Clinical Trial Design and Planning
Transforming Concepts into Compliant, Effective Clinical Trials
Strategic Clinical Trial Design for Successful Research Outcomes
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.
Expert-Led, Regulatory-Compliant Trial Designs
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.
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.
Why Choose
FDAMap Clinical?
Partner with a Trusted CRO for Regulatory Excellence and Trial Success
Efficiency and Precision
From protocol development to clinical trial site selection, our services are designed to streamline clinical trials process while maintaining the highest standards of quality.
Tailored Solutions
We customize our approach to your trial’s specific needs, therapeutic area, and target population.
Regulatory Expertise
Our team brings decades of experience in regulatory compliance to ensure your trial meets all requirements.