QC, Review and Redaction

We can provide an independent Quality Review that involves a thorough assessment of your regulatory documents. Our review can be conducted in advance of or in parallel with your internal peer review and is complementary to those of your statistical, clinical and regulatory teams.

Our Quality Reviews are conducted according to in-house standard processes, although these can be tailored to your requirements. We can also provide a comprehensive report identifying key findings.

We work closely with our clients' project teams and understand the need to meet the timelines dictated by regulatory deadlines. We maintain knowledge of current guidelines and regulations for industry-specific documents including ICH guidance, Code of Federal Regulations and other regulatory requirements.

Clinical trial transparency obligations are foundational to a Sponsor’s commitment to patient centricity. Achieving compliance with diverse and evolving global regulations is challenging and requires:

  • A thorough understanding of how the regulations impact individual clinical studies and company processes.
  • The ability to apply this knowledge to create disclosure documents that are ‘right first time’.
  • Monitoring the progress of all disclosure documents across your clinical trial portfolio.

We provide a redacting and/or anonymising service to meet regulatory requirements that is responsive to regulatory timelines

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Frequently Asked Questions
International regulations such as the EMA’s Policy 0070 require certain regulatory documents to be made publicly available. To protect individuals’ privacy and safeguard commercially confidential information, these documents must be anonymised before publication. Anonymisation is a critical and technically complex process that ensures sensitive data is protected while maintaining data integrity and meeting compliance standards.
Anonymisation planning begins early in the document lifecycle. Our medical writers work closely with clients from the outset to identify the most appropriate anonymisation strategies balancing regulatory compliance, data integrity, and scientific clarity. By establishing this approach early, we aim to minimise the need for retrospective changes. Each anonymised document also undergoes a rigorous, independent quality review to ensure alignment with the latest regulatory requirements.
At Niche, all documents whether anonymised or not undergo a thorough internal review, and a formal Quality Check when required. These reviews are conducted by experienced, independent medical writers to ensure alignment with current guidelines, regulatory requirements, and the client’s brief. This includes verifying adherence to any pre-agreed anonymisation rules and client-specific requests, ensuring every document meets the highest standards of accuracy and compliance.

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