Services
clinical investigation
We have shown the types of clinical trials (from a regulatory perspective) in the diagram opposite.
We worked with you in the “pre-study phase” to determine which type of clinical trial is suitable for you.
The further procedure is therefore based on the regulatory framework (MDR, and for example in Germany: DVG, DIGAV or DIGA guidelines, etc.). We also validate all documents that you have created for your clinical trial with regard to the regulatory requirements.
In most cases, clinical investigation for medical devices consist of 2 phases:
Phase 1: Planning your clinical investigation
- Development of the goal of the clinical trial as well as design, endpoints, possible procedure (number of visits)
- statistical activities (e.g. creation of the sample size calculation)
- Creation of the clinical investigation plan based on the sample size calculation
- Compilation of registration documentation (including patient information, declaration of consent, investigator brochure, safety-related harmlessness, etc.)
- Submission of documents to federal authority and ethics committee
- Recruitment of investigators and investigation sites
- GCP training of auditors
Phase 2: Conducting your clinical investigation
1. Monitoring (remote monitoring and on-site) including, if necessary, audits (planning and implementation):- Pre-Study Qualification (PSQ)
- Initiation Visit
- Monitoring visits
- Close-out visit including preparation and follow-up with creation of reports
- Creation of the CRF, mapping and template for data extract from the database at eCRF or for data entry at pCRF
- Creation of the statistical analysis plan (SAP)
- If necessary, inclusion of the CRF in our Clinical Data Management System (CDMS) as an eCRF
- Training on database entry and data maintenance for eCRF and data collection for pCRF
- statistical data evaluation