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
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 
2. Data management:
  • 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 
3. Preparation of the clinical investigation report (final report of the clinical investigation)

medXteam GmbH

Hetzelgalerie 2 67433 Neustadt / Weinstraße
+49 (06321) 91 64 0 00
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