SAN FRANCISCO, July 7, 2015 /PRNewswire/ - goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today its latest version of goBalto Activate. The second major release of 2015 offers new features that further accelerate clinical study startup.
"There is intense pressure to speed clinical trials and restrain costs, with Sponsors and CROs continuing to search for ways to automate and reduce the time it takes to get investigative sites up and running," said Sujay Jadhav, goBalto's CEO. "goBalto is the industry standard for study startup, completing the eClinical Stack with full integration to existing CTMS and eTMF systems, enabling business process optimization, oversight and continual process improvements that existing systems don't address."
"The clinical trials industry recognizes that study startup is one of the most difficult areas today resulting in delays and high costs. Our initial research in this area shows that the study startup process is very unsophisticated and inefficient," said Ken Getz, Director, Tufts Center for the Study of Drug Development. "Sponsor organizations are typically struggling to identify and engage a global community of investigative sites quickly; to review and approve regulatory documentation in a timely manner; to manage costs, resources and timelines."
With over 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. Our standard 'out-of-the-box' country specific regulatory business process workflows allow quick site activation, leading to greater cost savings and faster market entry, making valuable therapies available to patients sooner.
"This release illustrates our commitment to our customers as we continue to support them accelerate the development of drugs that save lives and improve the quality of life," said Jadhav. "We now service three of the top 5 CROs and more than two-thirds of the top 20 pharma's, managing their clinical trial documents globally."
Activate customers report improved business performance and a reduction in cycle times by > 30%. New capabilities just released aim to improve project management capabilities and usability, with a focus on enhanced risk management, utilization, business process improvement, and administration. Activate's new features include:
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.