Study Documents

Clinical trials require the production and maintenance of a wide range of essential documents to ensure that the trial is conducted in a rigorous and ethical manner, meets regulatory requirements, and provides robust evidence in support of the safety and efficacy of new treatments.

We provide comprehensive clinical study documentation in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and sponsor expectations.

All documents are generated in alignment with the sponsor’s templates and quality standards unless otherwise agreed, and version-controlled through secure electronic systems. We ensure timely delivery of draft and final versions, with appropriate sponsor review and approval built into document workflows. This collaborative document management process helps ensure trial readiness, transparency, regulatory compliance, and overall trial success.

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Frequently Asked Questions
We manage a wide range of study documents, including Clinical Study Reports, Protocols, Investigator’s Brochures, patient-facing documents such as Informed Consent Forms and lay summaries, clinical study reference manuals and regulatory submissions.
Yes, we provide comprehensive document preparation services. Our in-house editors/medical writing team collaborate with your team to ensure all documents are aligned with regulatory requirements and study protocols, optimizing for submission efficiency.
Our project management tools allow real-time tracking of document progress. With well-defined milestones, regular updates, and automated reminders, we ensure that deadlines are met without compromising quality. Our clinical project managers will ensure that your project meets study timelines and is conducted to rigorous standards.
Confidentiality is maintained through secure document storage solutions, controlled access, and adherence to GDPR and other relevant regulations. All team members are trained on data protection policies.
We have a dedicated team that manages submissions to regulatory authorities such as the FDA, EMA, MHRA and other global agencies. We ensure that all documentation adheres to local and international guidelines, and we follow up with authorities to expedite approvals.

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