Clinical Trial Protocol Writing and Management

Successful clinical trials require clear protocols that reflect your study objectives and ongoing monitoring to ensure regulatory compliance. Versiti Clinical Trial Services offers customized solutions that span from drafting protocols to ongoing review and reporting.

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

Monitoring and Compliance

• Visiting the site to ensure protocol compliance
• Tracking deviations and violations
• Ensuring data integrity and participant safety

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

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