Scientific / Clinical Services

All of Opus Three’s activities are based on a solid understanding of the science that drives an assignment. However, we don’t believe that understanding alone is sufficient – we want to be able to help our clients innovate and grow, find new ways to solve a problem. We can help you identify the right technologies and platforms, find novel or alternative ways to generate critical data, or design research studies, all with an eye on regulatory context and market access to ensure a focused product development.
Clinical R&D can be challenging in particular when a variety of different interests need to be addressed. For example, what is the best way to generate data for regulatory clearance of a new diagnostic while also creating health economic information necessary for coverage and reimbursement? Our team has experience designing randomized controlled trials, quasi-experimental trials, observational studies and other real-world, outcomes-oriented strategies to make sure you generate the evidence supporting your product in the most efficient manner.

Representative Services

  • Biomarker identification, characterization and qualification
  • Responder- and non-responder identification

Typical Challenges we Encounter in Scientific/Clinical Services

  • What are the challenges aligning the development of a diagnostic with the much longer, more complex development of a new drug therapy?
  • I’m starting a new business. How can I align my product development milestones with my business strategy?
  • Do I need to submit my product to the FDA for review or should I use an alternative (e.g. a laboratory-developed test, LDT) approach? What are the pros and cons of each approach?
  • How does the laboratory/diagnostic market evolve for my product? Should I invest in this market?
  • Biomarker identification, characterization and qualification
  • Responder- and non-responder identification
  • 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?
  • 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

Examples of Completed Assignments

  • Laboratory strategy, including LDT, CLIA versus 510(k), PMA kit development
  • Development of online education (multi-module course) for personalized health care
  • Advisory committee and expert testimony at senior management and strategy retreats
  • Lectures and courses/workshops at national and international conferences and workshops
  • 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)

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