Debbie McAllister Consulting - Health Care Regulatory Compliance

Our Services

Clinical Trials Compliance Strategic and Operational Consulting Specialized Research Compliance Training Corporate Compliance Compliance Effectiveness Reviews Litigation Support Regulatory Due Diligence

Corporate Compliance

“Don't think you're on the right road just because it's a well-beaten path.”
- Unknown

At McAllister Consulting, we have the knowledge and experience to address your unique regulatory concerns. With our years of industry experience and “lessons learned” approach, we are able to bring valuable insight and knowledge to the decision-making process, enabling our clients to address key regulatory questions, such as “What is the risk of not doing something and what are the possible repercussions?”

We perform a variety of corporate compliance services to ensure aspects of your compliance program reflect best practices in the industry, but we don't offer “canned” solutions for individual compliance needs. We also work closely with our clients to develop project scopes and audit / review plans to meet individual budgetary constraints.

Some examples are some of the general corporate compliance services we offer:

Comprehensive and focused risk assessments
Development of corrective action plans for identified risk areas
Drafting policies and standard operating procedures
Design of ongoing auditing and monitoring programs

Our clients represent a broad array of organizations along the entire health care continuum, from universities and their affiliated academic medical centers to stand-alone specialty facilities and large physician practice groups, as well as medical suppliers and sponsors of clinical trials. Our services have ranged from conducting comprehensive organization-wide assessment to conducting focused assessments on a single issue.

Case Studies

Children's Hospital and Health System utilized McAllister Consulting to conduct a risk assessment and provide clinical research education to staff. The resulting knowledge transfer met and in some cases exceeded our expectations. I found their depth of knowledge and “hands-on” experience with regard to clinical research overall excellent, but in particular, the application of their knowledge and experience to the unique issues associated with pediatric research was outstanding.

Tom Twinem, Director, Corporate Compliance – Children's Hospital and Health System