Synergy Research

Customizable operational support for global Phase I–IV clinical trials covering project management, feasibility, site selection, study start‑up, recruitment, monitoring, medical monitoring, safety reporting, TMF management, and trial closeout.

Design, development, and maintenance of clinical and safety databases, CRF design, EDC deployment and training, IVRS support, data cleaning and query management, SAE reconciliation, medical coding, database lock/transfer and archival.

Statistical design and analysis support including sample size calculations, SAP development, statistical modelling, RWD analysis, interim and final statistical reporting, and independent biostatistician support for monitoring committees.

Comprehensive pharmacovigilance services including safety and risk management plan generation, case processing and aggregate reporting, global literature surveillance, signal detection and trend management, QPPV services, and periodic regulatory safety reporting.

Regulatory strategy and planning services for drugs, devices, OTCs, and medical foods to support preparation and execution of regulatory submissions and facilitate regulatory approval pathways.

Preparation of preclinical, clinical, and regulatory documents including study reports, regulatory submissions, labeling, and safety documentation.