New European Clinical Trial Regulations aim to Reduce Administrative Burden and Costs
20 Oct, 2015, 18:00 BST
Industry leader in clinical study startup announces harmonized workflows for clinical trial expediency and compliance
SAN FRANCISCO, Oct. 20, 2015 /PRNewswire/ -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today compliance with new European regulatory directives aimed at creating an environment that is favorable for conducting clinical trials across the European Union.
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The new Clinical Trials Regulation (CTR) EU No 536/2014, scheduled to come into force in May 2016, aims to harmonize the requirements for clinical trials while ensuring the safety of clinical trial participants, the ethical soundness of trials and the reliability and robustness of data generated.
The new regulation replaces the EU Clinical Trial Directive 2001/20/EC, which the European Commission acknowledges contributed to a significant fall in the number of clinical trials conducted across Europe, and increased the administrative burden and time taken to launch new trials by 90 percent.
Intrinsic to the new regulations is the simplification of procedures, which are streamlined to remove duplication and delays in launching new clinical studies, the introduction of a lighter regulatory regime for trials conducted with medicines that have already been authorized, and the simplification of reporting requirements.
"There is intense pressure to speed clinical trials and restrain costs, but inefficiencies tied to duplicated or disparate processes and systems, paper-based methods, and lack of regulatory harmonization across European Member States have stalled these efforts," said Sujay Jadhav, goBalto's CEO. "The current status of clinical trials has encouraged industry leaders, to embrace cloud-based solutions. Our study startup methodology aligns with the goal of faster development by significantly impacting cycle times, leading to greater cost savings and faster market entry."
Activate customers report improved business performance and a reduction in cycle times by 30-plus percent. With more than 2,000 pharmaceutical and CRO users in more than 60 countries using Activate to manage, track, and complete study startup tasks, goBalto has the largest industry-proven set of country workflows – allowing for quicker site activation. These "smart" workflows guide work and help standardize global processes – making valuable therapies available to patients sooner.
About goBalto
goBalto develops next-generation solutions that simplify and accelerate clinical study startup in the pharmaceutical, biotechnology, and medical device industries. Our management team has over 100 years of combined experience in the life sciences industry and enterprise software implementation. Our team has worked for such companies as Amgen, Genentech, Quintiles, Roche, Johnson & Johnson, and Model N. With a proven commitment to customer success, disruption, and study startup optimization, we're changing the way our leading global pharma and CRO customers approach their business processes. Based in San Francisco, California, we have satellite offices in Pennsylvania and Singapore. For more information, visit www.gobalto.com.
Press contact:
Craig Morgan
415.671.4372
cmorgan@gobalto.com
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SOURCE goBalto, Inc.