Interventional Concepts and ACRES Announce Alliance for Colombia

Interventional Concepts, a leading clinical research organization for innovative pharma, biotech and medtech development-stage companies proposing to conduct clinical trials in Colombia, and the Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector non-profit operating in the public interest and committed to transforming the global clinical research environment, have announced a Strategic Alliance, joining Interventional Concepts with current ACRES Allies in their efforts to build ACRES’ shared global clinical research system.

In addition to contributing expertise to ACRES Site Accreditation and Standards Initiative (SASI), Interventional Concepts will work with ACRES and other stakeholders to create ACRES-Colombia, an endeavor that will help link Colombia’s clinical research capacity and stakeholders to the world.

Interventional Concepts, dedicated to life science innovation, has been providing clinical trial regulatory, operational and logistics support since 2010 to development-stage life science startup companies looking for cost-effective clinical research sites in Colombia capable of conducting early-stage human studies. Strategically located close to the US East Coast and sharing the same time zone, Colombia has a free trade agreement with the US and a predictable national regulatory pathway for clinical trials—30 days for medical devices and 60 days for drugs, the fastest in Latin America. It has the healthcare infrastructure and business environment necessary for clinical trials—including the highest ranked hospital in Latin America, over 120 ICH GCP-certified sites and a population close to 50 million with universal healthcare coverage.

Interventional Concepts will work with Colombian institutions, organizations, and companies to set up an ACRES national affiliate in Colombia. ACRES-Colombia will create mechanisms to facilitate appropriate contact between ACRES and Colombian academic institutions, regulatory agencies, and professional associations and to identify opportunities to further develop ACRES-related initiatives. It will promote an all-encompassing system for clinical research in Colombia to ensure the quality, safety, and ethical conduct of trials, including site accreditation, qualification, and certification according to globally-acceptable standards and the communication mechanisms needed to address site-specific needs.

ACRES brings together stakeholders from across the international clinical research eco-system to collaborate on building a much-needed, shared global system for safe, high-performance, clinical research. “Efforts to enhance clinical research capacity and quality in Latin America are very exciting, and Colombia has stepped forward to take a leading role. We are delighted to be working with our colleagues there since a global system only works if it embraces, mobilizes and unifies local resources,” noted Greg Koski, ACRES Co-founder and CEO.

Julio G. Martinez-Clark, Interventional Concepts’ Chief Executive Officer stated, “We look forward to using our experience and expertise to further advance the international expansion of ACRES endeavor to create a collaborative global system for clinical research into Colombia; the first ACRES initiative in Latin America!”

"Bogota welcomes ACRES-Colombia as a catalyzer to transform the local clinical research sector into one that is internationally competitive and aligned with ACRES' vision to build a global system for excellence in clinical research based on the values of Integrity, inclusiveness, innovation and implementation," said Diana Gaviria, Executive Director of Connect Bogota.

The Alliance for Clinical Research Excellence and Safety (ACRES) has endorsed the standard clinical trial agreement (CTA) template created by Model Agreements & Guidelines International (MAGI), striving to break one of the primary bottlenecks in research study startup, the contract negotiation process. In 2004, MAGI initiated a collaborative effort to create a CTA template that would be widely accepted, a significant challenge given the diversity of sponsors, sites and CROs in the industry.

"ACRES is all about like-minded, systems-focused organizations and people working together and leveraging the good work being done across the clinical research landscape. Our collaboration with MAGI is a good example, capitalizing on the valuable work done by this multi-stakeholder group over the past few years to create a tool set that benefits everyone. This is critical since every day of delay is a very costly impediment to the development and availability of new medicines," said ACRES CEO and co-founder, Greg Koski.

ACRES collaboration with MAGI is one of many bringing a collection of open-source tools to sites, CROs and sponsors to increase efficiency, promote standardization and facilitate the start-up process for clinical trials, all of which will result in significant savings in time and money while enhancing site productivity and sustainability, as well as quality. The clinical trials contracting process is challenging for all parties involved in the clinical research endeavor and a "master file" approach to establishing clinical trials agreements represents a significant advance over previous approaches.

