By Ann Neuer 

March 11, 2015 | The Alliance for Clinical Research Excellence and Safety—ACRES—has announced a collaboration with HealthCarePoint, a healthcare and clinical research networking technology provider and one of ACRES’ strategic allies, to launch ACRES BlueCloud, an integration platform for parties across the global clinical research enterprise. 

Through a multi-million dollar technologies and services pledge from HealthCarePoint, the first phase of implementation of ACRES BlueCloud will allow sponsors, contract research organizations (CROs), regulatory agencies, funding agencies, and institutional review boards (IRBs) to access millions of verifiable professional experience and training credentials. (See, "ACRES to Produce Global Accreditation Standards for Trial Sites")

Greg Koski

Greg Koski, President and CEO of ACRES, explains, “We’re talking about Good Clinical Practice (GCP) certification and personal training records that need to be accessed by various stakeholders—sponsors, CROs, ethics committees, regulators, and patients. Rather than having to repeatedly submit this information in study after study, it will reside on and can be shared from the ACRES BlueCloud collaborative platform.”

This first phase of ACRES BlueCloud will be followed by integration with other functionalities to enable real time quality and performance monitoring and real time pharmacovigilance—capabilities with major benefit for the entire enterprise. Traditional practices have entailed reviewing and reacting to clinical trial data long after they have been collected.

 Al O. Pacino, President and Co-founder of HealthCarePoint, and ACRES’ Vice President for Collaborative Network Development, notes that development of BlueCloud began 13 years ago. It went live two years ago, with a focus on participation by government agencies, universities, and non-profit organizations in the healthcare sector. Currently, more than 700,000 healthcare professionals are affiliated with ACRES BlueCloud, using different technologies integrated into the platform. They represent several dozen pharmaceutical, biotech, and medical device sponsors, more than a dozen CROs and thousands of healthcare provider organizations. Information is shared by users who grant permission for others to access the information.

Pacino explains that clinical research sites typically lack the resources to acquire the needed technology that would facilitate information sharing. In the spirit of collaboration, HealthCarePoint is offering ACRES BlueCloud for free to ACRES’ allies.

“By giving away these technologies, we are totally breaking away from the silos and portals, which make it difficult to exchange information among stakeholders. It’s a strategy to help the industry adopt technologies to eliminate redundancies and waste,” Pacino says. He explains further that ACRES BlueCloud is a global network of collaborations that connect new and established systems using complimentary technology and application programming interface (API) connections, which allow different technologies to seamlessly work together.

Al O. Pacino

Through a web-based process soon to be rolled out, sites may participate in ACRES BlueCloud when they register to become part of the global network. Once a site is a member of ACRES, it can then access a menu that includes BlueCloud and other products and services to enhance performance and sustainability. Sites will create a profile for each investigator that will list his or her qualifications and document training and certifications. To share the information, sites give stakeholders permission to access the system to see and verify the various types of training the investigators have completed.

Current thinking is that key functions such as safety, data quality, and performance are better served by sharing an infrastructure that benefits all of the stakeholders rather than trying to do this in proprietary silos. As a testament to the growing acceptance of this approach, a rapidly-growing number of companies have become allies, representing pharmaceutical sponsors, providers, and professional organizations. Their engagement is critical because, as Koski remarks, “There are many solutions already available, and we need to have a system that allows them to work together. Through ACRES BlueCloud, we can leverage these existing technologies instead of resorting to building from scratch.”

In building a collaborative approach, ACRES is promoting the concept of Accountable Research. This concept follows in the footsteps of the Accountable Care Organization (ACO), which is a group of physicians, hospitals, and other health care providers, who come together voluntarily to coordinate high-quality care for patients. The goal is to ensure that patients receive the right care at the right time, while avoiding unnecessary duplication of services and preventing medical errors. Importantly, when the ACO reaches these goals, it shares in the savings it achieves.

Applying these principles, Accountable Research identifies organizations committed to pro-actively achieving quality outcomes and safety, reining in costs and ensuring that trials are performed in a manner consistent with global standards of excellence. This includes seeking out feedback from patients on what is important to them in a clinical trial, an action meant to improve the patient experience and improve trial performance. Organizations can be recognized and rewarded for performing research in an accountable manner. As Pacino explains, “It is a movement to improve transparency, professional competency, humility, and respect for patients participating in current as well those in past and future clinical trials.”

Going forward, the global integration platform offered by ACRES BlueCloud will be able to support high-performance Accountable Research as part of ACRES’ mission of excellence and safety in clinical trials.