Bioclinica Launches RTSM Platform

Predictive supply planning, working IRT study protocols in 72 hours, and integration across the clinical supply chain support industry demand for greater speed, accuracy and agility

Doylestown, PA - Bioclinica eHealth Solutions division, which provides an agile ecosystem and domain expertise for sponsors and CROs to speed clinical development, has released the industry’s only purpose-built, end-to-end, configurable randomization and trial supply management (RTSM) software platform. Bioclinica AGILE RTSM provides seamless clinical supply forecasting and management together with IRT to meet the industry’s demand for greater end-to-end efficiencies in the face of increasing time, cost and resource constraints. The flexible, intelligent RTSM platform combines the latest release of Bioclinica’s Trident Agile IRT and the advanced Optimizer clinical supply forecasting and management software to significantly cut time, effort and cost for even the most complex global trials.

“Traditional, siloed and heavily customized systems create significant efficiency gaps, with costly re-work and drawn-out timelines,” said Bioclinica eHealth Solutions President Mukhtar Ahmed. “Our customers are able to view working IRT studies from their protocols in as little as 72 hours, and implement, test and deploy within 7-10 days. Because the RTSM system also integrates with clinical, manufacturing and ERP systems, customers are reducing drug waste and study costs by millions of dollars, and identifying changing trial conditions months in advance to reduce patient and study risk.”

The Bioclinica AGILE RTSM platform provides real-time visibility and reforecasting capability based on study actuals. By combining Bioclinica Optimizer supply management functionality with Trident Agile IRT, clinical operations personnel and clinical supply managers can easily create and compare supply plans, accurately predict demand months in advance, and manage supplies with the ability to analyze study requirements in real time − helping detect and prevent potential supply issues.

Bioclinica’s global expert services teams are skilled in implementing the Agile RTSM methodology, which involves adaptive planning, evolving development and the use of functional software, rather than the development of specification documents prior to the study build. Study managers can evaluate working software and provide immediate feedback − resulting in a faster sign-off and approval process, as well as a study that precisely matches the protocol and study objectives.

Integration across the clinical supply chain and development process enables Bioclinica’s customers to:

• Create and compare supply scenarios − before, during or following the development of the study protocol − against trial objectives such as schedule, cost and feasibility to determine the optimum supply strategy

• Accurately assess drug demand at both the study and program level well in advance of trial start, and provide finished goods to API
• Design, build, implement, test and deploy protocols in as little as two weeks, with an integrated supply strategy
• Conduct fast, accurate patient randomization based on protocol design
• Implement an integrated, optimized RTSM design to get the right drugs to the right sites and patients at the right time
• Utilize continually updated trial actuals in the integrated RTSM study to quickly identify and adjust enrollment rates and supply needs
• Reduce time, effort, and cost for drug destruction and reconciliation through continually updated supply plan and reduced waste
• Conduct database lock quickly and with significantly lower cost and effort, and with higher quality data, due to continual optimization throughout the study

“With this latest release of Trident Agile IRT and its integration with Optimizer, Bioclinica offers a one-of-a-kind AGILE RTSM platform to deliver far greater efficiency, together with expert services to support any customer and any trial, anywhere in the world,” noted Ahmed.

About Bioclinica
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging & Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises the eClinical Solutions platform; Financial Lifecycle Solutions; Safety & Regulatory Solutions; Strategic Consulting Services; App xChange Alliances; and eHealth Cloud Services. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment services, and a post-approval research division. The Company serves more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia.

Learn more about the AGILE RTSM Platform online, in the Bioclinica blog and on Bioclinica LinkedIn and Twitter channels. Watch the Agile IRT video.