Medical and scientific advising

Medical and scientific advising

 

Clinical and Scientific expertise brought together in the form of study documentation is the very foundation of an effective clinical trial.

We have a dedicated Medical and Scientific Advising Group which is focused on medical and scientific expertise of incoming projects and on the development of documentation for clinical trials. The group consists of medical doctors and biologists, the former with tremendous background in clinical practice and the latter – in life sciences. This is a perfect combination for the development of study outlines or clinical trial documentation as it enables at the same time to consider the real needs of clinical practitioners and to frame up adequate scientific objectives. Our specialists have a wealth of experience in preparation, translation and adaptation of trial documentation. Their expertise assures documents fully compliant with Good Clinical Practice (GCP) and all client and regulatory requirements, enabling a speedy and efficient trial.

Our specialists from Medical and Scientific Advising Group collaborate also with Sponsors' Medical Departments. They participate in preparation of original study articles and review articles for local and for the international peer-review journals, in developing promotional materials for patients and for medical specialists.

Our services include:

  • medical and scientific expertise of incoming projects
  • development of study outlines and protocol synopses
  • writing of clinical trial protocols and protocol amendments
  • preparation/adaptation of informed consent forms, in accordance with local regulatory and ethics requirements
  • case report forms design (paper and electronic)
  • development of specific questionnaires and patient/doctor diaries
  • writing investigator brochure and updates
  • clinical study report preparation
  • translation of client study documents into local languages
  • preparation of scientific and medical articles for local or international peer-review journals
  • proof reading of promotional materials
  • preparation of slide sets and training materials
  • interpretation of international training modules into local languages
  • scientific annotation of medical literature
  • creation of patient oriented materials