It’s not often that two clinical data managers who are years apart in their experience feel equally at ease during a clinical trial. But this is precisely what took place at Ancillarie, a support services company that has been serving pharmaceutical and biotechnology companies since 2012. In 2013, seeking an electronic data capture (EDC) system to catalyze their clinical research, they began a collaborative relationship with Medrio. Since then, they have conducted three clinical trials using Medrio’s software – all dermatology studies. Over the course of those studies, both veteran and early-career data managers at Ancillarie have found Medrio’s software to be convenient and user-friendly, and have achieved comparable efficiency in their research.
Medrio bridges the experience gap
Two of the three studies Ancillarie has conducted with Medrio are complete; one is ongoing. The two complete studies were comparable in their size and level of complexity: the first had 830 subjects and enough data to fill about 32,000 pages; the second, 840 subjects and about 28,000 pages. But the ongoing study takes the cake: with 2,400 subjects, approximately 90,000 pages of data will have been processed by the time the study is complete. These figures suggest laborious study setups and lengthy study timelines, and that even with an EDC system, maximizing efficiency throughout the study would require extensive data management experience.
Indeed, Kiran Chitambare, a data manager with seven years’ experience who worked on the studies, was able to keep timelines down despite the study size and complexity. She built her database in just about four weeks, as opposed to the months it often takes data managers to build studies of similar size. This achievement was possible due to a combination of Ms. Chitambare’s extensive data management experience and the user-friendly functionality of Medrio’s software. The Medrio features she found helpful include, but are not limited to:
- The Data Analysis function, which enabled significant time savings by allowing Ms. Chitambare to check her study data in real time
- Dictionary integration, which allowed her to match patient descriptions of adverse events to their technical terms
- Configuration privileges, which greatly enhanced the process of CRF and database design
Overall, Medrio provided all the data management tools that were necessary without requiring the purchase of any separate services from other vendors. Due to Medrio’s simplicity, Ms. Chitambare was able to become fluent in the software in just one day, and encountered no confusion or lapses in functionality during the study. “If I had to choose any EDC for our studies, I would choose Medrio,” says Ms. Chitambare. “The software is a one-stop shop for data managers, with everything we need under one roof.”
But it’s not only Ancillarie’s senior data managers who are able to use Medrio to cut down on study build time and progress through the studies with ease, efficiency, and convenience. An early-career data manager with about 6 months’ experience, Kanchan Phansekar, found Medrio highly beneficial to her work, as well. It took her only a few weeks more than Ms. Chitambare to build the study database, despite the significant differences in their experience. She attributes her success, in part, to the high quality of Medrio’s software training, including the user manual, online training resources, and more. These resources allowed her to handle difficult or complex tasks like setting auto queries, applying skip logic, and others in a timely manner. Other Medrio features made it easy to:
- Set the parameters of the study
- Create new forms and add data to the system
- Grant viewing access to the database to other team members
Aside from the task-specific features mentioned above, there was one major factor that made Medrio fundamentally better equipped to enable both data managers to conduct their studies with speed and simplicity: the absence of required programming. In previous studies, Ancillarie’s data managers have used EDC systems that required them to contract an external programmer to assist with study setup, incurring costs and delays in the process.
Medrio, on the other hand, imposes no such burden on the customer. Data managers can set up the software themselves – an approach Ancillarie found much more sensible, considering their data managers naturally have better insight into how the software will ultimately be used than any outsourced programmer would. This fundamental feature sets Medrio apart from other EDC systems, and allows even data managers with limited experience to save time and avoid headaches on large and complicated studies. Of her experience with the software, Ms. Phansekar said, “Though Medrio was the first EDC I’ve used in my data management career, I became accustomed to it easily, and was able to build my study remarkably quickly. And their user guide and support team were invaluable.”
The impact of the software on these studies transcended Ancillarie’s impressions of Medrio. As an EDC company well-known for its Phase I specialization, Medrio was known, at Ancillarie, to be particularly well-suited to smaller studies. But through their experience with these three dermatology studies, the data managers learned that Medrio offers a fast, simple, and all-around user-friendly experience for studies of all sizes.
Most notably, they learned that Medrio has the rare capability of providing these benefits to data managers of all experience levels. That Ms. Phansekar benefitted from the software’s flexibility and convenience just as much as Ms. Chitambare shows Medrio’s universal appeal. The software is not exclusive or esoteric. It does not assume years of experience. While it offers features that allow veterans to implement strategies developed over the course of a career, it’s also a tool that allows newer data managers to work on the level of their more experienced colleagues. “Medrio’s user-friendly functionality has enabled even our newer data managers to get accustomed to the software easily,” says Amiit Naik, President and Head of Clinical Data Services at Ancillarie. “Here at Ancillarie, we work on a great deal of large, complex studies. Medrio has made it easier for us to build and conduct those studies under strict timeline demands.”
Ancillarie has been a member of Medrio’s partner program since 2015. Both companies hope to continue their fruitful partnership through many future studies.
Ancillarie is an emerging support Service Company based in Toronto, Canada and Mumbai, India. Ancillarie was established in 2012 to provide Biostatistics, CDISC Implementation, CDISC Mapping, Clinical Data Management, Statistical Programming and Medical Writing. Ancillarie also provides Clinical Operation and Phase I/BE services with help of the partnering companies based USA, Latin America and Canada. For details please visit www.ancillarie.com
Medrio offers an integrated eClinical software platform with a fully hosted EDC system. Our revolutionary CloudEDC™ technology features an easy-to-use drag-and-drop interface, allowing study managers to build their studies in days instead of months without requiring any programming. Medrio’s new mobile suite, mSource, supports both event-based and subject-based workflows, offline data entry, and Patient Reported Outcomes (PRO). Although Medrio has extensive experience in all study phases, our m1 application leads the way in early-phase and Phase I trials, with over 500 Phase I trials to date. Medrio costs up to 75% less than traditional EDC solutions. To schedule a demo and learn more about Medrio’s partner program, please submit your information here and a member of our team will be in touch shortly.