Scion has contracted Cardiopharm with experienced ICH GCP trained pharmacists and a well equipped dispensing unit to ensure that the medication is stored and prepared according to protocol and complies to internationally accepted standards.
Fully secure facilities are available for the storage of study related documentation, equipment and supplies during the study. All documentation related to completed studies will be stored off site for at least 15 years or as required by the study sponsor at the sponsor expense. Complete records of archived materials will be maintained at the unit.
All clinical studies are conducted in accordance with South African Laws, ICH GCP guidelines, and other regulatory requirements as stipulated by the protocol and Sponsor.
All studies are conducted according to the Standard Operating Procedures of the Sponsor and/or Scion
Insurance and Indemnity for subjects recruited into the study must be provided by the study Sponsors.