Cro Services
End-to-End Biometrics & Clinical Data Services
Biostatistics
Protocol-embedded Statistical Analysis Plans (SAPs), sample size & power calculations, estimand framework (ICH E9(R1)), interim analysis design, DSMB report, & CSR statistical sections.
Data Management
EDC build and validation (Medidata Rave, REDCap, Oracle InForm), CRF design, Data Validation Specifications (DVS), SAE reconciliation, medical coding (MedDRA / WHO Drug), and database lock support.
Clinical Programming
End-to-end clinical trial support from Phase I first-in-human studies through Phase IV post-marketing trials spanning eCRF setup, site activation, protocol deviation tracking & randomization (IXRS/IVRS).
Statistical Programming
SAS® and R-based programming of Tables, Listings & Figures (TLFs). CDISC SDTM/ADaM dataset creation, define.xml generation, Pinnacle 21 validation, and submission-ready deliverables for NDA/BLA/ANDA packages.
Regulatory Affairs
Regulatory Affairs includes eCTD submission planning and preparation, IND/NDA/BLA module authoring, DCGI dossier support, FDA Pre-IND/Pre-NDA meeting preparation, and ICH-GCP audit readiness.
Medical Writing
Medical Writing includes Clinical Study Reports (CSRs per ICH E3), Statistical Analysis Plans, Investigator's Brochures (IBs), protocols, informed consent forms (ICFs), briefing documents, and product labels.