Speakers

Amanda Miller

Amanda is the Training Program Manager for PFS Clinical.  She has detailed clinical research experience providing expertise in administrative roles such as budget development/negotiation, coverage analysis development, and coverage analysis quality assurance.  Her work with a large array of research sites, from large academic medical centers, dedicated research facilities, major medical centers, and community hospitals, provides Amanda with a well-rounded perspective of clinical research and a comprehensive understanding of the administrative needs of clinical research sites.

Representative Examples of Amanda's Project Experience:

  • Generating best practices and performing quality assurance on coverage analyses for research institutions across the Midwest, California, and Texas.

  • Developing and negotiating budgets on behalf of research sites, focused on an academic medical centers, to ensure the most financially advantageous budget for the sites.

  • Providing a primary point of contact and account management for numerous research institutions to ensure short turnaround times and quality deliverables are met for each clinical trial.

  • Assisting institutions with the development and implementation of institutional policies related to coverage analysis and budgeting.

Education:

  • Bachelor of Science, Biology, Saint Mary’s College

  • Master of Science, Entrepreneurship/Science & Engineering, University of Notre Dame


Jody Ingebritsen-Howe

Jody Ingebritsen-Howe is a Manager of Contracts and Compliance at PFS Clinical. Jody has extensive experience in the legal and healthcare industries, including over 5 years’ experience with legal analysis in her past experience with litigation investigations, including contracts and medical documents. She has collaborated with an extensive variety of research sites, including large academic medical centers, major medical centers, dedicated research facilities and community hospitals, providing Jody with a well-rounded perspective of the contracting needs of each type of research site.

Representative Examples Of Jody's Project Experience:

  • Conducting contract analysis on complex agreements related to clinical trials and company policies

  • Analyzing and expediting resolution of legal issues in clinical trial contracting process

  • Negotiating with clinical research organizations and study sponsors to establish mutually-agreeable contract terms

  • Developing compliance procedures and protocols

Education:

  • Bachelor of Science, Legal Studies, University of Wisconsin-Madison


Bailey Lyons

Bailey is a Senior Clinical Research Contracts & Compliance Analyst for PFS Clinical. Bailey has over 5 years of increasingly complex experience and training in the legal industry, including experience with clinical trial contracts and negotiations, development of training materials and programs, and research, interpretation and compliance with applicable laws and regulations. Bailey has provided support and collaboration to a variety of research sites through her work with PFS clinical.

Representative Examples of Bailey’s Project Experience:

  • Conducting analysis and negotiation of clinical trial contracts for research sites in alignment with clinical research standards and internal client policies and procedures

  • Researching and interpreting applicable laws to ensure compliance and expedite resolution of legal issues with clinical trial sponsors

  • Providing support and assistance in developing compliance policies and procedures

Education:

  • Bachelor of Arts - University of Wisconsin-Madison

  • Post-Baccalaureate Paralegal Diploma, Madison College


Emma Neale

Emma Neale is a Senior Clinical Research Analyst at PFS Clinical. There she oversees the start-up process of clinical trials from coverage analysis to budget development to CTMS implementation for large hospital research systems. In her current role she manages the use of CTMS to enhance study budget negotiations and clinical scheduling. What she enjoys most about clinical research administration is the problem-solving aspect of clinical operations and providing support to allow study teams to improve patient care.

Representative Examples Of Emma's Project Experience:

  • Developing the coverage analysis for research institutions participating in clinical trials to ensure billing compliance and the optimization of study funds.

  • Analyzing and negotiating budgets for large network clinics and hospitals participating in industry clinical trials across the country.

  • Providing internal budget development expertise for IIT studies to maximize research awards.

  • Establishing CTMS strategy for the successful execution of a research study and its budget.

Education:

  • Bachelor of Science, Genetics, University of Wisconsin – Madison

  • Certificate in Business Management for Agricultural and Life Sciences, University of Wisconsin – Madison