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To increase clinical trial quality and minimize deviations, Nimblify’s platform now gives sponsors the ability to build and review their protocols in a standard calendar format and make them available to their sites through the exchange.
MADISON, WI. – Nimblify, Inc., a clinical trials technology company, announced its latest offering, the
Protocol Calendar Exchange
, is officially open to all sponsors in the industry. The platform includes a robust repository of pre-built, pre-reviewed protocol calendars available for sites to download into their clinical trial management system (CTMS), which is the site’s preferred tool to drive day-to-day operations across all their trials. Each calendar is a structured representation of a protocol’s schedule of events in a standard format that carefully reflects the sponsor’s intent. These centrally built calendars can be shared and reused by multiple sites on the same protocol. This consistency across sites improves the quality and safety of study conduct, minimizing deviations. Since its inception, Nimblify has built more than 2,500 unique protocol calendars as part of an ever-expanding library, with over 3,400 calendars downloaded by research sites. Following early success working with a variety of sponsors, now any sponsor has the ability to directly build and review their protocols in the platform before making them available to their sites through the exchange. This standards-based approach benefits sponsors in unprecedented ways and helps solve a critical issue.
The need for standardization
For every protocol, a sponsor sends each participating site a large file of the protocol document. This file often includes unstructured representations of the schedule of events and procedures, instructions buried in the footnotes and modifications reflected elsewhere in the protocol document. Each site creates the protocol calendar from scratch using the sponsor’s document, leaving calendar builders at every site to interpret the protocol in his or her own unique way. Based on the size of the trial and the number of participating sites, this reinterpretation can happen from ten to a hundred times. Hence, the amount of variation across the protocol quickly escalates. The lack of consistency across sites can lead to subsequent deviations and violations during the participant lifecycle on the trial. Such deviations from the calendar can result in missed visits and inaccurate treatments, creating non-trivial safety concerns for participants and regulatory compliance challenges for the site and sponsor.
Creating a source of truth that provides downstream benefits
The Protocol Calendar Exchange ensures a protocol calendar is built once and can be used many times by all participating sites. This not only eliminates the need for each site to replicate build efforts, but it also guarantees the schedule of patient visits, tests and procedures is consistent and accurate across sites. Having a standard calendar available up-front reduces startup times while helping sites with tasks such as forecasting participant visits, budgeting, coverage analysis, invoicing, payment reconciliation and more. Spending less time on all of these activities ultimately allows treatments to get to market faster while reducing the overall cost of clinical trials. The Protocol Calendar Exchange was developed and guidelines were established in collaboration with a variety of research organizations. Nimblify worked with Washington University School of Medicine for a period of nine months to build out over 600 study calendars. Dave Mulvihill, IT Project Manager, commented, “Providing clear guidelines for how details from protocol documents would be extracted, interpreted and applied toward the creation of calendars allowed us to enjoy extremely fast turnaround times. As such, local study teams’ review cycles were expedited which ultimately led to shortened activation timelines.” Nimblify has developed a dedicated group to lead this initiative made up of experienced study coordinators and CRAs. “The Calendar Team is very good at picking up visits in complicated cancer studies where visits are not in one straight flow,” said Magdalene Lindenbaum, Project Manager, Clinical Trials Administration Office, UCLA. Nimblify was able to build out a robust calendar library by working side-by-side with its customers. “Working with the Calendar Team always felt like a collaborative effort and never like a vendor just providing services,” added Mulvihill.
Initial success with sponsors
Nimblify began working directly with sponsors – ranging from national cooperative groups to major pharmaceutical companies – to include their protocols in the exchange. Nimblify built the sponsor’s protocol calendars, which were then reviewed and approved by each sponsor and made available to sites participating on the trial. After verifying a site was on a trial, Nimblify gave each site access to import the protocol calendar into the site’s pre-integrated CTMS environment or provided it in spreadsheet format. The sponsors expedited trial activation timelines while sites decreased the amount of time spent on protocol interpretation and calendar building. After these successful pilots, Nimblify officially made the Protocol Calendar Exchange available to benefit more sponsors in the industry. Nimblify continues to offer the option of building protocol calendars for sponsors. “Sponsors now have the ability to standardize and share protocol calendars across sites participating on the same study, which supports protocol compliance, quality, patient safety and overall consistencies,” said Nimblify Founder & CEO, Shree Kalluri. As more sites use the same calendar, room for error throughout the trial decreases. “The greatest impact on the quality of conduct across sites will be seen when research organizations conform to standards. By building the calendar once and reusing it many times, we gain industry-wide efficiencies,” added Kalluri. Most sites carry out the protocol’s activities using the calendar they build in their site-owned CTMS, as it’s the site’s primary and preferred tool. By leveraging technology already used by research sites, including those using OnCore® Enterprise Research and Allegro® CTMS, sponsors don’t have to force additional software onto the site. To make protocol calendars accessible to all sites, Nimblify will provide APIs for other technology vendors to interface with the exchange. In the meantime, an Excel-based version of the protocol calendar is available. Sponsors can contact Nimblify to get involved with the Protocol Calendar Exchange by emailing
filling out this form
. For more information, visit:
About Nimblify, Inc.
Nimblify, Inc. is a clinical trials technology company dedicated to creating industry-wide efficiencies by connecting stakeholders in clinical research. Nimblify created Participant Payments, a patient-centric payment system, and hosts Research Resonance Network, an award-winning benchmarking tool that uses a standard set of operational metrics and is free for sites. Nimblify also hosts the Protocol Calendar Exchange, a robust repository of pre-built, pre-reviewed protocol calendars available for clinical trial management systems. Spun out of Forte Research Systems in August 2015, Nimblify is a privately held company and is headquartered in Madison, Wis. For more information, please visit