Sharmeen Reza
Cytel Statistical Software and Services Private Limited, India
Title: Quality control in statistical programming under GCP
Biography
Biography: Sharmeen Reza
Abstract
Statistical programming to support clinical research and data analysis is vital in the drug discovery process. GCP is a prerequisite for any submission to regulatory authorities for drug approval and licensing. Quality control (QC) comes with different measures and tools following Standard Operating Procedures (SOPs), established by sponsor companies and/or Contract Research Organizations (CROs). The SOPs are mainly based on GCP guidelines. This presentation exhibits brief overview of QC in overall clinical trials, with focus on QC done right for statistical programming in a R&D environment. It gives relevant definitions, processes followed, reasons for QC, challenges faced, deviations and expectations. The topic also describes roles, expertise, requirements, documentation and responsibilities involved. Given a drug’s prospects, the impact of a solid QC process outweighs resource investments. Since quality is a key performance indicator and helps to select preferred partnership, pharmaceutical companies highly value CRO capabilities in conducting QC.