Services

Medical Affairs and Medical Writing


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Medical-scientific oversight of research activities

OPIS Medical Affairs Unit has been created with the aim of enhancing the medical-scientific oversight of research activities carried out across the Company, starting from the project concept sheet up to the final Integrated Clinical Statistical Report.

The Medical Affairs Unit works together with the other Company functions, such as the Biometrics Department, Clinical Operations, Pharmacovigilance and Regulatory staff with the goal of providing clients with services at the highest quality standards in the field.

The Unit includes the Medical Writing function, in charge of the preparation of all the documentation necessary for clinical trial management, such as:

  • Study protocol and synopsis
  • Investigator’s Brochure
  • Informed consent forms, letter to GP, patient card, and other patients material
  • Preparation/adaptation of clinical documentation in local language
  • Clinical Study Report
  • Manuscripts and publications

Regulatory
Trial Start-Up
Study Management and Monitoring
Data Management
SAS Programming
Statistical Analysis and Consultancy
Pharmacovigilance
Quality Assurance
Medical Affairs and Medical Writing
Preclinical and Drug Development Consultancy
Project Control
e-Clinical Platform - OPIS CLINICAL.NET