Emerging biopharmaceutical organizations face a growing number of regulatory requirements and, due to increased competition1, acute pressure to speed time to market. Today, Oracle Health Sciences announced that 93 of these emerging biopharma organizations worldwide have become new customers in the past year, adopting Oracle Health Sciences solutions to succeed in this rapidly evolving market and deliver drugs to patients faster.
Biopharmaceutical organizations, including sponsors such as Accera and NewLink Genetics and contract research organizations (CROs) FMD K&L and 4C Pharma Solutions, selected Oracle Health Sciences solutions to manage their end-to-end clinical trial processes, boost clinical development productivity, facilitate compliance, and build scalable, affordable platforms for growth.
“Oracle has long been a trusted partner working alongside smaller, emerging firms by developing innovative solutions to help them grow,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences. “Our industry-leading clinical development, management, and safety solutions deploy rapidly and scale on demand, empowering emerging biopharmas to optimize clinical productivity, focus resources on innovation, and manage critical regulatory requirements with confidence.”
With the robust functionality of the Oracle Health Sciences suite of industry-leading cloud solutions2 such as Oracle Health Sciences InForm, Oracle Health Sciences IRT, Oracle Argus, Oracle’s Siebel Clinical Trial Management System, and Oracle Health Sciences ClearTrial Plan and Source Enterprise Edition Cloud Service, these emerging organizations can now optimize productivity and navigate complex regulatory compliance requirements with ease.
FMD K&L adopted Oracle Health Sciences InForm to help ensure data accuracy and efficiencies.
“We are dedicated to providing high-quality results to get our clients’ drug or medical products approved quickly,” said Dr. Xin Ke, president, FMD K&L. “Oracle Health Sciences InForm is a proven, industry-leading clinical data management system that enables us to raise the standard of excellence through accuracy and consistency on a continuous basis. Additionally, the ability to collaborate with Oracle on developing industry standards and implementation best practices has been invaluable in improving the quality and efficiency of our services.”
The Oracle Health Sciences cloud platform also provides an efficient model for predictable costs. Accera, a biotechnology company focused on conditions affecting the central nervous system, uses cloud-based Oracle Health Sciences ClearTrial Plan and Source Enterprise Edition Cloud Service to model scenarios for future trials.
The solution helps Accera to communicate the implications of different scenarios to investors and other stakeholders. It also gives Accera a benchmark for cost comparisons, and helps with financial projections and forecasting for each scenario. This allows Accera personnel to use time and resources more efficiently in the critical planning stages of their clinical development programs.
4C Pharma Solutions and NewLink Genetics use Oracle Argus Safety to gain greater insight into product-safety issues, improve productivity, and streamline safety reporting.
“As the life sciences industry becomes more regulated in reference to drug safety, we believe in providing customized, reliable, cost-effective, and global solutions while building long-lasting relationships to provide a great experience,” said Yathendra Madineni, M.D., CEO, 4C Pharma Solutions. “We build with trust, prove with quality, and truly make our partners’ requirements our passion. With Oracle Argus Safety solutions, our team can help our partners focus on research and innovation while we take care of the rest.”
NewLink Genetics is a biopharmaceutical company focused on discovering, developing, and commercializing immuno-oncology products that activate the body’s immune system to identify and attack cancer cells. By implementing the centralized database within Siebel Clinical Trial Management System, NewLink Genetics can manage its clinical trial activities and improve relationships with investigators, from early to late-stage studies.
“We develop multifaceted treatment strategies and several immuno-oncology agents through clinical trials enrolling patients at sites worldwide,” said Eugene P. Kennedy, M.D., vice president of Clinical and Medical Affairs, NewLink Genetics. “As we push forward to bring much needed treatment options that will revolutionize the way we treat patients with cancer, our team utilizes Oracle Health Sciences solutions for real-time visibility into our operational performance and regulatory compliance requirements.”
By offering a tailored business model to address the unique needs of the emerging biopharmaceutical market, Oracle Health Sciences provides these emerging firms with access to an innovative, affordable, and best-of-breed suite of e-clinical solutions. Further, the Oracle CRO Advantage program provides CROs serving the biopharmaceutical sector with a portfolio of integrated technologies; business development, sales enablement, and training solutions; and joint marketing opportunities that can enhance market success.
Contact: Mary Tobin - O’Keeffe & Company
P: +1 503-658-7396 - E: mtobin[.]okco.com.
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1. DiMasi JA, Faden LB. “Follow‐on Drug R&D: New Data on Trends in Entry Rates and the Timing of Development,” Tufts Center for the Study of Drug Development Working Paper, Boston, Mass.: CSDD. September 2009. Accessed March 2015.
2. IDC Health Insights,“Vendor Assessment: 2014 Top 10 Life Science Software Vendors,” Eric Newmark and Alan S. Louie, March 2015.
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