Study Feasibility Support

Accelerate clinical trial success with our expert study feasibility services, ensuring seamless execution under GCP for human studies and GLP for veterinary trials. We assess site capabilities, patient recruitment, and operational risks to select optimal locations and timelines, minimizing delays and costs.

Comprehensive feasibility assessments evaluate investigator qualifications, patient pools, infrastructure, and regulatory readiness per ICH E6(R3) GCP guidelines. We deploy standardized questionnaires to gauge recruitment potential, staff training, and protocol adherence, supporting FDA, EMA, CDSCO, and global submissions with documented risk mitigation.

For preclinical and veterinary trials, we ensure GLP compliance (OECD 14, VICH GL9) through facility audits, animal availability analysis, and bioanalytical validation feasibility. Services cover PK/PD studies in target species, dose formulation stability, and endpoint achievability for IND/IMPD veterinary dossiers.

Site feasibility reports with recruitment forecasts and timelines

Risk registers aligned with ICH E6 risk-based quality management

Budget and resource modeling for multi-center execution

Regulatory interaction support for feasibility data in CTA/IND packages