There has been quite a lot of discussion within the clinical trial management industry regarding new improved CTMS and study setup products. These new CTMS solutions all seem to focus on updating the traditional model with a slick, user-friendly interface as well as overall improved functionality (which is great). However, in my experience, truly elegant CTMS product design taps directly into peoples’ existing framework and understanding, reducing the learning curve to a flat line. Countless cumulative person-years have been spent creating documents, performing calculations and managing calendars using the Microsoft Office products. The old paradigm of monolithic CTMS is dead; but if all that replaces it are slicker clinical trial management systems, then aren’t we still missing the point? CTMS provides the controls needed for a regulated environment and this data should then be surfaced into the software framework that people already understand…that’s elegant CTMS product design.
The Business Value of Synchronizing CTMS Data with Microsoft Office
I agree with the experts that say there will always be a need for a CTMS that is dedicated to managing the end-to-end process in a compliant manner. And certainly there will always be a requirement for core clinical operations folks and other trial stakeholders to access this CTMS environment directly. But when talking about the business value of synchronizing CTMS data with Microsoft Office, it is important to also think about the additional people that only need review and approval access to this information. For example, some executives may simply require an overall study health scorecard with a drill-down capability. Or all the site monitors, other CRAs, medical monitors and even investigators as well as site coordinators; anyone that needs access to the valuable CTMS data to make informed decisions and perform their study roles effectively. Very few of these auxiliary users want to be trained on the CTMS itself or be required to log into that environment, especially if they’re working across multiple studies for different sponsors (e.g. CROs and site networks); each potentially using a unique CTMS solution (vendor’s product, home-grown, spreadsheets cobbled together, etc.).
I’ve been involved with projects that took advantage of reusable web services and SharePoint content types, using SharePoint as the gateway to the other Microsoft Office products. This was an important consideration, as the clients required that all of the native SharePoint functions such as connect to Outlook, export to spreadsheet, and open with access were available to perform on the CTMS data. This would not have been the case if we’d used business data catalog (BDC) or a user-defined function (UDF). One of the primary use cases for these solutions was providing the master CTMS site visit calendar, action items and site visit report templates to site monitors in Outlook. This allows them to access valuable CTMS information using a familiar interface and while offline (i.e. in the basement of a hospital, surrounded by radiology equipment, where even a WAN card won’t connect). This approach significantly increased user adoption as site monitors weren’t required to learn new software; also reducing training costs as well as on-going support expenses, resulting in faster return on investment.
Below are two white papers that may help further this CTMS and Microsoft Office industry discussion:
I’m also always happy to discuss this in further detail. Please feel free to respond to this blog post with comments, questions, your own CTMS experience, etc.