CTMS: Microsoft SharePoint Integration
When surrounded by such beauty and energy in Barcelona, who wants to sleep? Having just returned from BioClinica's European User Conference there last week, I admit I'm still reacclimatizing to the UK as I write this.
Last year's event was held in Cologne, another tremendous experience. I always look forward to the user conferences as they're a great way to catch up with my clients face-to-face – and an all in one inspiring place. We tend to get a nice mix of long-established pharma and CRO customers, many who use multiple products, as well as those new to our clinical trial technology and services.
ClinTec's Selection of OnPoint CTMS
Several organizations that have implemented OnPoint CTMS within the last year shared their experiences, including ClinTec International. Heather Thomson, Director Global Clinical Operations and Zaynah Jamieson, Clinical Project Analyst talked about their decision to select OnPoint in April, 2014, following an evaluation of five CTMS systems.
ClinTec, an innovative medium-sized CRO with a global reach, operates in more than 50 countries. The company provides full service support to the pharma, biotech, and medical device industry and prides itself on offering a range of innovative technologies. Their initial interest was finding a CTMS solution to further extend and enhance their offerings to sponsors.
In evaluating CTMS systems, ClinTec found it especially attractive how OnPoint ties directly into Microsoft SharePoint. This proved key as SharePoint was recently selected as their enterprise intranet solution to improve and standardize internal activities, as well as management and reporting of studies/projects. ClinTec also saw an important value-add feature in BioClinica's sponsor-specific 21 CRF Part 11 electronic signed MVR. (More on The Making of an MVR with Microsoft Office Smarts here).
Heather and Zaynah also said they like our CTMS frontend as it allows a high degree of customization via SharePoint in terms of what data is made available and to whom, and how the data looks. This was crucial to enabling their many sponsors to view data in a way tailored to them and their individual study. Another feature ClinTec finds valuable is the "real-time" factor of critical data. This drastically cuts down on weekly spreadsheets and the manual work that goes into preparing them.
Collaboration with BioClinica
Heather and Zaynah discussed the deployment process that began with information gathering in our "discovery phase." They explained how we walked them step-by-step through system features while capturing their existing process. They were shown how to leverage the business tools inherent in the CTMS and potential customizations to accommodate sponsor-specific SOP's, workflows, needs and so on.
BioClinica's Jeremiah Rehm demonstrates the latest features of OnPoint CTMS to the Barcelona audience.
Following this we provided ClinTec a series of configuration and design documents that specify how OnPoint, SharePoint and integrations (EDC/eTMF/ etc.) and custom reporting all come together in one centralized place. They were given an opportunity to review and provide input before giving an official go-ahead to start the build.
Next up, Heather and Zaynah explained how after we had built the test environment, they performed a risk analysis to determine what kind of "validation" would be required. Due to the configurable nature of OnPoint and SharePoint, they decided a streamlined validation was indeed in order whereby internal validation led by CPM's and CRA's would determine "usability" and accuracy of the setup. By using primarily BioClinica's standard frontend offering, the entire deployment process was condensed to a few months, allowing ClinTec to go live with their new CTMS earlier this year.
Finally, after describing their goal to use OnPoint CTMS for all of their studies, Heather and Zaynah hinted toward future plans. They are keen to take advantage of several new features in the next OnPoint release available soon, and other enhancements to the already feature-rich CTMS, due in Q3.
Looking across our technology suite, several attendees expressed interest in our Compass risk-based monitoring solution. As a member of the CTMS team, it is especially rewarding to bring yet another value-add to the table, this one in the way of two-way communication between the two products. While Compass can be used to calculate the monitoring required, OnPoint CTMS can be used in scheduling study-specific "intelligent" monitoring plans.
Such a busy year for both ClinTec and BioClinica, sitting down next to the Mediterranean to enjoy a nice meal and a glass of wine together under a glowing Barcelona sky was the perfect way to toast the fruits of our collaboration.