Clinical Research and Compliance

Healthcare & Life Sciences

August 25, 2014

Advancements in clinical research in the United States and abroad have significantly changed the way that health care services are delivered. It is possible that in the next 20-30 years, many of the diseases that we face today will be eradicated as a result of the efforts of scientists and research institutions such as academic medical centers.

As these advancements proliferate, however, federal dollars for discoveries in science and medicine are dwindling and the federal government’s enforcement agenda has grown dramatically. Some of the areas in which the government has been most active include: research billing, conflicts of interest, research misconduct, federal grants compliance, effort reporting, and compliance with human research protections regulations. FTI Consulting’s Clinical Research and Compliance Practice -- which includes some of the nation’s foremost authorities on research compliance and human research protections -- is well positioned to assist research organizations in navigating and/or avoiding issues with research, enforcement and regulatory agencies.

How We Do It?

Research Billing

  • Medicare Coverage Analyses (Training and MCA Prep)
  • Release of Bill Holds (in concert with Rev Cycle Team)
  • Research Billing Assessments and Performance Improvement
  • Policy and Procedure Development and Training

Human Subject Protections

  • Establishment of Human Research Protection Programs
  • AAHRPP Accreditation Preparation
  • Best Practices Assessments of HRPPs and IRBs
  • Interim IRB management and staffing, (IRB Chair, IRB staff)
  • Policy and Procedure Development and Training
  • Management of Tissue Repositories
  • HIPAA/HITECH Act Research Compliance

More Info

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