Bigger, faster, better connected

With technology and data handling becoming increasingly critical to clinical trial success, we thought we’d repeat what we did last issue with a roundup article, but give you a new trio of recent developments on such fronts.

Quintiles and Quest Diagnostics form joint venture

RESEARCH TRIANGLE PARK, N.C. & MADISON, N.J.—Quintiles and Quest Diagnostics have signed a definitive agreement to form a global clinical trials laboratory services business. By combining the clinical trials laboratory operations of two industry leaders, the new entity aims to provide customers with the depth of capabilities and end-to-end clinical trial laboratory services required to succeed in the increasingly complex biopharmaceutical industry. The new entity is said to “offer a compelling value proposition to solidify its position as the second-largest central laboratory services company in the world,” the companies noted.

Clinical, scientific and statistical excellence is becoming increasingly important for successful laboratory work as part of the regulatory approval process. To meet these needs, the new entity will draw upon the deep scientific, medical and data expertise of Quintiles and Quest Diagnostics, which together have a team of approximately 3,500 medical doctors, Ph.D.s and biostatisticians as well as cutting-edge experience, expertise and capabilities in the areas of genomics and precision medicine.

The new entity also will leverage a number of additional resources from the broader Quintiles and Quest Diagnostics organizations, including the Quintiles Infosario technology platform and Quest Diagnostics’ data analytics capabilities. Quest Diagnostics draws from 20 billion test results, and Quintiles’ assets include electronic health records representing more than 60 million patient lives and a network of 250,000 clinical investigators.

“This joint venture builds upon the best of Quintiles’ and Quest Diagnostics’ strengths, creating top-quality services for customers,” said Tom Pike, CEO, Quintiles. “It will join together the scale, expertise and end-to-end capabilities of the broader Quintiles and Quest Diagnostics organizations with a laser-like focus on providing world-class laboratory services that will help improve customers’ probability of success. Quintiles and Quest Diagnostics are already industry leaders with complementary offerings, capabilities and visions to improve patient outcomes and human health. We’re excited about the opportunities ahead of us and the benefits we can provide customers.”

Upon closing of the transaction, Quintiles will own 60 percent and Quest Diagnostics will own 40 percent of the new joint venture.

“We’re thrilled to partner with the world’s leading biopharmaceutical services provider to help customers succeed with their clinical trials and support the pursuit of precision medicine,” said Steve Rusckowski, CEO of Quest Diagnostics. “For Quest Diagnostics, the joint venture model will enable us to generate growth and value from our clinical trials assets while simultaneously strengthening our focus on our core diagnostic information services business.”

Beyond the immediate opportunity in laboratory services support for clinical trials, Quintiles and Quest Diagnostics expect to benefit from opportunities to collaborate in other areas. These include new ways to enhance patient recruiting and retention for clinical trials; speed the validation, development and commercialization of companion diagnostics; enhance support of real-world late-phase studies; and develop new population-health analytics and tools.

New goBalto Activate aims to further accelerate clinical studies

SAN FRANCISCO—goBalto Inc., a provider of cloud-based clinical study startup solutions, has introduced its latest version of goBalto Activate. This first major release of 2015 offers new features that further accelerate clinical study startup.

Recognizing that study startup is more than just documents, goBalto notes that it tailored this new Activate release to include submissions and other key activities and milestones not effectively managed with existing clinical systems. To better optimize the entire startup lifecycle, Activate is said to provide “a complete and accurate picture of status and bottlenecks.”

With more than 1,200 contract research organizations (CROs) and pharmaceutical companies in more than 50 countries using Activate to manage, track and complete study startup tasks, goBalto reports that it has the largest set of proven country workflows and that these workflows meet the expectations of specific country regulatory submission requirements out of the box, so that companies can start their studies in days.

Activate’s new features include expired document management, alerts that highlight opportunities to improve cycle times and track activities and milestones, automated workflows that drive the entire process until documents are ready for electronic trial master filing (eTMF), the ability for sites to complete activities in seconds using the new Activate LITE interface and an application programming interface enhancement to support seamless integration with investigator portals.

There continues to be a steady increase in enterprise Activate usage, with newly added top-20 pharma and biotech companies starting their first studies in Activate. The addition of goBalto’s latest customers represents a 60-percent increase from the same time in 2014.

“Our goal is to continue to support customers who are taking the leadership role to improve study startup,” said goBalto CEO Sujay Jadhav. “We’re constantly looking for the most innovative ways to provide customers with even more time savings, increased visibility and enhanced collaboration. With Activate’s seamless integration capabilities, we’re helping our customers span the entire study startup lifecycle, out of the box, from document approval to eTMF-ready.”

ACRES Blue Cloud IT platform provides shared interface

CAMBRIDGE, Mass.—The Alliance for Clinical Research Excellence and Safety (ACRES) has launched ACRES BlueCloud, the first-phase implementation of a shared multiuser interface to allow sponsors, CROs, regulatory agencies, funding agencies and institutional review boards to access millions of verifiable professional experience and training credentials, enabling long-sought sharing and mutual recognition of those credentials by multiple stakeholders.

The technology also reportedly provides a global integration platform through which stakeholders can “seamlessly access and deploy already-established technology solutions and collaborative data warehouses to support a global system for high-performance accountable research.”

Made possible by a multimillion-dollar technologies and services pledge from ACRES’ strategic ally HealthCarePoint (HCP), a Texas-based healthcare and clinical research networking-technology corporation, ACRES BlueCloud provides capabilities for effortlessly interconnecting parties across the “global clinical research ecosystem.” HealthCarePoint is among several technology companies and standards organizations comprising ACRES’ global Technology Consortium, working to integrate critical technology solutions from multiple providers into a comprehensive shared, universal interface supporting collaboration and interoperability among key stakeholders across the clinical research enterprise.

“We are happy to provide ACRES BlueCloud as part of our common mission to improve efficiency, quality and transparency across this endeavor, benefiting patients and care givers worldwide,” stated Al O. Pacino, president of HCP. “By donating this technology, we can very substantially help ACRES realize its goal to build a collaborative global system for clinical research.” Pacino is also ACRES’ vice president for collaborative network development.

“There is much talk these days about portals and technology solutions to promote safety, quality, efficiency and collaboration in clinical research,” noted Greg Koski, ACRES president and CEO. “Actually, many solutions are already available and proven, but we need a system enabling them to work together. Rather than costly building from scratch, ACRES is leveraging existing technologies through a shared integration platform. ACRES Blue Cloud is a major first step in this direction, and we are very grateful to HealthCarePoint for making it possible.”

Rollout of the ACRES Blue Cloud platform will begin immediately by providing the technology free of charge to clinical research sites worldwide. The network’s single sign-on interface will allow sites to connect with sponsors, CROs, ethics committees and other stakeholders through a unified platform, sharing critical professional and operational information, such as training certifications and other professional credentials. As other provider technologies integrate with the shared platform, additional functionality will be added.

Daniel O’Connor, president and chief business officer of California-based InnovoCommerce, a leading provider of secure cloud-based collaboration solutions for the life-sciences industry, enthusiastically greeted the announcement. “This is a milestone for the drug development enterprise. Global availability of a common platform allowing all players to connect and share information, which also enables access to and interoperability of technologies from multiple providers and users, is huge. ACRES' vision of a shared integrating platform, as opposed to a single proprietary platform, is the foundation for a much-needed global system, one that is taking shape before our eyes.”