SOUTHBOROUGH, Mass.– (BUSINESS WIRE)– Veristat, een full-service Clinical Research Organization (CRO), heeft vandaag aangekondigd dat het een samenwerkingsverband heeft gesloten met Triumph Research Intelligence (TRI). Dat is een bedrijf dat technologie en oplossingen voor gecentraliseerde risico-monitoring (risico based monitoring – RBM) biedt om de kwaliteit en naleving van klinische studies te verbeteren.

Eerder dit jaar heeft de Amerikaanse Food and Drug Administration (FDA) een nieuwe leidraad uitgegeven: de Richtlijn voor Goede Klinische Praktijk (Good Clinical Practice – GCP) van de Internationale Raad voor Harmonisatie (International Council for Harmonization’s – ICH), of ICH GCP E6 (R2). Die behandelt de belangrijkste aspecten van klinische testinefficiëntie en complexiteit. Dat beslaat met name proefontwerpen, beheer en overzicht, patiëntveiligheid, gegevensintegriteit en computersysteemvalidatie.

Veristat Partners with TRI to Provide Centralized and Risk-Based Monitoring Technology to Their Biopharmaceutical Clients

SOUTHBOROUGH, Mass.–(BUSINESS WIRE)– Veristat, a full-service Clinical Research Organization (CRO), announced today that it has partnered with Triumph Research Intelligence (TRI), a global leader providing technology and solutions for centralized and risk-based monitoring (RBM) to improve clinical trial quality and compliance.

Earlier this year, the US Food and Drug Administration (FDA) issued a new guidance known as the International Council for Harmonization’s (ICH’s) Guideline for Good Clinical Practice (GCP) or ICH GCP E6(R2), that addresses critical key aspects of clinical trial inefficiency and complexity. This specifically includes trial design, management and oversight, patient safety, data integrity, and computer system validation.

“I’m excited to work with TRI to deliver enhanced services to our sponsors who are embracing RBM and centralized monitoring in their studies. The ability to quickly identify areas of quality risk and their causes will allow us to target our onsite monitoring activities effectively and focus our efforts on areas to improve data quality and ensure patient safety. Additionally, we will ensure compliance with regulatory authorities,” said Shaheen Limbada, SVP Global Clinical Operations at Veristat.

The FDA guidance encourages the adoption of risk-based quality practices that have the potential to support improved efficiency and patient safety, data quality and cost savings for clinical trials. This prompted a rapidly increasing demand for centralized and risk-based monitoring solutions from both clinical research organizations (CROs) and sponsors. TRI’s RBM technology platform optimizes trial quality by improving data reliability, patient safety, and operational efficiency.

“We’re delighted to partner with Veristat as they are a leading CRO with a global reputation for quality and excellence. In a world of big data, it’s still people that make decisions. Using our technology platform will enable Veristat and their sponsors to make better-informed decisions faster,” said Duncan Hall, CEO and Founder of TRI.

For more information, visit http://www.veristat.com and http://www.tritrials.com.

About Veristat

Veristat is a clinical research partner focused on supporting biopharmaceutical firms as they advance their therapies through the clinical development and regulatory submission process. Our work delivers meaningful clinical impact and our regulatory submission expertise is unrivaled in our industry. Veristat teams have worked on over 70 regulatory submission projects that have resulted in more than 40 submission approvals to date from various regulatory agencies around the world. Over the last 5 years alone, nearly 8% of new molecular entities (NMEs) approved by the FDA were supported by Veristat teams. Veristat aims to propel even the most complex submissions to successful regulatory conclusions so that new therapies become available to improve and save lives. For more information, visit http://www.veristat.com.

About TRI

Triumph Research Intelligence (TRI) is a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials. It is based in Cambridge, UK, and Raleigh, North Carolina in the United States. Over 10% of failed NDA submissions are due to data quality and cost the industry hundreds of millions of dollars each year. TRI was founded in 2011 by CEO Duncan Hall to directly address this issue. TRIs products, solutions and services are designed to optimize clinical trial quality by improving data reliability and at the same time increase patient safety and operational efficiency.

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Contacts

Veristat:
Gillian Dellacioppa, +1 508-306-6336
Marketing Director
gillian.dellacioppa@veristat.com
or
TRI:
Neil Watkins, +44 (07710) 420477
Head of Marketing
neil.watkins@tritrials.com