This blog post is part of an ongoing series on the RxRM initiative at PowerObjects—configuring Microsoft Dynamics CRM to address the highly specialized needs of healthcare organizations. This post features guest blogger Timothy Pratt, Ph.D., Solution Design Consultant for the Health and Life Sciences at PowerObjects.
So, why do hospitals and clinics need CRM in clinical research?
Well, to be honest, they don’t. Need CRM that is. Dynamics CRM has often been touted as an “XRM”—a system that can manage relationships for just about any purpose—but clinical research is more than relationships alone. After all, what characterizes clinical research at its most fundamental level? FDA or regulatory compliance? Informed Consents? IRB or EC review? Protocols? Case Report Forms (CRF’s)? EDC? HIPAA? Sponsors? CRO’s? All of these of course form part of nearly all clinical trials – but there’s a common element, fundamental and critical to quality outcomes: Process. The very essence of scientific inquiry is process. By process variables are controlled and quality data acquisition is assured.
The emphasis on process is such that Dynamics CRM or XRM alone can’t meet the needs unless solutions are developed on the platform by experts. What is needed is RxRM, that is, Dynamics CRM specifically designed to take into account the problems encountered in conducting clinical research at the institutional level. The specific RxRM module we need is the clinical trial management system (CTMS).
The problem facing many hospitals and clinics is that the very significant number of process steps need to occur, often at tightly defined time-points and usually over time frames that can span years from first IRB/EC submission to last-patient-out. When considering that the Research Coordinator must manage investigator, physician, and patient (subject) activities, and the requirements of every clinical trial varies from others, it’s hardly surprising that process missteps often occur.
If the goal of any clinical research is good quality data, and the means by which that is achieved is process, then it follows that compliance is the mechanism by which desired results are obtained. An RxRM CTMS should be designed to foster and promote compliance – not as an overlay of additional work, but as a supporting tool that actually adds value by reducing errors, reducing the burden of work for all trial participants, providing visibility into overall activity, monies owed, projected income and work burden and more. Through judicious use of configurable processes, RxRM CTMS will ideally keep clinical activities on-track whilst still allowing for the flexibility that anything involving patients and physicians requires.
What should a clinical trial management system (CTMS) do?
- Handle documents
- IRB and EC submissions, e.g., Protocol, Consents, CRF’s, patient brochures etc.
- Personnel files, e.g., medical licenses, CV’s, financial disclosures, FDA 1572 forms etc.
- Contracts and Clinical Trial Agreements
- Facilitate required activities/data collection
- Visit scheduling within specific protocol-required windows
- Automatically associate protocol-required activities and tasks with the appropriate visit
- Allow for resource allocation and planning with forward looking view of upcoming scheduled work by user-definable time-frame, e.g., next week, next 14 days etc.
- Produce financial reports
- Invoices to trial Sponsors for work performed
- Reconciliation of funds received against activities completed
- Projections of future cash-flow based on automated visit windows/scheduling
Happily the Microsoft Dynamics CRM platform can readily facilitate all of the above key activities, enhanced by its interoperability with other Microsoft products such as:
- Document libraries, archiving
- SQL Server
- Role based security
- Field level security
- Point & click reports and analytics
- MS Office
- Outlook schedule synchronization
- Mail-merge for Word documents
- Email tracking
- .NET framework underpinnings
- Easy extensibility for IT professionals
Of course the Dynamics platform itself gives us necessary compliance-enhancing aging and escalation of tasks and activities and core CRM functions can be used with little additional configuration to schedule and track communications to patients and sponsors (or a CRO) alike. The alternative, all too common, is a collection of post-it notes, excel spreadsheets, inconsistently stored files with all the non-compliance and missed opportunities that situation brings with it.
A very simple sample workflow or use case within RxRM CTMS can be sketched out as follows:
In the above scenario, submissions, fees, documents and visits are all tracked and the user alerted to upcoming required tasks and critical dates. From the very simple task of ensuring only the approved informed consent is used through to automatic generation of invoices for work performed decreases burden of work and increases compliance, all while ensuring the institution receives the reimbursement and fees they’re entitled to. Automatically.
Learn more about the RxRM Clinical Trial Management System developed by PowerObjects.
About Our Guest Blogger
For the past 25 years, Dr. Timothy Pratt has worked around the globe both as a clinician and technology solutions designer/advocate in the life sciences and healthcare industries enhancing patient care, profitability and productivity in areas including clinical trial operations, practice/market development, sales and systems integration. Leveraging post-graduate qualifications in cardiology, cardiac electrophysiology, critical care, psychiatry and business, Dr. Pratt has assisted organizations from small start-ups and clinics to Fortune 500 enterprises source and adopt technology solutions that dramatically improve outcomes for patients, practices, life science companies and hospital systems. A firm believer in automating processes to reduce costs and provide visibility into critical data, Pratt is known for his work as a long-time member of the Applied Clinical Trials Journal editorial advisory board and many publications and lectures regarding information technology use in the healthcare and life sciences space.
At PowerObjects, Dr. Pratt’s role is to collaborate with healthcare organizations to drive the design and delivery of technology solutions that run the gamut from referral management, community outreach campaigns, clinical trial operations systems, chronic disease management, grant management, safety surveillance/monitoring and health maintenance/prevention programs.