PV Strategy and Roadmap

• Provide interim PV support for early phase companies
• Establish and maintain PV interfaces with other functions

Case management (ICSR processing and reporting)

• Provide expertise on workflow builds, case processing standards, templates, conventions, and process improvements
• Select, train, and oversee case processing vendor
• Implement electronic data capture tools

Clinical study execution (Study doc review)

• Support PV related study activities such as facilitation of study documents (e.g., IB, ICF, Protocol, and Safety Management Plan)
• Facilitate safety review committees

Study maintenance support (Queries, Site training)

• Set up of SAE collection mechanism, query management, SAE reconciliation, and regulatory reporting
• Support and oversight of Trial Master File (TMF) documentation related to PV