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  • Provision of qualified Study Coordinators
  • Recommendation and selection of investigators
  • Identification of Sites and completion of Project Feasibility
  • Completion and collection of documentation required for clinical trials
  • Adaptation of clinical trial documentation as per local requirements
  • Arrangement of execution of clinical trial agreements
  • Patient referral, enrolment, retention and follow-up
  • Submission of documents to Competent Authorities for obtainment of required approvals and ongoing communication throughout the studies
  • Assurance of quality of research centers as per ICH GCP, local legislation and regulatory requirements
  • Selection of CRAs and sub-contracted CROs, if required
  • Provision of selected vendors (microbiology laboratories, pathology centers, radiology facilities, translation agencies, etc.), if required
  • Training study personel for ICH GCP (ProAktis is an authorized ICH GCP training provider)