Statistical consulting for clinical trials including statistical analysis plans, randomization schedules, regulatory submissions, integrated analyses, and publication support. Services encompass SAP development, CSR preparation, TFL shells, ISS/ISE integrated analysis, FDA regulatory interactions, and ad hoc analyses to support regulatory and publication outcomes.

End-to-end clinical data management for bio-pharma sponsors covering database design, data entry and cleaning, external data reconciliation, SAE reconciliation, dictionary coding, and database lock. The service encompasses eCRF design, edit check specification, UAT, MedDRA/WHO Drug coding, and DMC support to ensure submission-ready datasets and regulatory compliance throughout the clinical trial lifecycle.

Regulatory medical writing for bio-pharma clients including clinical protocols, CSRs, pharmacovigilance reports, CTDs, NDAs, investigator brochures, and literature reviews. Services include quality control and review processes before regulatory submission to ensure compliance with FDA and EMA standards across all clinical development and post-market documentation.

Clinical statistical programming delivering SDTM/ADaM datasets, TLFs, submission-ready packages, and safety surveillance reporting for bio-pharma studies. The service includes SDTM and ADaM dataset creation, define.xml documentation, ISS/ISE integrated analyses, DMC and interim analysis support, DSUR/PSUR reporting, and sample size calculations aligned with regulatory requirements.