Catapult will provide step function advances in Clinical Trial Data Management with friction-less incorporation of Real-World Data.

Bethesda MD, May 30, 2018 / For Immediate Release / — The Medical Technology and Practice Patterns Institute, Inc. (headquartered in Bethesda, MD) and iClinical, Inc. (headquartered in San Francisco, CA) announced today that they have signed a strategic alliance. The alliance, marketed under the name Catapult, will help healthcare organizations disrupt the medical treatment development cycle and bring life-saving interventions to patients faster and with better evidence than the current frameworks allow. Catapult will combine MTPPI’s real-world data modeling (RWD) expertise with iClinical’s innovative technology platform to create a next generation clinical data management (CDM) solution. “The current CDM operating model involves stringing together various legacy technology solutions to execute clinical trials,” said Dr. Sridhar Byrappa, CEO of iClinical. “This adds time and costs to a trial. With the Catapult alliance, we will bring together the processes and the advanced technologies to run faster clinical trials.”

Catapult will bring the following solutions to market:

  • Fully digital trial data management platform, from CRF creation through clinical protocol database lock
  • Vendor neutral infrastructure that integrates seamlessly with legacy systems, open source applications (Redshift), or client specific platforms (iClinical)
  • Real-time data cleaning using API commands, SQL analysis, and machine learning (ML) models
  • Blockchain solutions that will allow stacking of trial data and processes on a distributed ledger. This will create a decentralized consensus mechanism that ensures transparency for regulatory bodies and authenticated results.
  • Mobile hardware solutions that deploy Internet of Things (IoT) enabled devices, allowing companies to conduct “site-less” global trials

“The pharma industry is facing headwinds on multiple business fronts. The top line is being pressured by coming patent cliffs and shareholders are putting an increased emphasis on R&D productivity,” said Nicholas Hamilton-Cotter, MTPPI’s Director of Development and Strategic Alliances. “The Catapult alliance will allow MTPPI to put its Causal Inference Toolkit application on a mobile SaaS platform. R&D organizations will be able to deploy a full-stack RWD solution at scale, making step function advances, such as site-less trials, a business reality.”
The alliance will also sponsor the Trial Design 2.0 Center of Excellence (TD2COE). TD2COE will collaborate with biotechnology firms, academic research centers and digital healthcare start-ups to research and design adaptive and innovative trial frameworks that are responsive to evolving regulation paradigms such as the IMDRF’s Software as a Medical Device (SaMD) guidance and the FDA’s Digital Health Software Pre-certification (PreCert) Program. “The Catapult alliance will allow us to look at drug development problems in a holistic fashion and come up with bespoke solutions,” said Dr. Byrappa. “The solutions will be secure, scalable and fully compliant with FDA/EU regulations. Our goal is to get life-saving drugs to market sooner and at a lower cost”

For more information on the Catapult alliance contact either info@mtppi.org or support@iclinical.co

2018-05-30T15:48:44+00:00