Sudheendra K
Syngene Clinical Development, India
Title: Strategy for successful regulatory inspections in a Phase I human pharmacology unit
Biography
Biography: Sudheendra K
Abstract
Clinical Research Organizations (CRO) supporting the biopharmaceutical and pharmaceutical Industry have seen a paradigm shift in how regulatory inspections are conducted. The current expectations is that the CRO has to demonstrate Quality and data integrity (DI) in order to gain the trust of the regulatory investigators. Adherence to DI standards have become one of the key areas of focus during regulatory inspections. The systems used in the research industry have become more complex in terms of metadata that is being generated across the companies. Metadata that is created in a clinical trial is quite voluminous and the inspectors are aware of the possible DI issues that can arise from time-to-time. The functions such as User Access, Delete Features Data Backup Policies, Audit Trail, role of the System Administrator etc. have become the focus of attention during inspections. ALCOA principles is applicable to both paper and electronic data, thereby to ensure that the DI standards as part of Good Documentation Practices (GDP) are followed uniformly by all personnel who generate clinical trial data. To ensure that the DI standards are maintained across the life cycle of the clinical trial, Quality Systems should be integrated and omnipresent in the operation to ensure the protocol, regulations and procedures are followed. Adherence to these standards will ensure that the clinical trial data generated will meet the applicable regulatory requirements. The current climate is such that, the DI requirements shall be more demanding and a primary focal point in clinical research. The focus of this presentation will highlight how we prepared the teams on the current global requirements to ensure a successful regulatory inspection.