San Francisco-based goBalto, a provider of cloud-based clinical study startup solutions, has announced compliance with new European regulatory directives aimed at creating an environment that is favorable for conducting clinical trials across the European Union.
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%.
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 goBalto CEO Sujay Jadhav. “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.”