Unlocking the Full Value of Your Clinical Trials Management System (CTMS) Investment

Transcription

1 Unlocking the Full Value of Your Clinical Trials Management System (CTMS) Investment May 28, 2014 YOUR MISSION OUR SOLUTIONS Huron Consulting Group Inc. All Rights Reserved. Huron is a management consulting firm and not a CPA firm, and does not provide attest services, audits, or other engagements in accordance with the AICPA's Statements on Auditing Standards. Huron is not a law firm; it does not offer, and is not authorized to provide, legal advice or counseling in any jurisdiction.

2 About the Speakers Dan Lodes, Director Dan has over twenty years of experience implementing packaged software applications in healthcare, NCI designated cancer centers, consortiums and academic medical center environments. His experience includes project management on a broad range of projects including clinical trial management systems, EMR, and other research administrative applications. Erin Pennington, Manager Erin brings more than 14 years of experience as a Clinical research professional with experience managing large scale clinical trials offices both in a NCI designated Cancer Centers and across an Academic Medical Center. Her expertise includes Research Billing Compliance, Clinical Trial Management System Implementations, Research Infrastructure Development, Oncology Phase I-III trials, Human Subjects Protections, and ICH-GCP s.

3 Session Agenda Review reasons for underutilization of Clinical Trial Management Systems (CTMS) Identify opportunities for optimization Discuss optimization strategies Closing remarks Questions

4 Polling Question Is your institution using its CTMS to the fullest potential? Currently not using a CTMS I'm not sure No - not fully utlized Good, but room for improvement Total % Yes - We do a great job! 0% 5% 10% 15% 20% 25% 30% 35% 40%

5 Polling Question What is your role with respect to your institution's CTMS? My institution does not have a CTMS I have no interaction with CTMS System administrator Indirect end user Total % Direct end user 0% 5% 10% 15% 20% 25% 30%

6 Common Reasons for Under-Utilizing a CTMS

7 High Level CTMS Data and Workflow Research Administration Protocols Study-Level Administration Schedule of Events Participant-Level Administration Participants Budget and Contracting Regulatory Data Capture Visit Tracking Sponsor Invoicing Data Management

8 Outcomes of a Fully Optimized CTMS Funding / Federal Agencies NCATS / NCI push for metrics, standards and greater efficiency Mandates from federal agencies (e.g., ClinicalTrials.gov requirements) Compliance Address potential regulatory and billing compliance issues Create and enforce oversight Improved Operations Standardize processes and build a metrics driven environment Simplify clinical research technology environment Support Research Community Assist investigators in driving and managing research Increase transparency to support study staff and clinical research leadership

9 Under-Utilization PLANNED Many institutions start with a smaller scope for their CTMS: Limited scope based on prioritized functional requirements A drop dead date for a specific organizational need or set of functional needs Implementation based on available budget / resources

10 Under-Utilization UNPLANNED Other times unexpected events occur that impede the use of the system: Vision of the project and benefits of the system were not clearly communicated Limited acceptance of the system and a lack of leadership support

11 Under-Utilization UNPLANNED Processes and staff are not aligned to work in concert with, and leverage the new technology Degree of difficulty, competing priorities and resources required not properly assessed and managed

12 Why is Under Utilization a Problem? Low Return on Investment Frustration among the research community Low acceptance of the system Process inefficiencies Inconsistent data and minimal data integrity Compliance risks Unreliable metrics and unusable reports Less efficient research

13 Opportunities for Optimizing a CTMS

14 Operational Optimization All institutionally-relevant features of the system are implemented System is used by all members of the research community Data is current, accurate and reliable Lesser Utilization Optional, department managed CTMS use Basic system mandates and standardized system policies and procedures System QC / QA policies and procedures defined and enforced Shadow systems and manual processes fully replaced by CTMS System implemented and used consistently across entire enterprise All major reporting driven by CTMS Greater Utilization Integrated with other enterprise systems Expectations clearly defined and enforced by leadership System is the single source of truth and integrated with other systems

