Vaibhav Waghmare Email and Phone Number

Obtain and maintain CSR regulatory documentation in accordance with Pharmanet/i3 or Sponsor SOPs, GCP, and ICH guidelines.Insert tables, listings, and figures into the CSR body or appendices as needed.Interact directly with study teams regarding accessing necessary documentation for CSR appendices and ensure successful completion of the appendices according to client requirements. Provide quality-control (QC) check of CSR shell and drafts, formatting for compliance with Pharmanet/i3 or client-specific formats and providing feedback on needed changes to writers; this may involve copy-editing level detail or document construction level detail.Confirm that formatting, numbering, and styles and all contents of a published document are in accordance with ICH/FDA guidelines to assure document is submission ready, where applicable. Perform pagination, bookmarking, and/or hyperlinking in the creation of a PDF version of a final CSR, or according to client specifications, and provide final document electronically as PDF and/or MS Word files to client.Provide hardcopy printing services of final documents either directly or through oversight of external vendor, according to client agreements. Archive hardcopy and electronic files of the final CSR or summary document as appropriate. Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance. Develop and provide training to team members on template usage.

Publishing Clinical Documents like Protocol, Protocol Amendments, Statistical Analysis Plan, Investigator’s Brochure, Clinical Study Reports, Literature References, TLFs for submission to the Regulatory Agencies.Indexing, TOC creation and DCF Hyperlinking for CRF pre-publishing activitiesPublishing of patient CRFs for paper and EDC StudiesPublishing of Sample CRFs (Master and Draft)Performing Peer Review for processed documents