3 Nov 2020

Medical Affairs in OPIS

The OPIS Medical Affairs Unit is team of experienced people with on average 15 years of experience and professionally qualified with scientific/medical degrees (MDs, PhDs).
Medical writers have strong scientific knowledge in most major therapeutic areas and possess a deep understanding of applicable regulations/guidelines to work internationally in close collaboration with sponsors, methodologists and operational teams
OPIS provides the following services:

  • Preparation of clinical trial documentation
  • Study synopsis and protocol development
  • Investigator Brochures
  • Informed consent forms, letter to GP, patient cards, and other patient material
  • Preparation/adaptation of clinical documentation in local language
  • Clinical Study Reports
  • Manuscripts and publications

Our Medical Affairs Unit offers medical support, in close collaboration with our biometrics team to ensure high-quality data and on-time reporting of study deliverables.
Our Medical experts are also involved in the development of scientific manuscripts and abstracts, publications and posters, literature searches/reviews as necessary to obtain background information for the elaboration of documents.

Medical Review
OPIS offers a medical-scientific oversight of research activities: the Medical Review is performed by an experienced Medical Advisor (physician) on critical study data (medical review of eligibility, concomitant medication/medical conditions, review of subject safety-related data, SAE narrative review, medical data coding and review) according to the requirements of the sponsor.

OPIS Medical Affairs team is accustomed to working within multidisciplinary project teams in compliance with regulatory requirements for quality management, in order to increase data quality and integrity of any clinical trial to the level required for valid conclusions on product performance.

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