Vac3 Clinical Services

SERVICES: Phase IV Clinical Studies Post Authorization Efficacy Study Post Authorization Safety Study PMS Investigator Initiated Study Observational Study Scientific and Regulatory Writing Protocols IB CRF CSR ICF CTDs IMPD IND Dossier NDA’s Safety Narrative Preparation and submission of DSUR/PSUR Meta Analysis of Multiple Clinical Studies SOPs Benefit Risk Assessment Reports Risk Management Plans Patient Diaries DSMB Charter Medical Marketing Manuscript writing Conference abstracts / Presentations Content, design, and layout of scientific posters Journal selection / submission Editorial Writing Product/Drug Monographs Patient information leaflets SmPCs Physician education material Pharma Sales force training manuals / Promotional Inputs CME Presentation Newsletters / Visual Aids Book Chapters Copy Editing, Proofreading and Formatting Literature Review Research to support product launch activities Literature searches to update existing documents Training CRA/CRC Investigators ICH GCP Pharmaceutical Sales Executives Site Management Services Site Feasibility, selection and recruitment Manage and train site personal Maintain contact with sites and regular site status Collaborate with IEC Expedite adverse event reporting