Regulatory requirements around pharmacovigilance are continuously evolving. It is becoming imperative to minimize risks associated with carrying out complex clinical trials involving huge budgets running into more than a decade. Hence, it is important for Life Sciences organizations to implement an effective pharmacovigilance system in order to protect their patients from the adverse events. This will also help these organizations to increase the success of the clinical trials.
Why Pharmacovigilance Systems Strategy?
- Aligning IT initiative with business goals
- Investing in pharmacovigilance systems which conform to regulatory requirements
- Cultivating the IT/business partnership
- Improving IT operations/systems performance
How Can Navitas Help?
Navitas with its strong domain expertise understands diverse Pharmacovigilance systems and processes, and has deep understanding of industry requirements – to provide business needs assessment services, process design services, systems configuration and development services. Navitas is committed to deliver system strategy services that address the entire PV ecosystem including PV team of sponsors, outsourced CROs, MAH, Affiliates and regulatory authorities. Services offered include:
- As is system and process understanding - Pharmacovigilance function
- Identification of regulatory compliance needs e.g. 21CFRpart11, IDMP, E2B R3 etc.
- PV Systems integration advisory services
- PV systems implementation and validation best practices e.g. GAMP
- Evaluate PV systems
- Pharmacovigilance IT strategy and roadmap
- Evaluation of Pharmacovigilance Systems
- Pharmacovigilance Systems Strategy and Roadmap