CSR writing and verification
How to present data from clinical trials – the Clinical Study Report
The Clinical Study Report (CSR) is an integrated, compelling and well-structured document gathering data from an individual clinical study. It is the record of all essential information concerning the study, including the study design and its rationale, description of the study population, treatments, study variables and their assessment, statistical issues, and safety – adverse events – evaluation.
In the spirit of global harmonization of the rules governing the development of medicinal products, detailed guidelines have been created describing how to present the results from the clinical trials in the CSR. They are gathered in the International Council for Harmonisation (ICH) guideline ICH E3 Structure and content of clinical study reports.
Preparing the document in accordance to those guidelines, with the presentation of all the necessary appendices, minimizes the risk of questions and streamlines the review of the study by Competent Authorities.
The medical writers at SciencePharma are experienced in preparing reports from clinical trials of different phases.
Data gathering, management and analysis
But let us take a step back… In order to prepare the CSR, it is first necessary to properly gather all the data from the study, arrange them in the data sets for the statistical analysis, and run the analyses with the use of the appropriate statistical approach.
Whether you prefer to use the traditional approach and gather the data in the written CRF, or the electronic CRF (eCRF) is used in the study, we can assist you in the data management and the design of the database. We also cooperate with experienced statisticians, who can advise you on the selection of statistical tests, prepare the Statistical Analysis Plan (SAP), run the analyses and document them in the statistical report.
So, if everything is meticulously explained in the guidelines, one could wonder why there is a need for assistance in the preparation of the reports from clinical studies.
From our experience, even in the case of the most detailed CSRs, many Competent Authorities still raise questions related to these documents during the Marketing Authorization Applications (MAA). As these reports form part of the registration dossier, it is vital that they contain all the necessary information that the Competent Authority may search for during the assessment – not only the factual data, but also their explanation and interpretation.
Discussing the clinical study outcomes already in the CSR greatly facilitates the preparation of the registration dossier submitted with the MAA and the subsequent discussion with the Competent Authority.
At SciencePharma we combine our experience in Regulatory Affairs and Clinical Trials, to produce high quality reports, anticipating possible questions to the studies, and including the responses already in the reports.
At SciencePharma offer CSR preparation services involving:
- Preparation or verification of clinical, bioanalytical, statistical or integrated study report(s) in compliance with ICH E3 guideline, as well as ISO standard and relevant law in case of clinical investigation report for medical devices.
- Providing a full range of data management services, including database design and its validation, generation and entering data into the database, quality control, MedDRA coding, query generation and database close-out.
Our medical writers are experienced not only in the preparation of documents related to clinical trials, but also in the preparation of registration dossiers and discussions with the Competent Authorities during the process of obtaining Marketing Authorization (MA).
All this experience is used to prepare the CSRs in the way to anticipate any potential questions or allegations from the Competent Authorities and to facilitate the discussion. Minimizing the regulatory risk at an early stage largely contributes to meeting the project timelines and budget.
If you are looking for a partner to help you with the management of the data from your clinical trial, or you are seeking experienced medical writers to prepare or verify the reports from your studies, do not hesitate to contact us.
You may also wish to check other clinical trial services that we provide.