Why Drug Discovery Equations are Going Wrong? Reaping the Benefits Why HCL’s CRO Services? “It's great working with you. Please extend a big thank you to all HCL employees providing services to the project. It's a great achievement and we are looking forward to working with you to make the project a great success story.” - Director “It’s a great professional and human opportunity to work with HCL! Thank you for all your support.” - Italy Process Steward “It gives me great pleasure to acknowledge that it was a satisfying experience to work with the MW, Clinops & DM teams of HCL technologies. HCL not only has an outstanding medical writing group but also has an equally dedicated and passionately driven clinical operations and data management team. An absolute pleasure to interact & work with HCL Technologies Ltd.” - Deputy General Manager, Medical Services IT Specialist With In-House CRO from MDs, Biostaticians, Data Managers to Research Associates Savings Offered in Operational Costs 40 % Per Year Savings on each Study $3 Mn Proven Track Record With Over 150 Clinical Trials Years 12 + HCL’s Life-Sciences METHODOLOGY HCL’s CRO Services Only Team of Experts Partnerships for Quicker Approvals and Regulatory Compliance Quick Setup and Localization of Trial Efforts Multi-Platform Data Management Expertise Six Sigma based Quality Control Procedures Complex Global Regulatory and Compliance Guidelines Hard to Maintain Data Quality & Sanity Burgeoning Clinical Trial Costs Capital Intensive Clinical Research Practice Retire & Extend Discover Optimize Pre-Clinical Planning Study Management Closeout Implementation Market Research Publishing & Submission MMA and NDA support Coordinate Launch Patient Support Program GMP (Good Manufacturing Practice) New Market Approvals Quality Assurance CAPA Start-up Quality Control Technology Transfer & Support eCTD Support Drug Development Regulatory Approval Quality Management Compete for generics Prepare Drug Extensions Product Launch Drug Discovery Remedying Clinical Research Woes HCL - Key Focus Areas HCL creates ‘shared services’ across 7 locations for a Global Pharma client, to bring about process standardization and transformation. Few Highlights of our achievements in Pharmaceutical and Medical Device Services area: Commercial Production Clinical Data Management Medical Writing Drug Safety Services Regulatory Publishing and Submissions Risk-Based Monitoring Core Offerings For a large Asian Pharmaceutical Company