Wendy Portier MSN, RN, CHRC, CHC, CPC
and
Cynthie Lawson CHRC, CPC
Research Compliance Consultants
March 24, 2025, 12:00 – 1:00 p.m. EST
Register in advance for this meeting:
https://upstate.zoom.us/meeting/register/Zbhnm6d8Q6ahni65CB9Nhg
After registering, you will receive a confirmation email containing information about joining the meeting.
Summary: Clinical research billing compliance is one of the most complex areas in healthcare compliance, requiring coordination across multiple departments, stakeholders, skill sets, processes, and regulations. The process begins with a Coverage Analysis (CA) and culminates in verifying that the claim was submitted and reimbursed by the appropriate payer.
Objectives: This session will:
Speaker Bios:
Wendy Portier has over 30 years of experience in healthcare including: Clinical Research Compliance, Clinical Research, Corporate Health Care Compliance, Managed Care, Care Management, Quality, and Critical Care Nursing. Having worked on the provider, researcher, payer and sponsor sides, Wendy has a unique perspective, extensive knowledge and real-world experience regarding clinical research compliance and operations, including: assessing sites including due diligence assessments; implementing process improvements; leading government inspections & responses; auditing and monitoring; implementing compliance programs; and improving the research billing revenue cycle – from coverage analysis, budgets, contracts, authorizations, claims review to denials & appeals management. Wendy also has a special interest in training, improving processes with best practices and assisting organizations with writing policies and procedures in a simplified manner. Wendy is currently an independent consultant in research compliance and operations. Previously, Wendy was the Medical Management Director at a health insurance cooperative start-up and served as a consultant with a major consulting firm and contract research organization. Prior to that, Wendy served as a Corporate Compliance Officer, Chief Research Compliance Officer and Clinical Research Coordinator at a major academic medical center. Wendy holds a Master of Science in Nursing in Clinical Research Management from Duke University and completed the Health Care Corporate Compliance - Post Graduate Certificate Program at George Washington University. She also holds several healthcare related certifications and has lectured locally, nationally and internationally on various topics related to clinical research operations and compliance; health care auditing; research billing; and health care compliance.
Cynthie has over 20 years of experience in financial and revenue cycle operations including clinical research billing compliance. She has a strong background and expertise encompassing study start-up to final closeout. She has extensive experience with developing and improving process flows for revenue cycle and financial systems.
Cynthie has worked in the provider and payer arena. Her experience includes: Systems build and integration, process improvements, conducting and managing internal and external monitoring and auditing, clinical trial budget forecasting and negotiations, Coverage Analysis, coding and claims processing, claim denial reviews and appeals, accounts payable and receivable, and reconciliation. Cynthie holds a Bachelor’s degree in Business Management. She is also a certified Healthcare Research Compliance Professional (CHRC) and a Certified Professional Coder (CPC).
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program will provide 1 hours of continuing education hours.
*When registering, note Certificate of Attendance Need (General or SOCRA).
April 2, 2025, 3:00 - 4:00 p.m. EST
Maneet Singh, Founder & CEO, ADI INTELLECT
Register: https://upstate.zoom.us/meeting/register/viEA11kVRUWOVr7dh-p9Eg
Data is the foundation of every drug in discovery through its success in post marketing. Most of the early stage companies start collating data points post pre-clinical, and have it in the structured form only in the clinical trial phases. This discussion will explain how data strategy acts as a foundation in the product development plan, how implementing these data strategies during discovery helps in the protocol design in the development stage. The session will also discuss some key points on writing protocol synopsis/Concept sheet.
Maneet Singh is the serial entrepreneur, Founder of ADI Intellect & QuantiNova. He has been part of regulatory Submissions of new drugs in last 2 decades. He has recently launched a Saas Based product for multicenter electronic data capturing system integrated with Statistical Analysis Application.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program will provide 1 hours of continuing education hours.
Katrina Croghan, M.S
Quality Management Coordinator, Mayo Clinic Comprehensive Cancer Center
April 14th, 2025 12:00 – 1:00 p.m. EST
Register in advance for this meeting:
https://upstate.zoom.us/meeting/register/UPCXdicaTP-TPvj2qZWoPw
After registering, you will receive a confirmation email containing information about joining the meeting.
Overview: Self-monitoring a site’s own Clinical Trials is critical, not only to address trial needs in real-time, but also to help address gaps in educational training, process improvement and more. This presentation will focus on one Comprehensive Cancer Center’s self-monitoring process utilizing 1st and 3rd participant accruals on individual trials. Ms. Croghan will walk through the reporting mechanism that communicates accrual numbers, review needs by the individual study teams and the enterprise Compliance and Quality Unit (CQU).
Objectives:
Speaker Bio:
Katrina Croghan is a Quality Management Coordinator for the Mayo Clinic Comprehensive Cancer Center (MCCCC) focusing on the enterprise Quality Management System, Which includes the establishment, maintenance, and education of al MCCCC documentation, policies, procedure and etc.
She holds a B.S. and M. S. from St Cloud State University in St. Could, Minnesota and because a Certified Clinical Research Professional (CCRP) in 2014. Katrina has been with Mayo Clinic since 2012 and started her career under the Department of Medicine- Clinical Research Office. She has been with the MCCCC since 2015 and has held Certified Clinical Research Coordinator (CRC), Lead CRC and Senior CRC within the Cancer Center prior to moving into the Quality Management Coordinator role.
Katrina is also a co-chair for the SOCRA Southeast MN Chapter as of 2022; and as accepted an Adjunct Professor position with St. Cloud State University, under the Applied Clinical Research Program. Recently in October 2023, Katrina also achieved Assistant Professor of Health Care Administration academic ranking at Mayo Clinic. She also serves on the SOCRA board of directors.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program will provide 1 hours of continuing education hours.
*When registering, note Certificate of Attendance Need (General or SOCRA).