When selecting a technology platform for management of clinical trials, study sponsors face more than a few potentially costly decisions & tradeoffs. The first challenge in selecting a technology (or technologies) is understanding one’s options – the wide scope of operations supported by various vendor systems can make comparing two systems difficult.Among the most common platforms used by Sponsors to manage studies, study information, and study documents are:
- Clinical Trial Management Systems (CTMS) – an application that is primarily used to manage the data & documents about a clinical trial (in contrast to an EDC system which manages the actual clinical trial data)
- Microsoft Sharepoint – a highly configurable and customizable tool that includes deep document management functionality and has the familiar look and feel of Windows File Explorer
- Microsoft Office (Excel, Word, Access) – The old standbys, extremely flexible and common office productivity applications that can be used by teams to track and manage information about clinical trials
- Electronic Data Capture (EDC) systems – an application that is primarily used by Site users to enter clinical trial data and respond to data queries which arise throughout the study
CTMS applications, while designed specifically for the purpose of managing clinical trials, have commonly required a long and expensive installation and configuration process. The availability of CTMS Software-as-a-Service has helped ease this to some extent, but what often remains as the next major hurdle is achieving the benefits. CTMS business cases are often built on the premise of providing a ‘single source of the truth’ but in practice this can be difficult as users feel intimidated by the complexity of CTMS or important data entry permissions are tightly restricted in attempts to manage data quality.
The Microsoft Sharepoint platform is very popular across multiple industries and enterprises and the basic technology setup costs are typically low unless you choose to do extensive customization (and it is more or less fully customizable and interoperable with Excel and Access). Its document repository capabilities can be put to work right away, and its “shared lists” features can be used to move spreadsheets online, but it still can be a less-than-optimal experience for end users – at a recent conference, a speaker described Sharepoint as “the graveyard for documents.”
Some sponsors elect to utilize more manual methods to track and manage their studies – the common tools used in these cases are MS Excel, MS Access, MS Word, and email. While Excel retains its hold as the tool users are most comfortable with, keeping track of various document versions, being confident that you have the latest information about a study, and demonstrating 21 CFR Part 11 compliance are very difficult obstacles to success in this type of model.
EDC applications continue to evolve from their core function as a data entry point for clinical trial subject data; software vendors are adding traditional study management features to make their product even more compelling. As a study management tool EDC can only provide a limited set of operational metrics and document management capabilities. Additionally, the focus of these systems on single study “databases” limits their capabilities to report consistently across more than one study. Of all the options discussed here, EDC systems are the most likely to require a long and costly implementation/installation process.
In Clinical Trial Management Technology, Can One Size Fit All?
It would be ideal for a sponsor to find a single platform that best fit their needs – but in reality sponsors may leverage more than one of the platforms mentioned above. Beyond a single tool for managing studies, sponsors also need to support the remaining facets of clinical development operations such as clinical program planning, study/protocol design, investigator recruitment, analysis & reporting, contracting & finance, etc. To do this most effectively, each of these systems must be able to efficiently exchange data and information – a challenge that is beginning to be addressed through data interchange standards for the pharmaceutical industry.
Progress has been ongoing – groups such as CDISC and BRIDG have defined some widely accepted clinical data standards but standards for clinical trial management domains remain low on the priority list, which makes clinical trial management data integration efforts less reusable than their standards-driven cousins. Given the central role that clinical trial management systems play in a sponsor’s clinical development technology ecosystem, development of CTM data standards will be a critical success factor in the ability of sponsors to acheive the benefits expected from clinical trial management technology platforms.
Closing Thoughts
The era of CTMS as “the” central location for data entry seems to be on the decline – user frustration with existing options has driven other clinical development system platforms to add features and functionality that traditionally have been in the domain of CTMS. Although most of today’s CTMS applications were created with a wide functional scope, they still have critical gaps to be addressed in interoperability, data analysis/decision-making capabilities, and ease of use. It seems likely that in five years, user expectations of CTMS will have shifted from data entry to workflow reporting & analysis, with the CTMS expected to seamlessly consume data from various tools and systems used across the clinical trial lifecycle.
The fragmentation of the clinical development systems landscape is even more dramatic when one considers the increasing number of externally-hosted SaaS applications. Although there was some initial hesitancy on the part of sponsors to allow precious clinical trial data to be held “offsite,” the compelling cost and resource benefits of SaaS have helped to overcome this hesitancy and drive adoption. SaaS applications still require planning and effort in order to be smoothly incorporated into a sponsor’s clinical system portfolio, and sponsors with the ability to do so at speed will retain the flexibility necessary to exploit the forthcoming opportunities and changes in clinical development technology.
If you liked this article and are interested in learning more about how we are making clinical trials simpler, send us an email to ttullis@gobalto.com
About the Author
Todd Tullis is a Director of Product Management at goBalto. He has twelve years experience helping pharma, biotech, device, contract research, and AMC organizations identify, select, and implement CTMS and EDC technology products.
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No mention of eTMFs? Sharepoint is just one example of a document management tool. The most exciting innovation recently is the development of clinical trial specific document management systems, known colloquially as electronic trial master file (eTMFs). When incorporating the DIA TMF Reference Model an eTMF can significantly improve compliance, process efficiency and collaboration.
@ Rammell Consulting: Agreed that eTMFs are a good solution for clinical trial document management and can have significant benefits. Have you worked with eTMFs that have breadth of functionality to support other facets of trial management such as tracking site selection, investigator payments, and trial milestone planning/tracking? My perception of the eTMF products on the market is that while they can easily meet document management needs, functional gaps remain relative to traditional clinical trial management solutions.
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