My expertise covers all aspects of study planning, from initial feasibility assessments to protocol development and resource allocation, optimizing efficiency and compliance throughout the process.

Key Components of Study Planning Support:

  1. Feasibility Assessment & Site Selection
    • Conduct in-depth feasibility analysis to evaluate study requirements, timelines, and potential challenges.
    • Identify and select optimal study sites based on infrastructure, patient population, and previous research experience.
    • Collaborate with investigators and site personnel to ensure alignment with study goals.
  2. Regulatory & Ethical Compliance
    • Ensure all study plans adhere to ICH-GCP, FDA, EMA, and other regulatory guidelines.
    • Assist in preparing and submitting documents for ethics committee and institutional review board (IRB) approvals.
    • Support compliance with local and international regulatory requirements.
  3. Protocol Development & Study Design
    • Work closely with stakeholders to draft, review, and finalize study protocols.
    • Define clear study objectives, inclusion/exclusion criteria, endpoints, and methodology.
    • Optimize study design to balance scientific rigor, operational feasibility, and cost-effectiveness.
  4. Budgeting & Resource Allocation
    • Develop detailed study budgets, including cost estimation for site payments, logistics, and contingencies.
    • Identify required resources, such as personnel, technology, and investigational products.
    • Ensure efficient financial planning to prevent budget overruns.
  5. Investigator & Site Engagement
    • Support the identification and recruitment of qualified investigators and study coordinators.
    • Conduct training sessions and provide ongoing guidance to site teams on study protocols and best practices.
    • Facilitate effective communication between sponsors, CROs, and study sites.
  6. Operational Planning & Risk Mitigation
    • Develop detailed study timelines and milestones, ensuring alignment with project goals.
    • Identify and mitigate potential risks that may impact study execution.
    • Implement contingency plans to handle unforeseen challenges, such as protocol deviations or recruitment delays.
  7. Data Management & Study Technology Support
    • Define processes for data collection, monitoring, and quality assurance.
    • Assist in selecting and implementing electronic data capture (EDC) systems and other study technologies.
    • Ensure data integrity and compliance with Good Clinical Data Management Practices (GCDMP).
  8. Logistics & Supply Chain Coordination
    • Plan and manage the supply chain for investigational products, medical devices, and laboratory materials.
    • Ensure proper handling, storage, and distribution of study materials.
    • Coordinate shipment tracking and site supply management.
  9. Communication & Stakeholder Collaboration
    • Establish clear communication channels between sponsors, CROs, investigators, and regulatory authorities.
    • Provide regular study updates to key stakeholders, ensuring alignment on project progress.
    • Address queries and facilitate issue resolution throughout the planning phase.
  10. Study Start-Up Preparation
  • Ensure all essential documents, contracts, and regulatory approvals are in place before site activation.
  • Oversee final site readiness checks and initiation procedures.
  • Provide support in site initiation visits (SIVs) and pre-study training for research teams.

By integrating these strategic planning components, I help optimize study efficiency, reduce operational risks, and accelerate the path to study initiation, ensuring a smooth transition into the execution phase.