Clinical Study Submission

 

I provide end-to-end support for the submission of clinical trials, ensuring the accurate preparation, organization, and timely delivery of all required documentation to regulatory authorities, ethics committees, and institutional review boards (IRBs). My expertise covers global regulatory requirements, ensuring compliance with guidelines set by the FDA, EMA, MHRA, Health Canada, PMDA, and other health authorities.

Key Components of Clinical Study Submission Support:

1. Regulatory Strategy & Submission Planning

  • Develop a regulatory submission strategy aligned with study timelines and jurisdiction-specific requirements.
  • Identify and compile the essential documents required for submission based on ICH-GCP, FDA, EMA, and local regulatory guidelines.
  • Establish clear timelines to ensure on-time study approval and initiation.

2. Preparation & Compilation of Regulatory Documents

  • Prepare and compile submission-ready documents, including:
    • Clinical Trial Application (CTA) and Investigational New Drug (IND) application
    • Informed Consent Forms (ICF) and participant information sheets
    • Study Protocols and Amendments
    • Investigator’s Brochure (IB)
    • Case Report Forms (CRFs)
    • Regulatory correspondence and ethics approval requests
  • Ensure all documents comply with regulatory format and submission standards.

3. Interaction with Regulatory Authorities & Ethics Committees

  • Facilitate communication with health authorities, IRBs, and ethics committees.
  • Respond to regulatory queries, deficiencies, and requests for additional information.
  • Support the preparation and submission of responses to FDA, EMA, MHRA, and other agency inquiries.

4. Electronic & Paper Submission Management

  • Ensure correct formatting and submission via electronic submission gateways, including:
    • FDA Electronic Submissions Gateway (ESG)
    • EMA EudraCT and CTIS for EU Clinical Trials Regulation (CTR)
    • eCTD (Electronic Common Technical Document) format compliance
    • Local regulatory authority portals (e.g., Health Canada, PMDA, TGA, MHRA, etc.)
  • Manage paper-based submissions where required and ensure proper documentation handling.

5. Investigational New Drug (IND) & Clinical Trial Application (CTA) Submissions

  • Prepare IND submissions for FDA approval of investigational drugs.
  • Ensure compliance with CTA requirements for international regulatory bodies.
  • Submit and track amendments, annual reports, and safety updates.

6. Risk Mitigation & Compliance Assurance

  • Ensure compliance with Good Clinical Practice (GCP), Good Documentation Practices (GDP), and Good Submission Practices (GSubP).
  • Perform pre-submission quality control (QC) checks to identify potential deficiencies.
  • Conduct gap analysis to ensure submission documents align with regulatory expectations.

7. Post-Submission Follow-Up & Regulatory Maintenance

  • Track submission status and ensure timely follow-up with regulatory agencies.
  • Manage study updates, protocol amendments, and safety reporting obligations.
  • Maintain regulatory records and correspondence for audit readiness.

8. Safety Reporting & Adverse Event Submissions

  • Ensure timely submission of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and Development Safety Update Reports (DSURs).
  • Coordinate safety reporting requirements across multiple jurisdictions.
  • Collaborate with pharmacovigilance teams to ensure regulatory compliance.

9. Study Registration & Public Disclosure

  • Register clinical studies on public databases such as ClinicalTrials.gov, EudraCT, and WHO ICTRP.
  • Manage results disclosure and transparency requirements post-study completion.
  • Ensure compliance with trial registry requirements for sponsors and regulatory bodies.

10. Final Submission Archiving & Regulatory Inspection Readiness

  • Maintain organized submission records for regulatory inspections and audits.
  • Ensure proper archiving of submission documents in accordance with ICH E6(R2) guidelines.
  • Support inspection preparedness by ensuring all regulatory documentation is readily accessible.

By leveraging strategic planning, regulatory expertise, and precise documentation management, I help ensure that clinical trial submissions meet regulatory standards, minimize approval delays, and facilitate a smooth study initiation process.