Safety & Compliance
The Life science industry has to constantly abide by new and changing initiatives, guidelines and regulations imposed by global regulatory agencies. With patient safety being a major priority, continuous scrutiny and subsequent changes in the regulations is frequent. Regulatory compliance is also a major factor in enhancing the brand value to the customers.
Wipro focuses on a proactive risk management approach to assure drug safety and related data management. This is brought about by sophisticated data management services including:
- Integration of Safety Reporting and Safety Analysis Systems with the Clinical Data Management and Clinical Trial Management Systems
- Consolidating adverse event (AE) data to meet data agility requirements
- Pharmacovigilance
- Drug information services
- Product complaint management
- Adverse Drug Event (ADE) monitoring and reporting