Consulting on clinical trials
pursuant to CTR and MDR

"Demonstrating the efficacy and tolerability of your medicinal product or the safety and performance of your medical device requires a scientifically sound and regulatory-compliant strategy, professional management of clinical trials (Clinical Trials / Clinical Investigations), and careful documentation at every stage of implementation to support the corresponding submission."

With the entry into force of Regulation (EU) No. 536/2014 (CTR), as of January 31, 2023, applications for clinical trials for medicinal product must be submitted to the authorities and ethics committees via the new European portal, CTIS (Clinical Trial Information System). This brings with it new requirements regarding technical specifications, the format and preparation of submission documents, as well as revised deadlines.

With the introduction of the Medical Devices Regulation (EU) 2017/745 (MDR), the scope and importance of clinical evaluation for medical devices have significantly increased.

Generating clinical data is frequently required to demonstrate the safety and performance of a medical device.

Clinical investigations may be necessary both for conformity assessment (CE marking) and post-market surveillance as part of Post-Market Clinical Follow-Up (PMCF).

beratung bei klinischer arzneimittelzulassung

We handle the following on your behalf:

● Consulting on clinical trials for medicinal product and medical devices

● Preparation of IMPD (Investigational Medicinal Product Dossier), protocol, case report form (CRF), final report, etc.

● Submission of your clinical trial application to the competent authority and ethics committee via the

  • German Medical Devices Information and Database System (DMIDS)

  • Clinical Trial Information System (CTIS)

    • Consulting and training on the Clinical Trial Information System (CTIS)

Your Benefits:

beate beime pharma consulting oldenburg

  • Over 25 years of experience dedicated to your project

  • Development of tailored strategies

  • Planning certainty through alignment with regulatory authorities via Scientific Advice

  • Our persistent objective: Streamlining the clinical development program

  • Professional project planning and timely project management from clinical trial to marketing authorization