Can a CRO help prepare documentation for the Bioethics Committee?
Yes. At Biostat®, we often take over this part of the process because this is where delays most frequently occur. Different Bioethics Committees require different forms, attachments and declarations. If documentation is incomplete or inconsistent — the committee usually returns it for correction, delaying study initiation by weeks.
As a CRO, we prepare the full submission package, including:
• the Bioethics Committee application (tailored to the specific committee’s templates),
• the study protocol and a lay-language summary,
• patient information and informed consent forms with clear descriptions of risks, benefits and data processing,
• CVs of investigators, site capability declarations,
• sponsor insurance policy (if required),
• cover letter and full set of attachments required by both the Committee and URPL (if applicable).
We also manage communication with the committee: submitting documents, addressing formal deficiencies, responding to questions, tracking meeting dates and verifying the final opinion.
With our support you gain:
• correct study classification (clinical trial, observational study, device investigation, medical experiment),
• a complete, submission-ready documentation package,
• regulatory advice for medicinal products and devices,
• documentation aligned with MDR and GCP,
• faster study start with fewer corrections and delays.
If you are unsure how to classify your project, simply send us a short description: study objective → type of product → planned patient/data activities.
We prepare the recommended regulatory pathway and a list of required documents — including a classification report if needed.
