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ACI to participate in Device Adjudication Think Tank in Washington, D.C.

ACI Clinical will participate in an expert think tank exploring The Role of Adjudication in Medical Device Clinical Trials. The meeting is scheduled for March 11, 2016, at the ACC Heart House in Washington, D.C. The one-day meeting is sponsored by the Cardiac Safety Research Consortium (CSRC) and the

February 9th, 2016|

Patient Engagement in Clinical Research is Growing

From a technical perspective, the beginning of the clinical research process often brings to mind images of scientists in the lab. But long before a drug or device company begins the arduous and uncertain journey to develop a new therapy, it is the patients and their stories that inspire

January 14th, 2016|

New FDA Guidance recommends use of Safety Assessment Committees during drug development

The FDA released a new draft Drug Safety Guidance for Industry on December 16, 2015. The draft document recommends the use of special Safety Assessment Committees to oversee and report on patient safety data throughout a drug's development program. The intended impact is to improve patient safety through a

December 17th, 2015|
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Strategic Planning for Expert Committees can save 40% in Endpoint Adjudication and Data Monitoring Costs

Philadelphia, PA – ACI Clinical (www.aciclinical.com), an industry leader in independent committee management, offers expert review of clients’ clinical research needs to develop comprehensive, strategic committee solutions across entire drug programs. These solutions leverage opportunities for cost savings and operational efficiencies by implementing committees on a more global scale

October 21st, 2015|

Milestone reduction in CV outcomes for Anti-Diabetes trial

The New England Journal of Medicine today shared landmark results from the EMPA-REG OUTCOME trial. The study revealed a marked reduction in cardiovascular (CV) mortality and morbidity for high CV risk type 2 diabetes patients when taking empagliflozin (a sodium glucose cotransporter 2 inhibitor). Throughout the randomized, double-blind, placebo-controlled trial, all cardiovascular

September 18th, 2015|

ACI supports DMC improvement project with Clinical Trials Transformation Initiative

ACI Clinical representatives participated in a Clinical Trials Transformation Initiative (CTTI) Expert Meeting on July 28-29, 2015, in Silver Spring, MD. The meeting served as part of an ongoing CTTI project to improve the quality and usage of DMCs. The two-day expert meeting brought together diverse clinical trials stakeholders,

August 3rd, 2015|

Navigate increasing Drug Development requirements with support from ACI Clinical

PHILADELPHIA – The recent FDA Safety and Innovation Act (FDASIA) combined with the Pediatric Research Equity Act (PREA) now mandates that prior to Phase III testing in adults, all drug development programs must submit an additional study plan for the pediatric population. To conform to the new mandate, every

June 25th, 2015|

Current Thinking and Rationale for Endpoint Adjudication

ACI Clinical President Dr. Jonathan Seltzer presented and led a panel at a recent Endpoint Adjudication Conference held in Philadelphia, PA, on May 5-6, 2015. The two-day conference gathered representatives from the FDA, industry and academia to learn from one another and share some of the latest tips and

May 18th, 2015|

ACI Clinical Sponsors Endpoint Adjudication Conference in Philadelphia

Representatives from the FDA, industry and academia will share best practices and strategies for endpoint adjudication at an upcoming conference in Philadelphia, PA, on May 5-6, 2015, at Doubletree by Hilton. The two-day conference will include workshops, panels, an adjudication case study, and an interactive think tank. What: Endpoint

April 15th, 2015|

Identify and Engage Medical Experts with Ease

PHILADELPHIA – ACI Clinical announces a new solution for Life Sciences companies facing the growing difficulty surrounding the identification and engagement of independent medical experts. With over a decade of experience building and managing a global network of medical thought leaders, ACI offers a complete solution that simplifies all

March 24th, 2015|
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