Clinical Data Management
Robust Data Management & EDC Solutions
Design CRFs and pipelines that capture clean, analysis-ready data using CDISC SDTM and ADaM with end-to-end traceability so you can submit to regulatory bodies with confidence. Leverage today’s best EDC systems to balance capability and cost.
Pharmacovigilance
Drug Safety at Scale
End-to-end case intake, processing, signal detection, and aggregate reporting in line with FDA, EU GVP and global expectations—supporting benefit-risk throughout development and post-authorization.
Biostatistics
Biostatistical Consulting & Full Execution
From sample size estimations and advanced statistical designs to detailed SAPs. We plan and analyze with clear objectives, estimands, and sensitivity analyses that withstand regulatory scrutiny and inform decision-making.
Medical Writing
Scientific and Medical Writing Solutions
Convert complex results into submission-ready narratives and CSRs structured to ICH E3, ensuring clarity, consistency, and auditability across modules. Present your results in powerful ways.
