Clinical Investigations and Performance Studies
Clinical studies for medical devices and in vitro diagnostics (IVDs) follow a structured process, typically divided into three key phases. Each phase comes with specific regulatory requirements and deliverables, in line with:
- ISO 14155 – Clinical investigation of medical devices for human subjects – Good clinical practice
- ISO 20916 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice.
The overview below outlines what each phase includes – from planning to completion.
Phase 1 – Pre-Study
Purpose:
Lay the regulatory and operational groundwork
Includes:
- Study design and endpoint definition
- Biostatistics
- Clinical Data Management
- Feasibility and site selection
- Development of Clinical Investigation Plan (CIP) / Clinical Performance Study Plan (CPSP)
- Development of Informed Consent Plan
- Preparation and application of submission packages to Ethical Committees and Competent Authorities
Phase 2 – Study Conduct
Purpose:
Execute the study in accordance with the CIP/CPSP and Good Clinical Practice (GCP)
Includes:
- Site initiation and monitoring
- Clinical Data management coordination
- Safety management and medical monitoring
- eTMF setup and ongoing maintenance
Phase 3 – Study Close-Out
Purpose:
Finalize study documentationand ensure compliance
Includes:
- Database lock and data analysiscoordination
- Biostatistical analysis
- Development of Clinical InvestigationReport (CIR) / Clinical PerformanceStudy Report (CPSR)
- eTMF reconciliation and archiving
- Close-out visits and authority follow-up
Clinical Project Manager Services
From study design to final report – expert guidance at every step.
A Clinical Project Manager (CPM) from GBA Key2Compliance is more than a coordinator. Acting as your trusted clinical advisor, our CPMs guide yourstudy from idea to completion – ensuring scientific integrity, regulatory alignment, and operational excellence throughout.
What Sets Our CPMs Apart
Whether you’re preparing a first-in-human (FIH) study to demonstrate proof-of-concept on an early prototype, planning a validation study for CE-marking, or conducting post-market clinical or performance follow-up (PMCF/PMPF), our CPMs act as your clinical lead and single point of contact throughout.
The CPM contributes directly to study design, manages protocol and submission development, handles communication with authorities, and ensures alignment with both your business goals and regulatory demands.