Blog
September 6, 2023
Attain Partners Experts Discuss the Trials of Clinical Trial Tracking and Share Insights on How to Choose the Best CTMS
Clinical trials (CT) post-award management can be challenging without the support of a robust Clinical Trials Management System (CTMS). A CTMS is a specialized software application designed to streamline the management of all aspects of a clinical trial, from its inception to the final stages.
A Clinical Trials Management System serves as a centralized hub for personnel involved to update and track trial visits, milestones, invoicing, payments, and more.
The CTMS is indispensable to organizations, allowing them to maintain real-time financial records of clinical trials to invoice and receive payments in accordance with the executed agreement, consequently limiting the risk of deficits. Additionally, it aids in ensuring compliance with both internal policies and governmental regulations.
Transitioning from Manual Tracking Processes
Many organizations initially manage post-award clinical trials manually, relying on Excel templates for individual trials via a shared location. This approach can work well when dealing with a limited number of trials and well-established processes.
Key components of a successful manual CT management process include its ability to:
- Develop clear and accurate templates to encompass the specifics of each trial (e.g., patient visits, milestones, and pass-through items).
- Utilize a shared location, such as SharePoint, to allow real-time tracking and workflow to multiple parties involved in the administration and financial management of the trial (e.g., updating completed items and generating sponsor invoicing).
Upgrading to a Clinical Trials Management System
However, as an organization’s clinical trial portfolio grows, manual processes become unsustainable. At this stage, investing in a CTMS becomes a strategic move to ensure accurate patient activity tracking, billing, and collections.
An effective CTMS should have the flexibility to accommodate a wide range of study types, from traditional clinical trials to summary accrual and registry clinical trials. It should also be adaptable for one-off trials that may require milestone-based invoicing, among other features.
Other crucial factors to consider include the system’s ability to:
- Allow multiple departments access to update relative data (e.g., clinical research coordinators, clinical finance team, and central finance office for receivable tracking and collection).
- Support multiple budget amendments to accommodate changes in study parameters.
- Incorporate visit fee changes, additional visits, or reductions in visit types.
- Seamless integration with existing systems (e.g., invoicing/financial systems and patient visit systems that designate clinical trial visits).
Ideally, a CTMS will create the invoice and wait for a post-award manager to submit it, and the invoice will be automatically emailed to the sponsor via the CTMS. The system will also send follow-up emails to sponsors for outstanding invoice payments based on the payment terms. At the very least, the CTMS should email the finance team that the Clinical Research Coordinators add patient visits, pass-through items, or milestone items for invoicing.
Enhancing CTMS Reporting Functionality
In terms of reporting capabilities, an ideal CTMS should offer:
- Accurate reporting of patient visits and milestones completed with payments received and outstanding invoices
- A report of all studies currently requiring invoicing; the system might even ping the financial contact to submit invoicing or follow up on outstanding invoice payments monthly
Clinical trials post-award management may seem daunting at first because it requires input from various departments within an organization. This offers great opportunities to build valuable relationships between study teams and central offices.
Attain Partners – Clinical Trial Management Expertise
Attain Partners has a team of experts in clinical trial management, each with extensive experience in various types of CTMS applications. Our experts can assist your organization in streamlining its clinical trials portfolio and guide you in selecting the most suitable CTMS to meet your organization’s specific needs. Our consultants excel in system integration and personnel training for a seamless transition to a CTMS solution. Contact us today to learn more.
About the Author
Kedeisha S. Carty is a Senior Associate at Attain Partners with over 15 years of experience in Higher Education focusing on research management. She has extensive experience in clinical trials management, pre- and post-award management, and managing post-award grant research. Kedeisha holds an MBA in Business Administration.
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