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A focus on Synergy Pharm: specialists in clinical and regulatory documentation

Synergy Pharm specialist of Clinical and Regulatory Documentation

July 4, 2023

What do our medical writers do and why do they do it?

Before the clinical study

Our team provides medical writing assistance for drafting the many documents required for Clinical Trial Authorization (CTA) dossiers including:

  • Investigational Medicine Product Dossiers (IMPDs), containing information on the quality of the product(s) to be used during the clinical trial (study product, reference product, placebo), their manufacture, the controls carried out, and the data previously obtained in nonclinical and clinical studies where applicable.
  • Investigator Brochures (IBs),containing the information necessary for investigators and other healthcare professionals involved in conducting the clinical trial (summary of all preclinical and clinical studies that have been conducted with the study product, and information on the doses to be administered, frequency and method of administration, etc.).
  • Scientific Advice Briefing Documentation, containing questions and the answers of the applicant for preparing the clinical study protocol. The Committee for Human Medicinal Products (CHMP) reviews the documentation and submits advice to the applicant.
  • Clinical Study Protocols (CSPs), containing a description of the basis of the clinical trial (context, hypotheses, objectives, etc.) and the information necessary for the proper conduct of the clinical trial (subject inclusion and exclusion criteria, trial duration, number of visits, schedule, products used with their dose and frequency of administration, information collected, method for evaluating the efficacy and safety of the products evaluated, etc.). A synopsis or summary of the protocol is also required.
  • Newsletters to participants, containing the information necessary to enable potential participants to make an informed decision on whether to participate in the clinical trial (including the objectives and conduct of the study, participant involvement, types of products used, possible risks, expected benefits, etc.).
  • Informed Consent Forms for recording the patient’s consent to participate in the clinical trial after receiving all the necessary information.
  • Pediatric Investigation Plans (PIPs),required for clinical trials concerning products intended for children.

After the clinical study

Our medical writing agency takes care of writing all the essential documents required to obtain marketing authorization for medicines and medical devices including:

How does our medical writing company work to meet all the needs of our clients?

Confidentiality: We sign confidentiality agreements for all our projects.

Critical review of documentation and data: compiling regulatory dossiers gives our experienced team an ideal opportunity to critically review the scientific documents associated with the projects of our clients, allowing us to identify any potential errors in the data or in their analysis at the outset, avoiding any problems further down the line.

Quality control: All our documents are prepared to International Council for Harmonization (ICH) standards and in accordance with our standard operating procedures (SOPs): the quality of all our projects is verified by another medical writer in our team at each stage of the writing process.