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 bio-pharmaceutical 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:
- Clinical project specialists.
- Clinical research associates.
- Compliance officers.
- Consultants/service providers.
- Data management and statistics personnel.
- Executive management.
- General/corporate counsel.
- Manufacturing directors and supervisors.
- R&D staff.
- Regulatory/legislative affairs professionals.
- Risk management specialists.
- Strategic planning and business development staff.
- Study monitors.
- Study research coordinators.
- Study sponsors.
Dr. Wallace Macindoe,
CEO & Founder of i3 Consult.
i3 Consult- Integrated Intelligence for Healthcare Industries.