Common Technical Documents (CTD) to ICH standards: Clinical and Nonclinical

Synergy Pharm prepares CTDs or certain sections of CTDs to ICH standards for you. We can write all or part of the clinical (clinical overview module 2.5 and clinical written and tabulated summaries module 2.7) and nonclinical modules (nonclinical overview module 2.4 and nonclinical written and tabulated summaries, module 2.6). We have particular expertise in the preparation of the pharmacokinetic and pharmacodynamic (2.5.2 and 2.7.2), clinical efficacy (2.5.3 and 2.7.3), and clinical safety parts (2.5.4 and 2.7.4), but also of the nonclinical modules (2.4.3, 2.4.4 and 2.6.4, 2.6.5 and 2.6.6).

Investigator’s Brochures

In accordance with the decree of 19 May 2006, our investigator’s brochures summarize concisely, simply, objectively and impartially all the clinical and nonclinical data relating to the trial drug, as well as the assay of the investigational medicinal product, the dosage, the method of administration, and the safety monitoring procedures.

Clinical Trial Protocols

The service we provide in assisting with the preparation of protocols ensures that your clinical trial follows a strict and clear methodology and meets ethical and good clinical practice (GCP) rules so that it has a better chance of being approved by international bodies (International Ethics Committee, IEC, or International Regulatory Board, IRB).

Clinical Trial Reports (Phases I to IV)

We prepare your clinical trial report in accordance with ICH standards and the standard format in use in your company. Our quality control, undertaken by another member of the team, guarantees precision and consistency, as well as identifying potential problems.

Literature Review Reports

At your request we undertake literature summaries and reports, detailing the methodology adopted (queries, period, inclusion and exclusion criteria, etc.), the databases consulted (Medline, unreferenced publications, etc.), and, if necessary, the exact sources (citations are identified by highlighting the exact sentence in the original document).

Evaluation Reports for Medical Device

We draft your reports for submission to the French Medical Devices and Health Technology Evaluation Committee (CNEDiMTS), or other national and international agencies (ANSM, FDA, EMA, etc.).

Investigational Medicinal Product Dossier (IMPD) for Clinical Trial Authorizations (CTA)

Our experience and know-how of IMPD dossiers is at your disposal for the purpose of obtaining authorization of your clinical trials from the competent authorities.