Clinical Services

Clinical Services

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

  • 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

Typical Challenges we Encounter in Clinical Services

  • 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?

Examples of Completed Assignments

  • 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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