Site Management

  • Ensuring, coordinating and supporting the different phases of a study project
  • Operative support of clinical studies in accordance with the protocol, corresponding SOPs, current ICH-GCP guidelines and local law
  • Preparation and creation of patient information and informed consents
  • Submissions to national and international ethics committees and regulatory authorities
  • Maintenance of required documentation archives of sites and sponsor
  • Overview of maintenance and distribution of study specific equipment
  • Performing evaluation, initiation, monitoring and close-out visits
  • Supporting the sponsor during documentation of adverse reactions and database maintenance
  • Maintenance of study specific sponsor systems and their access permissions
  • Planning, Organisation and conduct of investigator meetings and workshops
  • Support in contractual matters and payments
  • Support of sites and sponsor during audits and inspections