part of it? GCP-Service can take on the whole process for small and medium sized companies (medical device companies and pharmaceutical companies).
Alternatively, our team is able to perform any specific task where your company may have a temporary lack of resources. We have a complete suite of SOPs covering all product vigilance activities interfacing with your SOPs.
We can support your company with pharmacovigilance service including QPPV, PSMF, case processing and reporting, literature searching, periodic reports, safety monitoring, signal detection, maintenance of core safety information, etc.
Our team can support your medical device company with case processing and reporting, literature searching, periodic reports, safety monitoring, signal detection, maintenance of instruction for use etc.
GCP-Service can provide a full case management service for companies with a small to medium through put of cases. The service may include any or all of receipt, assessment and triaging, coding, data entry, quality control, medical review, follow-up, expedited reporting cases to competent authorities or partners (e.g. Ethics Committees), medical writing, electronic reporting and reconciliation. We can perform tasks via affiliates, partners or directly in countries where we have the language competence.
The GCP-Service team is fully trained in use of the EudraVigilance Webtrader and has extensive experience in submission and receipt of ICSRs and SUSARs for a number of clients.
GCP-Service can offer:
• Registration to EudraVigilance on behalf of the pharmaceutical company as Trusted Deputy
• Electronic transmission of ICSRs and SUSARs to Competent Authorities and EMA through EudraVigilance
Our personnel are experienced in data entry into a range of pharmacovigilance databases. To tide you over those temporary resource issues due to higher than usual case through put, staffing gaps, database upgrades or system mergers or other reasons, we can “fill that gap” by providing your database supports remote entry.
GVP Module VI requires companies to carry out weekly literature searches in at least one “widely used systematic literature review and reference database”. GCP-Service can carry out these searches using PubMed. Alternatively, we can review the results of in-house searches routinely, documenting the review and outcome, identifying case reports and other citations that may be relevant to the safety profile of your medicinal products for PSURs and signal detection.
We can also run your literature searches for the period covered in the PSURs, in order to identify any citations relevant to the safety profile of the product(s) concerned.
• clinical study reports
• clinical study protocols, clinical investigational plans (CIPs)
• investigator’s brochures
• clinical overviews
• clinical summaries
The GCP-Service legal representative service was established in order to meet legal requirements of sponsor companies which do not have a subsidiary within the European Union and Switzerland, for the purpose of performing clinical research projects in this region.
Such a “legal representative” for clinical drug trials or “authorized representative” for medical device trials fulfills the obligation that the sponsor companies must be established or represented in the European Union.
We can represent you in all member states of the European Union for your drug and medical device trials to enable submission of your regulatory applications to the European authorities and ethics committees. Our understanding of the responsibility of legal reprehensive is that our team takes care that our non EU clients comply with EU regulations.
We offer support for you and your contracted local CROs who might not be able or experienced to provide required representation services.
A group of highly experienced regulatory experts at GCP-Service will provide you with competent, quick and cost-efficient representation services.
Legal representation services are based upon:
✓ The regulation EU No 536/2014 requires that for all clinical studies with pharmaceuticals in the European Union a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area.
✓ The Medical Device Directive 93/42 EEC requires that for clinical studies with medical devices a manufacturer or an authorized representative is established in the European Union.
The role of the legal representative should be a trustful partner of the sponsor who knows the EU regulations well. Our repeat business rate of nearly 100% shows how our clients rely on our team and our expertise. We are not just a post box, we are an added value.
Our Services include:
• We operate in more than 30 countries
• We ensure ICH E6 and/or ISO14155 compliance
• We prepare your sites prior to inspections by national and international authorities
• We are flexible and extremely cost effective
• We can provide oversight to foreign sponsors by using electronic Trial Master Files (eTMF/eISF) according to the EMA reflection paper on TMF
The conduct of clinical studies has been changed significantly with the new ICH E6 (R2). GCP has been modernized; Quality Management Systems should have complete new components to reflect the project specific risk analysis. These changes also require a new way of auditing. Auditing as it has been done in the past does not match with the expectations of the authorities. GCP-Service performs project audits for you in order to review the quality of the study performance within mono and multi-centre studies. This service includes the review of study compliance in terms of:
• Risk analysis
• Ethical norms
• Laws and regulations (physicians law, drug law)
• ICH E6 (R2)
• ISO 14155
• Contractual agreements
Additionally, GCP-Service offers independent system audits at your selected vendors. We include personal with experience in the particular system which needs to be audited e.g. IT system, EDC systems, vigilance systems, study sites, pTMF/eTMF etc. These audit includes a comprehensive review of key documents such as SOPs, training documents, project plans and other documents relevant for the quality of implemented systems.
Generally, the purpose of audits conducted by GCP-Service is to improve the quality of clinical projects on a long term run. If necessary, study personnel such as site staff or CRO staff may be provided with further training on ICH GCP, drug law and regulations in a constructive and mutually beneficial way.
The QA managers of GCP-Service have more than 17 years of clinical research experience. They can support you with risk management in your company and help to develop efficient systems capable of reducing risk and enhancing in-house quality.
The conduct of clinical studies can only be justified if these are appropriately planned, accomplished, evaluated and reported ethically and scientifically. These requirements call for implementation of functional quality management systems in all departments involved in the conduct and monitoring of clinical studies. Regulatory requirements and the complexity of study designs are increasing. Hence, many sponsors and CROs are aware of the fact that the existing quality assurance activities such as audits alone are not suitable methods to ensure the required quality of clinical trials. The FDA guidance about risk adapted clinical monitoring, the EMA reflection paper on quality risk management and many parts of the amended ICH E6 (R2) show how urgent a change of mindset was needed. What GCP-Service offered its clients since several years as company philosophy is now a legal requirement. Our team has QRM expertise of many years, uses validated processes and has developed highly advanced electronic tools to comply 100% with the expectation of the inspectors.
The new Medical Device Regulation (MDR) and the new In Vitro Diagnostic Regulation (IVDR) is quite confusing and demanding for medical device manufactures and especially for smaller manufacturers as well as for companies with low to medium risk devices. We want to help such companies to bring light into the dark. If you follow new regulatory processes for the first time, they usually seem to be scary, expensive and time consuming, however this does not need to be the case. Due to the urgent consultancy need we at GCP-Service established a special consultancy taskforce group for medical device companies which need support with the clinical development of their medical devices. We can support you with:
– Development of a study design that proves the performance and safety of your product;
– The sample size calculation to collect robust data;
– Preparing an investigational plan;
– Train your staff in the conduct of clinical trials with medical devices;
– The selection of reliable investigators and cost-effective countries;
– Preparing Clinical Evaluations;
– Regulatory consultancy;
– All other tasks which might help you to bring your product to the market.