CRA monitoring
Site qualification visits, SIV, interim monitoring visits, close-out visits, SDV/SDR, protocol compliance oversight, and issue escalation.
View CRA monitoring servicesFreelance CRA and clinical trial consultant for Germany and the EU
With over 18 years of experience in clinical research, including pharmaceuticals and medical devices, I support clinical study execution in full compliance with ICH-GCP, EU Clinical Trials Regulation, MDR, and ISO 14155 requirements.
Projects can include monitoring, feasibility, site selection, regulatory planning, CTA/CTIS preparation, ethics committee submissions, and direct communication with local authorities and clinical sites.
Why work with a freelance Clinical Research Associate?
- Direct communication with a senior expert instead of extra handover layers.
- Lower operational overhead and faster decision cycles during start-up and monitoring.
- Practical understanding of German and EU regulatory expectations.
- Regional coverage with reduced travel burden for sites in Germany and neighboring countries.
Clinical trial services
Study start-up Germany
Feasibility, investigator identification, document localization, contract support, and preparation of submission-ready start-up packages.
View study start-up servicesRegulatory affairs and CTIS
CTA strategy, Part I/Part II dossier support, ethics submissions, authority communication, and medical device regulatory coordination.
View regulatory affairs supportTherapeutic areas
- Oncology: breast cancer, AML, ALL, and lung cancer studies
- Cardiovascular and interventional medical device studies
- Neurology, ophthalmology, pain, rheumatology, and gynecology
- Medical devices including cardiac and ophthalmic technologies
Regulatory and study systems
- BfArM, PEI, EMA, CTIS, EUDAMED, EudraVigilance
- Ethics committees, BfS, and BOPST where required
- Veeva Vault, Medidata Rave, Oracle Clinical, eCRF, eTMF, RTSM
- ICH-GCP, EU CTR, MDR, and ISO 14155-aligned documentation
Plan your next clinical trial in Germany
For collaboration on monitoring, start-up, CTIS, or regulatory affairs activities, please use the contact form and include your study phase, target countries, indication, and expected timelines.