FDAMAP Clinical Services

Terms of Use


Introduction

Welcome to FDAMap Clinical. By accessing and using our website (www.fdamapclinical.com), you agree to comply with the following terms and conditions. If you do not agree with any part of these terms, please refrain from using our website.

1. About Us

FDAMap Clinical is a Contract Research Organization (CRO) providing clinical trial management, regulatory consulting, quality assurance, and compliance services to pharmaceutical, biotech, and medical device companies.

For inquiries regarding our services, please contact us at:

Call: +1 410-501-5777

Email: info@fdamapclinical.com

2. Copyright & Intellectual Property

All content on this website, including but not limited to text, graphics, images, logos, and software, is the property of FDAMap Clinical or is used with permission from third-party licensors. This content is protected by U.S. and international copyright laws.

You may not copy, reproduce, modify, distribute, or commercially exploit any material from this website without explicit written consent from FDAMap Clinical.

Any unauthorized use may result in legal action. If you wish to request permission to use any content, please contact info@fdamapclinical.com.

3. Disclaimers

A. General Disclaimer

  • The information provided on this website is for general informational purposes only. While we strive to keep our content accurate and up to date, FDAMap Clinical does not guarantee the completeness, reliability, or accuracy of any information presented.
  • By using this website, you acknowledge that:
  • The content should not be considered professional, legal, or regulatory advice.
  • FDAMap Clinical is not liable for any decisions made based on website content.
  • You assume full responsibility for any actions taken based on information from this site.

B. Third-Party Content

This website may include content, tools, or links provided by third-party organizations. FDAMap Clinical does not control or guarantee the accuracy, reliability, or suitability of third-party content. Any use of third-party materials is at your own risk.

4. External Links Policy

FDAMap Clinical may include links to external websites for informational purposes. These links do not indicate endorsement or affiliation.

  • We do not control or assume responsibility for third-party website content.
  • Linked websites may change their content, privacy policies, or terms without notice.
  • Users should review the privacy policies and terms of any external websites before engaging with them.

If you encounter issues with an external link, please contact the website owner directly.

5. Limitation of Liability

To the fullest extent permitted by law, FDAMap Clinical shall not be held liable for any direct, indirect, incidental, consequential, or punitive damages arising from:

  • The use or inability to use this website.
  • Errors, omissions, or inaccuracies in content.
  • Third-party content, services, or external links.
  • Any loss of data, business, or profits resulting from website use.

FDAMap Clinical reserves the right to modify or discontinue any part of this website at any time without prior notice.

6. Privacy Policy & Data Protection

By using this website, you agree to our Privacy Policy, which outlines how we collect, use, and protect your data. FDAMap Clinical follows industry best practices to safeguard your personal information. However, we cannot guarantee absolute security of data transmitted via the internet.

For details, please review our Privacy Policy (link to policy).

7. Changes to Terms and Conditions

FDAMap Clinical reserves the right to update or modify these Terms and Conditions at any time. Any changes will be posted on this page, and continued use of the website signifies your acceptance of these changes.

We recommend reviewing this page periodically for updates.

8. Governing Law

These Terms and Conditions shall be governed by and construed in accordance with the laws of the United States and the State of Maryland. Any disputes arising from these terms shall be resolved in the appropriate courts located in Maryland.

9. Contact Us

For any questions or concerns regarding these Terms and Conditions, please contact:

 Email: info@fdamapclinical.com

Call: +1 410-501-5777

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.