Services
clinical investigation
The types of clinical trials (from a regulatory perspective) are illustrated in the adjacent diagram.
We determined which type of clinical trial is suitable for your case during the "Pre-Study Phase." The subsequent procedure is therefore based on the regulatory framework (MDR, and, for example, in Germany: DVG, DIGAV, or DIGA Guidelines, etc.).
Furthermore, we validate all documents you have prepared for your clinical trial with regard to regulatory requirements.
In most cases, clinical trials for medical devices consist of 2 phases:
Phase 1: Planning your clinical trial
- Development of the objective of the clinical trial as well as its design, endpoints, and possible procedure (number of visits)
- statistical activities (e.g. creating the sample size plan)
- Creation of the test plan based on the case number plan
- Compilation of the registration documentation (including patient information, declaration of consent, examiner's brochure, safety clearance, etc.)
- Submission of documents to BOB and EK
- Recruitment of examiners and testing centers
- GCP training for investigators
Phase 2: Conducting your clinical trial
1. Monitoring (remote monitoring and on-site) including, if necessary, audits (planning and execution):- Pre-Study Qualification (PSQ)
- Initial Visit
- Monitoring visits
- Close-out visit including preparation and follow-up with report creation
- Creation of the CRF, mappings and template for data extraction from the database in the case of eCRF or for data entry in the case of pCRF
- Creation of the statistical analysis plan (SAP)
- Possibly including the CRF in our Clinical Data Management System (CDMS) as an eCRF
- Training on database entry and data maintenance for eCRF and on data collection for pCRF
- statistical data analysis