Quality Assurance

Quality Management System

Our Quality Management System (QMS) comprises of the Quality Policy, Quality Manual, SOPs and Templates. Under kQua™, our proprietary quality framework, we have a comprehensive suite of 140+ SOPs, Policies and Templates that we will utilize to conduct the studies in a GCP compliant manner. These are further strengthened by a defined framework of Sponsor Project Service Level Agreements (SLAs) and Quality Check Points for each project to ensure rigorous quality assurance. If required, we are flexible to use the Sponsor SOPs. We have also identified Six Sigma as a corporate initiative for 2011 and currently have 1 certified Master Black Belt, 2 Green Belts and over 40 Yellow Belts.

Clinical Operations QA

Our Clinical Operations quality process starts with a Study Specific Audit Plan and a robust Site Initiation program consisting of detailed ICH-GCP training as well as Protocol training of all site staff. Here, relevant processes related to taking Informed Consent, maintaining Site Master Files, filing Case Report Forms, IP Storage and Handling, AE/SAE Reporting etc. are explained in great detail to the site staff and an actual demonstration is provided where possible. The Quality Manager keeps a Protocol Deviations, ICD Deviations as well as Issue Action Log for each project highlighting any and all quality issues in the project, conducts an in-depth root cause analysis of the same, develops a Corrective and Preventive action plan (CAPA) and trains monitoring and site teams on the same. Apart from standard monitoring visits we ensure routine and for cause site audits and reporting at ~ 20% of sites at anytime during the conduct of a trial. Detailed Site Audit reports highlighting GCP and quality issues are forwarded to senior management for review and a comprehensive resolution plan is generated post root cause analysis and solution brainstorming.

CDM & Stats QA

On the Data Management front, there are defined quality checkpoints at each study milestone from Data Management Plan (DMP) and Quality Plan (QP) development to Functional Specifications (FS) and User Requirement Specifications (URS) development to Database Design, Double Data Entry, Discrepancy Management, SAE Reconciliation to Data and Safety Review, Database Lock and Data Extraction.

Internal Audit Programs

The Statistical Analysis and Medical Writing processes have self-review, peer review, program validations and final approval by an Expert Panel as processes build in to facilitate quality assurance.

We further have a comprehensive Internal Audit program that covers all activities/processes for each department wherein planned as well as surprise audits are conducted on a monthly basis and a detailed quality report gets generated followed by a Non Conformances closelooping plan. This is supplemented by quarterly Management Review Meetings as well as Annual Surveillance Audits.