Clinical Research Services
Clinical Research Strategic and Financial Planning
Achieving a vision of growth for clinical research requires proper planning and the development of an effective strategy, applying knowledge of existing models, and benchmarking reference points. The operational realities of clinical research as well as the institution’s expertise and unique culture are also critical factors to be considered. Huron helps academic institutions realize their vision for clinical research by:
- Facilitation of Strategic Planning – Clearly articulating and vetting the future state strategic goals against available options and based on the current state environment
- Business Plan Development - Combining benchmarking data and internal expertise into a business plan with supporting financial projections.
- Implementation Planning – Formulating an actionable implementation plan which serves as a basis for monitoring progress and successes.
Some examples of our work include assisting organizations with development of financial models for clinical research, development and implementation of CROs and SMOs, facilitation of decisions related to what clinical disciplines should be studied as part of the research enterprise, and much more.
Additionally, Huron’s demonstrated expertise extends to assist our clients through the implementation process, compliance oversight and reconciliation.
Clinical Research Operations Improvement
Huron assists organizations engaged in clinical research understand their current risk, identify opportunities for improved management and implement best-practices. Huron delivers administrative reviews to focus attention on the sufficiency of policies, procedures, organizational structures, staffing, educational programming, and the technology used to facilitate key operational tasks. Managing a clinical research program is complex and commonly challenging for many of our clients. Huron will identify opportunities to enhance compliance activities, improve processes, and optimize the management of research operations throughout the continuum of activities that range from study initiation to billing and even, financial management. Huron is often requested to support implementation efforts, provide advisory services as organizations build their infrastructure, and, at times, supply Huron personnel to perform interim clinical research management services.
Responsible Conduct of Research
The attention of the public, the press, the US Congress and even government enforcement officials has focused on stories of inappropriate and even fraudulent research at healthcare institutions. In particular, conflict of interest, human research protections, and scientific misconduct are among the most recent cases. Although these stories give great attention to infrequent events, they place the public’s trust in research at risk. Organizations with a research mission, including universities, academic medical centers, hospitals, research centers, are being held accountable for ensuring the responsible conduct of research among their faculty and staff. Institutions and investigators must understand their obligations for the responsible conduct of research not only to comply with regulations, but also to maintain the public’s trust and support. Navigating the different regulations and standards that affect each area of research conduct can be challenging. Establishing operations and infrastructure that are not only compliant but also perceived as investigator- or faculty-friendly is especially challenging. The professionals at Huron offer support and services for proactive and reactive management of these issues.
Human Subjects Protections Program
Institutions involved in research with human subjects need to be in compliance with various federal regulations and ensure that the participants are suitably protected. These entities may need assistance with identifying whether they have a robust Human Research Protection Program (HRPP). Best-practice organizations demonstrate strength of their HRPP through adequate Institutional Review Boards (IRBs), credentialed and prepared IRB staff, and trained investigators and research staff. Preventive and ‘For Cause’ inspections and/or assistance with voluntary accreditation through AAHRPP can be a viable method of more readily assuring a strong and compliant HRPP. Huron provides a wide range of service including: IRB assessment, IRB interim management, assistance with all stages of AAHRPP accreditation, and much more.
Clinical Research Billing Operations & Medicare Coverage Analysis
Healthcare providers engaged in billing third party payors for routine clinical services in the context of a clinical study are responsible for ensuring that research costs are not billed to third party payors. To help enhance billing operations, Huron has assisted many academic medical centers, hospitals and health system in implementing processes for:
- Budgeting – Improved understanding of the full cost of research and increasing revenue from sponsors.
- Contracting – Decreased contracting timelines, better contractual coverage, and improved payment terms.
- Medicare (and other payer) coverage analyses – Increased use of industry best-practices for defining usual patient care from research costs in compliance with the Center’s for Medicare and Medicaid Services.
- Provider billing and coding for research services – Developing providing billing processes for identification and billing for patients on research protocols.
- Bill hold (i.e., manual bill reviews) – Designing and implementing turn-key solutions
- Third party reimbursement and overpayments – Decreasing compliance risks and ensuring proper billing.
- Billing process auditing and monitoring – Ensuring on the back-end that the processes and policies are effectively being followed.
Huron is uniquely staffed to provide the expertise and experience our clients need as they navigate technical and professional fee billing for clinical research related services. We also provide extensive training services in the areas of Medicare coverage, research billing and coding, and best practices.