Debbie McAllister Consulting - Health Care Regulatory Compliance

Our Services

Clinical Trials Compliance Strategic and Operational Consulting Clinical Trials Revenue Cycle Centralized Clinical Trials Offices and Research Institutes Interim Management / Outsourcing Specialized Research Compliance Training Corporate Compliance Compliance Effectiveness Reviews Litigation Support Regulatory Due Diligence

Centralized Clinical Trials Offices and Research Institutes

"The most successful businessman is the man who holds onto the old just as long as it is good, and grabs the new just as soon as it is better."
- Robert P. Vanderpoel

Funding from the National Institutes of Health (NIH) is at its lowest levels in ten years while annual applications are at the highest. Only 1 in 10 approved applications are funded. Even established researchers are facing uncertainty about their longevity as active scientists.

On the other hand, R&D spending by U.S. pharmaceutical companies reached record highs during the same period, but higher education institutions and academic medical centers continue to lose market share. Why?

One of the biggest culprits is decentralization. In a decentralized environment organizational growth is based on productivity levels of individuals while the degree of compliance with applicable laws is inversely proportional to the number of researchers employed. From a researcher's perspective, there is an overall lack of administrative support at both pre- and post award levels, navigating institutional processes and procedures is typically an exercise in frustration, and the required paperwork is viewed as overly burdensome and frankly, not worth the effort. Pharmaceutical companies also cite costly and time-consuming processes associated with decentralized institutions as one of their biggest sources of frustration.

Centralization not only offers investigators, their staff, and hospital personnel a single, ascertainable resource to obtain necessary guidance and administrative services, but by ensuring consistency in budget preparation and negotiations with commercial sponsors, provides the institution with a number of competitive advantages as well. McAllister Consulting is one of few firms experienced in developing centralized clinical trials offices or research institutes.

Case Studies

McAllister Consulting has years of healthcare knowledge and experience. They understand the issues and diverse audiences involved in conducting clinical research and offer clear, practical advice on how to craft an effective compliance program and structure a centralized office to proactively manage clinical research throughout a 31-hospital health system. As an authoritative third-party, their findings from a comprehensive assessment of all of our practices were well received by members of the Research Institute and IRB. McAllister not only helped us create and implement a research compliance program, but enhanced our overall regulatory knowledge through her service as the interim Research Compliance Officer.

Sheri Sanders, former Director - Banner Health Research Institute