Integrated Resources, an innovative and fast-growing CRO based in Cambridge, Massachusetts, was recently tasked with building a single-ascending-dose Phase I study of a drug to treat a rare disease, Mucopolysaccharidosis type I (MPS I). The CRO is conducting the study with Medrio’s mCore, an all-inclusive product suitable for use in all clinical phases. The study is complex, with two cohorts of patients, and is the first Phase I study conducted by the Sponsor.
Although Integrated Resources evaluated a number of EDC providers, they decided that Medrio was best suited to serve this Phase I study. Two of the features of the software that most impressed the data managers at Integrated Resources were:
- The ability to utilize the software without any programming, which has long been one of Medrio’s strongest standout features.
- The sandbox features, which allowed the data management team to train themselves in using the software.
Need for Speed
In a typical Phase I study, time is of particular importance. Sponsors want studies up and running as soon as possible; the more time is spent on study build, the more expensive a study becomes. In addition, in the clinical research industry at large, there is a push to bring new medications to market on a shorter timeline than has historically been the standard. For all these reasons, Integrated Resources needed to start creating CRFs and move the study to production, and they needed to do it quickly.
Achieving the ideal study build speed would not come without challenges, as this study, more so than others, entailed a significant degree of variability. Depending on the patients’ tolerance to the administered dose (without any SAE), the dosage levels would either be escalated, kept the same, or discontinued for new patients, and the enrollment of new patients in the study would be adapted accordingly. This created a level of complexity that can be difficult to reconcile with the timeline demands of a Phase I study sponsor. Integrated Resources would need a data management software flexible enough to handle the real-time adaptive nature of the trial. Medrio was able to fill this role. The data managers found that Medrio is adaptive and flexible, and thus able to accommodate the complexity of the study design. Of particular utility was the ease and speed with which they were able to import forms from the library.
The Big Payoff
Medrio takes pride in enabling its customers to build their studies in weeks instead of months. And indeed, the software did serve Integrated Resources as a platform for fast-tracking their study build. But in this Phase I study, Integrated Resources went above and beyond, and accomplished something practically unheard of: They started building the study in Medrio at around 10:00 in the morning and finished at around 9:00 that very evening, managing to do in less than twelve hours what many CROs take a minimum of two weeks to do. What’s more, the scale of their production reflected the size of the study: all told, the data management team created 18 visits and 197 CRFs.
A combination of the skill and expertise of Integrated Resources personnel and the utility of Medrio’s software led to this startling achievement. Hitesh Wadhwa, Senior Clinical Data Manager at Integrated Resources, said, “It has always been a challenge to create and update CRFs in less than two to three weeks. For us, that changed with Medrio. I was able to create my first draft of the CRF in Medrio’s EDC, and submit it to the Sponsor in a day.” He added, “We’ve always taken pride in our efficiency, and now Medrio has helped us to take that efficiency to the next level.”
About Integrated Resources
Integrated Resources is a small team specializing in Data Management (DM) services and committed to simplifying the execution of clinical trials. By streamlining the DM process, they believe they can achieve this goal while generating clean & consistent data. For that reason, their team has developed a comprehensive DM setup that enables them to launch clinical trials faster while remaining thorough and cost-effective. For further details, please visit www.simplifyclinicaltrials.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 significantly reduce their study build time 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, with over 500 Phase I trials to date, our m1 application leads the way in early phase and Phase I trials. Medrio costs up to 75% less than traditional EDC solutions.