In addition to creating the 11-page CTA template, MAGI has educated industry professionals about CTAs and certified Clinical Research Contract Professionals (CRCP).
“Real estate lawyers can negotiate $30-million transactions in three hours, while we spend three months negotiating $30,000 transactions. There is now a general consensus that the time for a standard CTA template has arrived. Other model CTA initiatives have recently emerged, which we welcome as part of the process of reaching an industry-wide consensus. We can agree to save lives,” added Norman Goldfarb, MAGI Chairman.

MAGI joins the growing list of nearly 200 organizations and individuals that are teaming up with ACRES and each other worldwide on diverse collaborations to improve the safety, quality, transparency and cost-effectiveness of the clinical research undertaking and to accelerate medicines development.

Despite a decade of numerous disruptive, innovative or transformative efforts attempted by the enterprise, serious challenges remain and progress has been limited by the failure to transparently connect and integrate these efforts. ACRES is working to overcome these limitations by providing an inter-connected, integrated, transparent, multi-stakeholder collaborative systems approach, and welcomes MAGI’s thoughtful and inclusive approach and innovative solutions.

GuideStar Clinical Trials Management, a company providing support services and strategies for clinical research programs around the United States, and the Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector, non-profit organization building a multi-stakeholder-driven integrated global system for clinical research, today announced their partnership to expand site accreditation and uniformity across the clinical research community to promote and reward excellence.

As a Strategic Ally, GuideStar will collaborate with ACRES on its Site Accreditation Standards Initiative, a project to promote professionalism and sustainability among sites conducting research. The initiative—currently assembling teams across multiple performance domains including: patient and subject engagement and protection; site personnel; research integrity; facilities; information systems and data management; management and administration; as well as quality management—focuses on collecting and developing standards for research sites. It also is establishing independent third-party accreditation and offers opportunities for research sites to undergo self and peer evaluations.

GuideStar is knowledgeable in research operations from years of experience in the industry and working with nearly 100 health systems, hospitals and academic medical centers and will lend its expertise, including best practices, to the ACRES initiative. GuideStar will collaborate with other ACRES Allies in creating site-sustainability standards, registration of sites in a global network, site optics for self-review, and third party oversight of accreditation.

Shirley Trainor-Thomas, Chief Marketing Officer for GuideStar, expressed her enthusiasm about the partnership and the potential it brings. “As a clinical research services provider, the GuideStar team constantly strives to bring our clients guidance to optimize their research programs,” comments Trainor-Thomas. “By partnering with ACRES, we will contribute the solutions and best practices that promote sustainability for research sites around the globe. We are excited to join others in the industry in playing a role in this very important initiative for research sites and patients alike.”

Greg Koski, ACRES Co-founder and CEO, added, “There can be no global system for clinical research without well-prepared clinical research sites, sites of excellence. To create a world of high-performing professional sites we must invest in them and provide both incentives and rewards for their efforts. It is imperative for everyone that sites be given the tools and resources to help them achieve these goals, assistance which GuideStar is wonderfully qualified to give and we wholeheartedly welcome them to our ACRES group of Allies.”

The Alliance for Clinical Research Excellence and Safety (ACRES), the global public-interest collaboration building a comprehensive system to transform clinical research, today announced a major second step toward full implementation of a multi-stakeholder shared information technology platform.

Technology solutions to enhance clinical trial performance are multiplying rapidly, but their usefulness is limited by their lack of connectivity and inter-operability. The new platform, dubbed Apollo, provides a shared infrastructure to support the functional integration of existing technologies, including electronic health records (EHRs), electronic data capture (EDC) systems and clinical trial management systems (CTMS), and to enable data exchange and aggregation critical for development and implementation of “big data” analytics essential for next-generation methods for remote monitoring and auditing, real-time pharmacovigilance, and continuous quality improvement enterprise-wide.

The first phase of the ACRES global IT platform, built on the BlueCloud® 2.0 Networking Technology developed by ACRES’ Austin-based strategic ally HealthCarePoint, provided a common platform for users worldwide to share vital research study documents, including training documentation and verifiable professional credentials essential for study start-up.

