Clinical Trial Protocol Writing and Management

Guide your research with expert-led medical writing and management of your trial protocol.

Medical Writing Tailored to your Study

 

Our medical writers and clinical subject matter experts partner with your team to develop clear, accurate, and submission-ready clinical and regulatory documentation. We support the full documentation lifecycle—from early study planning through data analysis and reporting—including clinical study protocols, informed consent forms (ICFs), standard operating procedures (SOPs), clinical study reports (CSRs), investigator brochures (IBs), and other essential trial documents. 

Our regulatory writing team also provides strategic authoring and preparation of IND, NDA, IDE, and PMA submissions to help ensure alignment with global health authority expectations and streamline regulatory review.

What is Clinical Trial Protocol Management?

Regulatory & Ethical Review

  • Submitting the protocol to Institutional Review Boards (IRBs) or Ethics Committees
  • Ensuring compliance with regulatory authorities (such as FDA, EMA, and others)
  • Implementing feedback

Protocol Implementation

  • Training study staff on protocol procedures
  • Setting up trial sites and systems (such as EDC, randomization tools, and others)
  • Ensuring all stakeholder execution

Amendment Management

  • Updating the protocol when changes are needed (e.g., due to safety findings or recruitment issues)
  • Submitting amendments for regulatory and ethical approval
  • Communicating changes to all stakeholders

Documentation & Version Control

  • Maintaining a version-controlled master protocol document
  • Archiving all protocol-related communications and approvals

Audit & Inspection Readiness

  • Ensuring documentation of all protocol activities
  • Preparing for audits by sponsors or regulatory agencies

What Are Clinical Trial Protocol Reporting Services?

Clinical trial protocol reporting services ensure transparency, regulatory compliance, and scientific integrity throughout the study.Versiti protocol reporting services include:

Initial Protocol Submission

  • Submission to regulatory authorities and ethics committees
  • Includes study objectives, design, methodology, and safety measures

Trial Registration

  • Public registration of the trial (including on ClinicalTrials.gov)
  • Promotes transparency and allows public access to the study information.

Ongoing Reporting

  • Protocol Deviations/Violations: Documentation and explanation of any divergences from the approved protocol
  • Amendments: Reporting and approval of any changes to the protocol, including rationale and impact on the study
  • Safety Reports: Regular updates on adverse events and safety monitoring outcomes
  • Interim Reports: Ongoing updates to sponsors, ethics boards, or regulators on trial progress, recruitment, and safety
  • Final Protocol Report: Comprehensive summary of trial execution, including any deviations or amendments

Publication & Transparency

  • Reporting of trial results in peer-reviewed journals or public databases
  • Ensures alignment between reported outcomes and original protocol objectives
Connect with Our Protocol Experts
 
Data & Project Management
At Versiti Clinical Trial Services, we provide dedicated project and data management teams to support your clinical trials from start to finish.
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Study Design & Site Selection Services
Optimize your Clinical Trial Study Design with expert site selection and monitoring services tailored to ensure trial success from start to finish.
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Clinical Trial Management
From protocol management to regulatory compliance, our clinical trial management services ensure seamless, end-to-end study support you can rely on.
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Vendor & Supplier Management

Coordination of vendors to ensure quality, compliance, and cost-efficiency across all trial elements.

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