A clinical study designed without regulatory input becomes 18 months of expensive data that don't answer FDA's questions.
Our solution
Regulatory-driven clinical strategy: endpoint selection for drugs/devices or combination products, BLA/IDE submissions, ICHE6(R3), ISO 14155 GCP, statistical analysis plan. Our experts review your clinical evidence for compliance with EUMDR, EUIVDR and clinical/performance evaluation requirements, without late-stage surprises.
Process
How we run this engagement.
Pre-Sub for endpoint alignment (drugs or devices)
IDE or IND authoring or support
Site selection & investigator briefing
Trial monitoring & data integrity in Trial Master File
Clinical Study Report or Clinical Evaluation Report
IDE, clinical protocols, ISO 14155 studies, real-world evidence.
How we help
Regulatory-driven clinical strategy: endpoint selection, IDE submissions, ISO 14155 GCP, statistical analysis plan.
