- Design and planning for clinical trials, including alignment with diagnostic partner
- Creation of trial protocols, IRB submissions, patient-facing documents, including surveys, patient-reported outcomes forms, and other clinical documents
- Trial site identification, setup and management, patient identification and recruitment strategies
- Clinical reports and regulatory documentation
- How should phase 1 and 2 studies be conducted to satisfy regulatory expectations and enable the stratification of the patient population using genetic biomarkers? How does it impact reimbursement?
- How do I design my clinical trial if I want to incorporate a biomarker?
- Do I need to prospectively select patients based on biomarker data or can I evaluate this information retrospectively?
- Alignment strategy, trial design drug-test co-development effort in inflammatory-bowel syndrome
- Phase 2 and phase 3 clinical trial design for oncologic drug development effort
- Development of company-wide strategy to incorporate DNA collection in all clinical trials (pharma client)
“Opus Three assisted our company over a period of 4 years in determining path to market, product priorities, and regulatory strategy. Their extensive and up-to-date knowledge of the global regulatory environment and the clinical evidentiary demands was excellent, and enabled the company to successfully navigate the changing healthcare landscape as a young technology-based company.”
“Opus Three provided sure-footed guidance for a plan to obtain FDA approval for a new infectious disease diagnostic, and the clinical studies required to compile the necessary data.”
“Dr. Frueh has provided our company with extremely useful guidance in exploring the commercialization of a Genetic Test for Depression. His pragmatic detailed strategic advice has been coupled with magnanimous personal network connections, at the highest levels of this sector.”