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.
![4 studies](https://www.medxteam.de/images/cliparts/studien_en.png)
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