Compliance with ICH-GCP is a cornerstone of clinical research. Any failure can result in negative audits, delays or data invalidation. Relying on properly trained and supervised local teams is a key risk-mitigation strategy.
1. Why GCP compliance is non-negotiable
Good Clinical Practice ensures:
- participant protection,
- data integrity,
- scientific credibility of results.
GCP applies at every stage: patient inclusion, follow-up, source documentation, data management and reporting.
2. The critical role of local teams
Local teams (CRAs, CTAs, study coordinators, data managers) are central to clinical operations:
- patient follow-up,
- source documentation management,
- protocol compliance,
- coordination with sponsors and CROs.
In Madagascar, many professionals are already trained and experienced in international projects.
3. The Pharmaspecific Portage model
Pharmaspecific Portage ensures:
- rigorous candidate selection,
- mandatory GCP training,
- strict SOP implementation,
- audit preparation and support,
- full data traceability and quality control.
This model significantly reduces operational risk for sponsors and CROs.
4. Time, quality and cost efficiency
Local teams enable:
- stronger field continuity,
- reduced international travel,
- faster responsiveness,
- improved timeline and budget control.
They represent a strategic lever to secure and accelerate clinical research.
