By Clinical Informatics News Staff 

January 25, 2017 | MIAMI—The winners of the Clinical Informatics News Best Practices Awards were announced on Wednesday at the Summit for Clinical Ops Executives, SCOPE, in Miami, Fla. Prizes were awarded to Mytrus, CluePoints, and DrugDev.

The Clinical Informatics News Best Practices awards recognize outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations that manifestly improve the clinical trial process. An expert panel of judges assessed entries looking for solutions that are innovative, and needed in the industry.

“This year’s entries again raised the bar on innovation in clinical trials,” said Allison Proffitt, Clinical Informatics News’ editorial director. “The clinical trials community and industry are so dedicated to improving the clinical trials process for the patients while upholding standards of excellence in drug development. It’s an exciting time.”

The judges named nine finalists, and from that pool chose winning entries in three categories: Clinical Data Intelligence; Study Startup and Design; and Patient Data Management.

Clinical Data Intelligence: CluePoints

Creating the Ultimate Risk-Based Monitoring and Data Quality Oversight Solution

Breaking new ground as an enabling technology for risk-based monitoring (RBM), CluePoints’ Central Statistical Monitoring (CSM) software utilizes statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. Deployed to support traditional monitoring and data management as well as improved “risk- based approaches,” CluePoints’ CSM software can be implemented as the ultimate engine to drive RBM. The value of the solution lies in its ability to identify anomalies in data earlier, offering the opportunity to eradicate issues as they are uncovered, increasing patient safety and reducing risks of data quality or integrity issues when submitting for regulatory approval.

Study Startup And Design: DrugDev

DrugDev Golden Number: Industry-standard unique identifier for clinical trial locations and personnel

DrugDev’s Golden Number is an industry- standard unique identifier for clinical trial locations and personnel that enables drug developers and researchers to run more efficient trials and supports cross-industry collaborations like TransCelerate’s Investigator Registry and the Investigator Databank. The objective of the Golden Number is to provide customers with a universal identifier across all available data sources to drive evidence-based site selection and master data management.

Patient Data Management: Mytrus, Inc.

Virtual Clinical Trials; Accelerating research and reducing data management risk on the ADAPTABLE Aspirin Trial

Utilizing a broad national network of healthcare organizations to pre-screen prospective participants using information in their electronic health records, then inviting them to visit a centralized study website using Mytrus’ Engage virtual trial platform, Duke Clinical Research Institute (DCRI) is able to rapidly engage patients remotely and provide an interactive platform to screen remotely consent trial participants. Once enrolled into the clinical trial, patients are able to create profiles and self report medical histories, concomitant medications, electronic participant reported outcomes (ePRO), Quality of Life and health-based questionnaires, and patient surveys during this two year study. The use of technology and electronic reporting allows study team members to quickly collect, review, and validate patient data and provide real-time input to the sponsor throughout the course of the study via web portals that share de-identified information. It also allows patients to provide their input from the comfort of their own home, office, or wherever they might be by using a Bring Your Own Device (BYOD) platform, further reducing the study costs of supplying dedicated devices to each patient.

Judges for the 2017 awards included Beth Harper, Clinical Performance Partners; Jerald Schindler, Merck; Stephen Fogelson, Develotron; Marina Filshtinsky, Micah Lieberman, and Lee Yuan, Cambridge Healthtech Institute; Craig Lipset, Pfizer; Nancy Mulligan, UBC; and Allison Proffitt, Clinical Informatics News.