Consulting for clinical trials according to CTR and clinical investigations according to MDR
“The proof of efficacy and safety of your medicinal product or the safety and performance of your medical device requires a sciene-based strategy that complies with regulatory directives, as well as professional management of clinical trials / clinical investigations and careful documentation for the relevant filing during each phase of implementation.”
With the entry into force of Regulation (EU) 536/2014 (CTR), clinical trials for medicinal products must be submitted to the authorities and ethics committees via the new European portal CTIS (Clinical Trial Information System) as of January 31, 2023. This is accompanied by new requirements for the technical prerequisites, type and preparation of the submission documents, as well as changed deadlines …
In addition, clinical trials approved under the previous law must be transferred to CTIS by January 31, 2025 at the latest in order to be allowed to continue. The transfer requires a conversion of the trial protocol to comply with CTR, possibly also harmonization of the (national) trial protocols as well as a new application procedure in CTIS and should therefore be strategically planned in a timely manner.
Paediatric application in the Paediatric Investigation Plan (PIP) and the current requirements of benefit assessment we also take into consideration.
An important milestone in your project is accomplished through coordination and monitoring of clinical projects in scientific advice meetings with regulatory authorities.
We offer the following services:
Consulting on clinical trials / investigations for medicinal products and medical devices
Creation of IMPD (Investigational Medicinal Product Dossier), trial protocol, case report form (CRF), final report, etc.
Clinical trial application to the authorities and ethics committee via the
German Medical Devices Information and Database System (DMIDS)
Clinical Trial Information System (CTIS)
Consulting and training on the new Clinical Trial Information System (CTIS)
Planning and strategy for the transfer of currently running trials into CTIS (transitional trials)
Benefits for you:
Your project benefits from experience spanning over 25 years
Development of customized strategies
Our ongoing objective: streamlining the clinical development programme
Planning reliability through consultation with the authorities in scientific advice meetings
Professional project planning and timely project management from clinical testing to approval