Clinical Trial Design and Planning

Transforming Concepts into Compliant, Effective Clinical Trials

The success of a research program begins with its clinical trial design. Poor planning or trial design can lead to costly issues and errors that no statistical methods can fix. At FDAMap Clinical, we help you maximize your research investment by providing expert clinical trial design services.

With over two decades of experience running successful clinical trials across various therapeutic areas, we craft customized trial designs that align seamlessly with your research objectives. Our expertise ensures your trial is strategically designed, scientifically sound, and fully compliant with the clinical trial guidance and regulations of the FDA, EMA, and other regulatory bodies.

Why Choose FDAMap Clinical?

Partner with a Trusted CRO for Regulatory Excellence and Trial Success

Efficiency & Precision

Decades of experience ensuring compliance with FDA, EMA, and international guidelines.

Tailored Solutions

Custom-designed trial strategies to fit your study’s unique requirements.

Efficiency & Precision

Streamlined trial processes from protocol development to site selection.

Patient-Centric Approach

Prioritizing participant safety and engagement to enhance study outcomes.

Our Comprehensive Clinical Trial Design and

Planning Services

We offer a complete range of services tailored to meet your unique needs:

Protocol and Informed Consent Form (ICF) Development

Site Selection and Feasibility Studies

Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Approval

Clinical Trial Risk Assessment and Mitigation Plans

Ready to Begin?

Let us help you design and plan your clinical trial with confidence.

Ensure seamless trial execution with expert protocol development, site selection, regulatory approvals, and risk mitigation strategies tailored to your study needs.

Protocol and Informed Consent Form (ICF) Development

  • Creation of detailed, compliant clinical trial protocols that meet regulatory standards while prioritizing patient safety and trial efficiency.
  • Development and review of clear, patient-centric ICFs to ensure participants fully understand the trial and its potential risks.
  • Guidance on clinical trial protocol amendments to address emerging trial needs or regulatory feedback.

Site Selection and Feasibility Studies


  • Comprehensive feasibility assessments to evaluate trial viability based on your therapeutic area and target population.
  • Identification and selection of optimal trial sites, focusing on patient recruitment potential, site expertise, and past performance.

Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Approval


  • Preparation and submission of all required documents to secure timely IRB/IEC approval.
  • Expert consultation to navigate ethical considerations and address potential regulatory hurdles.

Clinical Trial Risk Assessment and Mitigation Plans

  • Identification of potential risks at every stage of your clinical trial.
  • Development of robust risk mitigation strategies to ensure trial continuity and regulatory compliance.
  • Ongoing monitoring and adaptation of risk plans as your trial progresses.