Consulting on Clinical Trials
in accordance with CTR and MDR

“Demonstrating the efficacy and tolerability of your drug 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 of medicinal products must be submitted to the regulatory authorities and ethics committees via the new European portal, CTIS (Clinical Trial Information System). This is accompanied by 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 the clinical evaluation of medical devices have increased.

To demonstrate the safety and performance of a medical device, it is often necessary to generate clinical data.

Clinical trials may be necessary both for conformity assessment (CE marking) and after the device has been placed on the market as part ofpost-market clinical follow-up(PMCF).

Consulting Services for Clinical Drug Approval

We'll take care of the following for you:

● Consulting on clinical trials for drugs and medical devices

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

● Submitting your clinical trial application to the regulatory agency and ethics committee via the

  • German Medical Device 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 for your project

  • Developing Tailored Strategies

  • Planning Certainty Through Coordination with Authorities via Scientific Advice

  • Our ongoing goal: Streamlining the clinical development program

  • Professional project planning and on-time project management, from clinical trials to regulatory approval