With nearly 1,000,000 current member-users in healthcare, research, and industry globally, the BlueCloud® is already benefiting sponsors, CROs, investigators, research sites, regulatory agencies and ethics committees worldwide. Now, the second phase of this global collaborative platform, spearheaded by ACRES strategic partner HealthIDx, includes initial roll-out of a federated trust framework for secure enterprise-wide identity management and single sign-on access to multiple end-user applications on the ACRES Apollo platform.

Apollo utilizes a proven cloud-based integration platform—originally developed by Detroit-based Covisint to support the complex supply chain, distribution and marketing logistics of the automotive industry—to enable seamless connectivity and inter-operability of multiple applications across the industry’s diverse stakeholders, including sites, sponsors, CRO/SMOs, regulatory agencies and supply chain providers and ethics committees.

“We are delighted to be working with ACRES and its many allies in this important effort,” said J. Scott Lowry, Founder and CEO of HealthIDx. “In this next phase, which includes secure cloud-based data exchange, aggregation, visualization, and analysis, we are addressing critical challenges of security, multi-user identity management, and fine-grain access control.” Lowry further noted that several technology applications, including the BlueCloud®, have been integrated via open APIs onto the ACRES Apollo platform and more such integrations are planned, including platforms of other organizations, thereby extending their power, connectedness and effectiveness.

“The ability to acquire and exchange data seamlessly among a wide array of EHR, EDC and CTMS platforms within a secure cloud-based environment and move them into shared data vaults where they can be used in real-time will support clinical research performance, quality, safety and oversight as never before,” said Greg Koski, ACRES co-founder and CEO. “Apollo provides the ability to achieve true connectivity among the many applications already in use, as well as new applications being developed, across the entire drug development and clinical trials endeavor, saving time and money for all, while creating innovative opportunities for creativity, efficiency and effectiveness.”

“This is a collaborative effort,” added ACRES COO Matt Whalen. “Rather than create a proprietary platform, ACRES is deploying a robust integration platform that can connect all stakeholders, whatever applications they currently use, in a timely and cost-effective manner. The power of this approach lies in what can be done through the application of soft systems engineering and the use of standards developed by organizations like OASIS, ICE, CDISC, GS1 and SAFE Biopharma.”

The Apollo platform also incorporates an “app store” to take advantage of the several technologies and point solution capabilities available to users, working in parallel with second-level integrations of EHR, EDC, CTMS and data management systems. A live demonstration of the Apollo’s robust systems capabilities for multiple high-value use-cases is planned in the second quarter of 2016. Additional applications from diverse providers are welcome.

Clinerion, an eClinical technology services provider located in Basel, Switzerland, and the Alliance for Clinical Research Excellence and Safety (ACRES), a Cambridge, Massachusetts-based non-profit organization operating in the public interest and dedicated to building a global system to enhance quality, safety, integrity and operational effectiveness in biomedical product development and health research, are pleased to announce their partnership for accelerating patient recruitment and promoting risk-based quality management.

By aligning with ACRES integrated data source capabilities housing valuable study and site information, Clinerion's Quality Risk Radar will be able to significantly extend its support of risk-informed decision making during the clinical planning and execution process and thereby maintain and exceed study quality standards. Risk based Monitoring (RBM) becomes a reality when applying Clinerion's consulting and technology services as they enable all clinical research organizations to start projects quickly and rapidly pilot the new RBM approach and enabling technology by taking advantage of FREE and discounted services that Clinerion has pledged to ACRES.

Clinerion will provide to ACRES real-time access to millions of electronic health records (EHRs) coupled with the use of its Patient Recruitment System to find on average 30 times more trial candidates than conventional screening.

"We are delighted to join the ACRES Global Network and are pleased to make our easy-to-implement, industry-hardened solutions in Risk-Based Quality Management and Patient Recruitment available to ACRES. We do this for free or at very attractive conditions and we are convinced that this will translate into significant progress toward the common goals of enhancing quality and operational effectiveness in biomedical product development and health research," said Ulf Claesson, CEO of Clinerion.

ACRES COO, Matthew Whalen, noted, “Our relationship with Clinerion — as a Strategic Ally offering innovative solutions that already exist — demonstrates our ongoing commitment to improve clinical research processes globally and accountably. We are excited to be going forward as allies”.

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