15 ADVANCED INTERMEDIATE BASIC Functional Optimization Protocol Management Participant Management Study Financial Management Trial Registry Key Reporting Fields Participant Registry Enrollment Monitoring Basic Budgeting Medicare Coverage Determination Trial Life Cycle Mgmt Regulatory Approvals Turn-Around Reporting Participant Visit Tracking Adverse Event Tracking Eligibility Verification Sponsor Invoicing Study Payment Tracking Manual Research Claim Review Process Electronic Study Files Electronic Data Capture Advanced Protocol Metrics Participant Procedure Tracking Specimen Tracking EMR Integration Financial System Integration Line item Receivables Reconciliation

16 Institutional Optimization If initial implementation scope was limited to a specific department(s), is expanding user base a viable option? Is initial targeted user group fully implemented? If live at cancer center, can school of medicine benefit from CTMS? If live across enterprise, is system mandated for all schools and departments? Does your software license agreement allow for it? Enterprise-wide implementations of systems initially purchased by cancer centers are becoming more common

17 Technical Optimization and Integration Ad-Hoc Query Tools Access Control, Single Sign On Research Systems Clinical Systems Grants IRB CTMS EMR Data Warehouse Financial Systems Provider Billing

18 Workflow and Workforce Optimization Operational processes can sometimes be the cause of underutilization of a CTMS Are your workflows allowing you to take advantage of all the benefits your CTMS offers? Operational responsibilities match system responsibilities Reduce / eliminate handoffs where possible Keep system responsibilities closest to the people who own operational processes

19 Strategies for Optimizing Your CTMS

20 Optimizing Your CTMS Overview Given these implications, institutions should consider these steps to optimize CTMS use: Manage optimization like a project (Re)Assess system capability and your institution s needs Review processes and roles 4 Review training

21 Optimizing your CTMS 1 Manage Optimization as a Project Identify and prioritize optimization projects Low hanging fruit Timeline / deadline requirements Greatest benefit for end users Compliance concerns Study-related costs being overlooked Clearly define project plan(s) and approach Define scope and goals Determine roles and responsibilities Closely manage status, issues & timeline Measure progress and successes Secure support and funding Define your business case Gain leadership support Convene a steering committee as needed Secure appropriate funding and resources Communicate Share project scope and goals with all who are impacted by project(s) Update stakeholders regularly Define feedback mechanisms Prepare to adapt based on feedback

22 Optimizing your CTMS 2 (Re)Assess System Functionality and Your Needs

23 Optimizing your CTMS 3 Review Processes Align processes to the new functionality Did you reassess workflows and processes during the implementation? Previous workflows, roles and responsibilities may no longer meet the needs of the institution Use CTMS as an opportunity to streamline processes, reduce duplicate effort and increase efficiency Define workflows that take advantage of the functionality offered by the CTMS

24 Optimizing your CTMS 4 Evaluate Training How effective has your training been? Are you meeting the needs of your end users? Do you solicit / measure feedback on the effectiveness of your training? Do your materials and methods address the unique needs of different departments/work groups? Should alternate training delivery methods be explored? What training content updates are required? If there will be changes to functionality, processes, or roles update training materials accordingly

25 Final Thoughts You aren t alone the need for optimization is common Chart your new path and put a plan in place to move forward! Wash, rinse, repeat A continually changing regulatory landscape, financial pressures, software enhancements, etc. are all drivers for a process of continued assessment and optimization.

26 Questions?

27 Contact Information QUESTIONS? Dan Lodes Phone: Erin Pennington Phone: Michelle Faurot Phone:

28 Clients include: More than 95 of the top 100 research universities Nine of the top ten largest healthcare systems - ranked by Modern Healthcare Eight of the top ten largest Children s hospitals Many of the premier academic medical centers Huron Consulting Group Inc. All Rights Reserved. Huron is a management consulting firm and not a CPA firm, and does not provide attest services, audits, or other engagements in accordance with the AICPA's Statements on Auditing Standards. Huron is not a law firm; it does not offer, and is not authorized to provide, legal advice or counseling in any jurisdiction.