Clinical Trial Supply

We offer our clients regulatory consulting and logistics management of clinical trials, a complementary service to the activities performed by CROs for clinical research.

  • Preparation of the Investigational Medicinal Product Dossier (IMPD).
  • Preparation of Investigator’s Brochure (IB).
  • Preparation of clinical trials applications to be submitted to Institutional Review Board / Independent Ethics Committee (IRB/IEC) or to the Competent Authorities.
  • Texts design for the labeling of Investigational Medicinal Products (IMP) according to Annex 13 of GMP.
  • Design of blinding/masking strategies for IMP.
  • Manufacturing of IMP, including placebo.
  • Labeling and packaging (primary and secondary) of IMP.
  • Storage of IMP from -80ºC to room temperature.
  • Distribution of IMP among clinical trial sites.
  • Management of the return, accountability and destruction of medication used in clinical trials.

 

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