Litigation Support

"The United States is a nation of laws: badly written and randomly enforced."
- Francis Vincent "Frank" Zappa, Jr.

Ideally, effective compliance programs will prevent wrongdoing, or at least detect it in the early stages. However, despite best efforts, inappropriate activity can and does occur. McAllister Consulting is experienced in conducting internal investigations in order to facilitate voluntary disclosures of inappropriate activity or respond to government subpoenas. After completing an investigation, we further assist clients in taking the necessary steps to correct the problem and prevent possible recurrence of the inappropriate behavior.

In the clinical research arena, we've drafted responses and corrective action plans to help clients meet the requirements of FDA Warning Letters, Determination Letters issued by the Office of Human Research Protection (OHRP) or similar actions by other government agencies, such as the National Institutes of Health. We have also been called upon to serve as the Independent Review Organization (IRO) under Corporate Integrity Agreements (CIAs) involving billing for investigational services.

Case Studies

Contact us today to learn more about our services. We'll let you know upfront if we can help.