Regulatory Affairs

Regulatory support from the start-up phase and throughout the conduct of your clinical trial

The regulatory start-up process is the first critical path of a clinical trial. Even small delays can impact entire study timelines. At GCP-Service we believe it is most important that we ensure a timely start-up of your clinical trial.
Our Regulatory Affairs services support your project with experience and dedication to deliver state of the art results. With our oversight and knowledge of common pitfalls, we avoid potential delays when managing your clinical trial applications – both in pharmaceutical as well as medical device trials.

The Right Team in an Environment of Constantly Changing Regulations

Obtaining the approval and the positive opinion for a clinical trial application is heavily dependent on two factors, the trial outlines and the team working on them. Firstly, it is important to understand how and why decisions are made by competent authorities and ethics committees/IRBs. The evaluations that take place by these bodies are done so under either scientific or patient-safety aspects. These processes are not designed to bother the applicants unnecessarily, but to filter out bad trial designs and/or products that are not developed to the point they are ready to begin clinical trials yet. Secondly, Regulatory Affairs Managers at GCP-Service understand the sponsors need for fast and positive replies as well as the authorization processes’ goals. We have developed a very successful communication approach between stakeholders that aims for the best results regarding application outcomes as well as an ideal approach for trial participants.

The multi-disciplinary composition of our regulatory affairs team helps us identify the needs and goals of all stakeholders involved in the clinical trial application process. We offer a variety of services throughout the lifetime of a clinical trial including:

  • Feasibility Process including the use of our state of the art online tools
  • Clinical Trial Applications to the Competent Authority
  • Clinical Trial Applications for Ethics Committee/IRB Opinion
  • Experience with relevant electronic portals where possible to conduct timely submissions
  • Experience with pharmaceutical trials Phase I-IV as well as non-interventional studies (NIS)
  • Experience with pre- & post-market Medical Device trials
  • Support throughout the whole period of the trial conduct:
    • Review of essential documents
    • Close contact with IRB and CA to solve any issues
    • Initial submission & answers to requests
    • Substantial / Non-substantial Amendments
    • Annual Reports / DSURs
    • Posting of study results to legally required portals

Our Services

The services offered by our Regulatory Affairs Managers include all the applications, notifications, and communication steps as listed above. We would now like to highlight certain elements that are highly depending on the competence of our people listed below.

Our services include:

Communication is key when it comes to the solution of a tricky task. Our communication in regulatory processes focuses on the goal ahead and not unnecessarily backwards.

Our solutions to requests from ethics committees / IRBs and competent authorities prove that our team uses the right goal-oriented communication both within the study team and to our external stakeholders. Focusing too long on things that don’t work doesn’t solve problems, it reinforces them.

Our expertise in clinical trial applications gives us the ability to detect potential hurdles in the trial design before the application is sent. Even though we personally do not approve or deny a trial, we can minimize the findings and therefore the time and cost needed to get your trial approved and ready to begin.

Within GCP-Service International we not only have the expertise to support your trials from a regulatory point of view, but also from the views of our team of diverse experts. Our project managers streamline the different processes in the start-up phase of a clinical trial. Processes include the feasibility process, the selection of the sites, preparation of the essential documents e.g. by our Medical Writing department, and the communication with you as the sponsor.

As part of the Association of International CROs (AICROS) we cover the entire globe with our regulatory affairs services. If you are aiming for a multinational clinical trial project we can coordinate the entire project providing a single and concise point of contact.

Choose experience and flexibility now!

We currently use the most recent available electronic application possibilities. Paper-bases submissions are still often a legal requirement and have only recently been lifted under certain provisions (data protection, covid-19 etc.) Our team is ready to meet both electronic and paper regualtory needed. Of note have been actively using electronic methods before the era of paper-based clinical trial applications was predicted to come to an end. As Part of new EU-Regulations, regarding clinical trials with pharmaceuticals and medical devices, the implementation of web-based submission processes will replace the old model of paper copy submissions. As competent authorities and ethics committees are preparing for centralised web portals to come, some already offer web-based solutions in advance. This gives us the opportunity to gain insight on what’s to come in the world of electronic applications and our currently methods already place us, and your company, in a head start position.