Comprehensive clinical trial support across Phase I–IV with regulatory excellence
Assessment of study feasibility and regulatory requirements to support successful clinical trial initiation.
Identification and evaluation of clinical sites based on capability, patient availability, and compliance readiness.
Preparation and submission of study documents to ethics committees in accordance with regulatory guidelines.
Compilation and submission of regulatory dossiers to health authorities to support clinical trial approvals.
Development of clinical study documents including protocols, reports, and regulatory submissions.
End-to-end coordination of clinical trial activities to ensure timelines, quality, and budget adherence.
Operational oversight of clinical trials and investigational sites to ensure protocol compliance.
On-site and remote monitoring to verify data accuracy, patient safety, and regulatory compliance.
Management of central laboratory activities including sample handling, logistics, and data integration.
Design, validation, and management of clinical databases to ensure high-quality and reliable trial data.
Statistical planning and analysis to support clinical study design, data interpretation, and reporting.
Continuous monitoring and evaluation of adverse events to ensure participant safety and regulatory compliance.
Independent quality oversight through audits and inspections to ensure adherence to GCP standards.
Identification and mitigation of clinical trial risks to protect data integrity and study outcomes.
Training programs to ensure investigators and site teams are compliant with study protocols and regulations.
Strategic support to enhance patient enrollment, engagement, and retention throughout the study.
