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Your partner in new drug R&D
Taking a blood sample

Clinical development services

Bio-Assistance can perform for you any of the following activities:

  • Design of clinical development programs
  • Identification, selection and supervision of Clinical Research Organization:
    • Definition of scope of work
    • Negotiation of quality contracts
    • Verification of qualifications of a CRO
    • Contract management to assure compliance with Good Clinical Practice (GCP) guidelines, timelines and budget
    • Review of progress and monitoring reports to identify potential problems
    • Auditing
    • Review of clinical protocols and reports
  • Preparation of regulatory documentation:
    • Investigator’s brochure
    • Patient Informed Consent Form
    • Information package for Institutional Review Board (IRB) / Institutional Ethics Committee (IEC) approval
    • IND and CTA compiling
  • Pre-IND/CTA meetings with regulatory agencies
  • Clinical trial supply handling
  • Clinical site management to ensure compliance with the ICH GCP guidelines
  • Reporting to IRB/IEC, regulatory agencies, and sponsors