AG Mednet, Cardialysis Expand Partnership to Streamline Clinical Endpoint Adjudication and Data Monitoring Processes in Cardiovascular Clinical Trials

USA - English

• USA - English

BOSTON, April 30, 2019 /PRNewswire-PRWeb/ -- Driving advanced research services for cardiology-focused phase II and phase III clinical trials and investigator-initiated studies, Cardialysis is expanding software capabilities by using AG Mednet's Judi suite of clinical trial technologies. The Judi // Adjudication site-upload module will supplement WebCEC 3.0, the Cardialysis in-house tailormade cardiovascular adjudication solution, streamlining data flow between clinical sites and Cardialysis. This partnership further focuses on the implementation of Judi // DSMB, supporting secure collection, distribution and management of clinical trial data.

Cardialysis is a leading academic research organization providing professional services with an exclusive cardiovascular focus. Cardialysis has been instrumental in many of the major advances in the approval of drugs and medical devices currently used in Europe and in the U.S. It is a founding member of the Academic Research Consortium which supports the development of standardized definitions and nomenclature to improve consistency in clinical trial endpoints. In almost 30 years of clinical endpoint adjudication (CEA) activities, it has completed 100+ CEA projects and pioneered a digital CEA solution in 1997, of which the latest version was released early in 2017 (WebCEC 3.0).

Judi // Adjudication is a cloud-based platform built to manage end-to-end clinical event and endpoint adjudication workflows. The platform optimizes tasks while ensuring the quality of the data in the system. Cardialysis will use Judi // Adjudication to automate its endpoint adjudication protocol management, including:

o    Dossier management:
o    Assemble dossiers, CRO-generated notes, translations, queries and de-identify documents
o    Open, respond and close queries to sites and adjudicators
o    Distribute dossiers to individual adjudicators and AROs
o    Retrieve documents from sites
o    Call back dossiers
o    Real-time document/source data submission management:
o    Upload any document type including medical images
o    De-identify documents
o    Fill out smart eCRFs
o    Parse large or combined files into multiple document types

Judi // DSMB provides CROs, sponsors and regulators the ability to have every communication between participants, as well as all documents and summaries, in a single, secure, audited environment during data safety monitoring board activities. The platform is designed to automate and simplify a process that has previously been unsecure and complex. Cardialysis will offer Judi // DSMB to allow for:

o    Secure collection, transfer and storage of core data in any format
o    Distribution of blinded and unblinded reports
o    Ability to manage all real-time communications related to DSMB business in an auditable, 21 CFR Part 11 compliant manner

"Data integrity is critical for the success of randomized clinical trials, a complex mandate that includes quality in data collection, management and distribution," said Dr. Ernest Spitzer, director of clinical endpoint adjudication and data monitoring at Cardialysis. "This partnership ensures that clinical trial data collection is secure and efficient. We've had tremendous success in implementing AG Mednet's imaging platform and are confident that supplementing WebCEC 3.0 with the site-upload module of Judi // Adjudication will create an optimal end-to-end solution for sponsors and investigators."

"An expansion of our partnership with Cardialysis demonstrates the push toward data security and efficiency across all aspects of clinical trials. Cardialysis and AG Mednet share a common goal of advancing the clinical trial industry," said Abraham Gutman, president and CEO of AG Mednet. "We are dedicated to protecting sensitive trial data and automating clinical trial processes to combat any issues with data quality."

AG Mednet is a leader in automated solutions to improve data quality in clinical trials. For more information on AG Mednet's clinical trial solutions, visit agmednet.com.

###

About Cardialysis
Cardialysis is a leading academic research organization (ARO) with an exclusive cardiovascular focus providing a full range of clinical research and cardiac Core Laboratory research services. Founded in 1983, Cardialysis is recognized for its opinion-leader expertise, strong academic network and in-depth cardiology expertise and in recent years has significantly expanded its operational activities. The world's top medical device, biotechnology and pharmaceutical companies collaborate with Cardialysis resulting in more than 400 clinical trials conducted up till now, contributing to improved cardiovascular therapies.

About AG Mednet
AG Mednet is the leading quality compliance partner for image data submission and collection, as well as DSMB, endpoint and adverse event adjudication workflows. The company is a proponent of zero-delay clinical trials, and has supported more than 1,300 global imaging trials. Dozens of adjudication protocols are being managed by sponsors and CROs using Judi. More than 60,000 registered users across thousands of investigator sites in more than 80 countries use AG Mednet to submit more than 17,000,000 images per month and managing more than 50,000 endpoints and events in projects sponsored by each of the world's top 20 pharmaceutical, biotech and medical device companies.

SOURCE AG Mednet