The Right Team in an Environment of Constantly Changing Regulations
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
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!