Before the Clinical Study

The Investigational Medicinal Product Dossier (IMPD) for Clinical Trial Authorization (CTA)

Our experience and know-how of Investigational Medicinal Product Dossiers (IMPDs) is at your disposal. Our medical writing team will ensure that your IMPD contains all of the information needed to obtain authorization for your clinical trials from the competent authorities.

Investigator’s Brochures (IBs)

Our medical writers will prepare your Investigator’s Brochure (IB) in accordance with the decree of 19 May 2006. We will ensure that your IB provides a concise, simple, objective and impartial summary of all the clinical and nonclinical data relating to your trial drug, and that your IB includes all of the information required on the dosage, regimen, and methods of administration of your investigational medicinal product, and on safety monitoring procedures.

Clinical Study Protocols

Our clinical study protocol writing service will ensure that your clinical trial has a strict and clear methodology to follow and meets ethical and good clinical practice (GCP) standards so that it has a better chance of being approved by international bodies such as the International Ethics Committee (IEC) or the International Regulatory Board (IRB).

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