ACI Clinical: Supercharging Clinical Trials with Effective Oversight

Andrew MacKnight, VP, Operations at ACI Clinical
In today’s complex clinical research landscape, conducting clinical trials in different parts of the world presents significant ethical, cultural, and infrastructural challenges to researchers and drug development companies. To overcome these challenges, sponsor companies often require high-level clinical expertise dedicated toward oversight and evaluation of clinical trials. ACI Clinical, a specialty service provider to the clinical research industry, is uniquely positioned to provide Independent Expert Committees that can advise clients across the full spectrum of clinical programs. By delivering reliable and trusted information, ACI’s expert committees help researchers make better informed decisions about clinical development and how to approach complex issues in research.

Utilizing an independent group of experts from various therapeutic areas, ACI has formed a powerful network that provides consulting services for a broad range of projects including full service Endpoint Adjudication Committees, Data Monitoring Committees, Safety Assessment and more. The global network is comprised of more than 500 vetted medical and statistical experts. These qualified advisors provide clients with critical insights to enhance the trial integrity. Emphasizing on the importance of expert committees, Andrew MacKnight, Vice President of Operations at ACI Clinical says, “These committees are formed not only to monitor the clinical study but also strengthen the ongoing relationship with our client sponsors to conduct more studies using a systematic, consistent approach around safety signal detection and evaluation of study endpoints.”

With years of experience and having served almost a hundred companies in the clinical development industry, ACI’s expert committees follow a unique approach to address the impediments across clinical trials. In every client engagement, ACI helps the expert committee to understand the strategy and protocol of the study, as well as the committee’s role and remit within that context. To help document this, ACI has created and implemented a “best practice guide” to assist both the sponsors and the committee members to navigate through the critical decision-making processes.
Further, ACI has developed a proprietary Adjudication Information Management System (AIMS®), specifically designed to enable the adjudication workflows in a regulatory-grade technology platform. AIMS® is designed with a simple, user-friendly interface to reduce administrative burden, enabling committee members to focus on their important tasks. “With the help of our AIMS® platform, ACI’s adjudication committees can seamlessly review global trial data, provide their expert assessments, and increase confidence in endpoint accuracy to the scientific community,” asserts MacKnight.

ACI also provides an innovative technology platform, DASH, dedicated to supporting Data Monitoring Committees (DMC) in integrating various workflows. The platform triggers a number of tasks that must be completed and delivered ahead of scheduled DMC meetings, with clear alerts to any items approaching an overdue date. The platform has helped to align internal procedures and keep everyone devoted to meeting timelines across all active projects.

MacKnight elucidates a common scenario for ACI, where one of its clients, a U.S.-based global clinical provider, had difficulty in scaling adjudication activities from their Phase 2 clinical trial to the next phase. With the help of the AIMS® infrastructure, ACI was able to shift the scale from Phase 2 to a global Phase 3 environment, now supporting endpoint adjudication activities for more than 20 individual protocols around the world. This ability to use technology to scale rapidly and activate process-based committee workflows has enabled ACI to provide robust committee support for hundreds of projects across most therapeutic areas.

Along the path of innovation, ACI Clinical continues to roll out new generations of its AIMS® platform with the latest industry-leading features allowing even higher scalability. Concerning expansion, ACI has plans to extend branches across the world to support global client programs and further development of applications that continue to connect clinical trial data with valuable expert opinions to drive informed decision ability.

ACI Clinical

Bala Cynwyd, PA

Andrew MacKnight, VP, Operations at ACI Clinical

ACI Clinical provides specialty advisory services including Endpoint Adjudication Committees and Data Monitoring Committees along with biometrics and safety consulting

ACI Clinical