i3 Consult to Apply its CTR Reporting for Observational Studies in Pre-Approval and Post Marketing



Since the passing of the 21st Century Cures Act, observational studies have been a growing ally to traditional clinical research in the biopharmaceutical and medical device approval process, culminating in many companies to take the initiative to use real-world evidence. However many companies experience formidable “stop gaps” in amassing sufficient real world evidence.

As i3 Consult continues to offer its weekly clinical trial reports (CTR) at www.i3consult.com/i3-clinical-trials-report/ on new drug therapies currently in clinical trials worldwide, we are seeking to use our CTR database as real world evidence in helping our clients to address the following critical success issues:
  • Is the research sufficiently patient-focused?
  • Have sufficient observational studies been used in the pre approval and post market stages?
  • Are there further opportunities for observational study data to save you time and money in your current clinical trial investigation?
  • How observational studies can make a viable alternative to clinical trials or bridging studies
  • To identify stakeholders and determine what kind of observational research data is needed
Who will benefit from our CTR referral services:

1. Clinical project specialists
2. Clinical research associates
3. Compliance officers
4. Consultants/service providers
5. Data management and statistics personnel
6. Executive management
7. General/corporate counsel
8. Investigators
9. Managers
10. Manufacturing directors and supervisors
11. R&D staff
12. Regulatory/legislative affairs professionals
13. Risk management specialists
14. Strategic planning and business development staff
15. Study monitors
16. Study research coordinators
17. Study sponsors

Best regards,
Dr. Wallace Macindoe,
CEO & Founder of i3 Consult.
i3 Consult- Integrated Intelligence for Healthcare Industries.


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