Safety Reporting: It Can Enter the 21st Century – If We Let It

In September 2017, Dr. Jonathan Seltzer, President of ACI Clinical, and Dr. Amit Bhattacharyya, Vice President of Biometrics,  co-wrote a publication on the evolution of safety reporting and the possible paths the FDA Draft Guidance on Safety Reporting can take moving forward. Click the image below to access the

October 2nd, 2017|

ACI Clinical Sponsoring CEN ISBS Vienna and ExL’s DMC Optimization Summit

ACI Clinical is proud to be sponsoring both CEN ISBS in Vienna, Austria and ExL’s DMC Optimization Summit in Philadelphia, Pennsylvania. ACI will be attending and presenting at the Joint Conference on Biometrics and Biopharmaceutical Statistics (CEN ISBS Vienna 2017) in Vienna, Austria on August 28 – September 1,

August 22nd, 2017|

ACI Attending Upcoming ASCO and DIA Conferences

ACI Clinical will be attending both the upcoming ASCO and DIA conferences in Chicago next month. The 2017 ASCO  Annual Meeting will be held from June 2 – 6 in Chicago, IL. ACI will be at the DIA Annual Meeting from June 19-20, also in Chicago, IL. If you'd

May 8th, 2017|

ACI Clinical Hits New Milestone: 50,000 Adjudicated Endpoints

Philadelphia- ACI Clinical has surpassed a new milestone of 50,000 adjudicated endpoints during the first quarter of 2017. The specialty adjudication company is pioneering adjudication practices beyond the traditional large cardiovascular outcome trials into a wide breadth of medical specialties with emerging needs for safety and efficacy endpoint evaluation.

April 11th, 2017|

ACI Clinical Expands Leadership Team to Support Growth

Philadelphia –  ACI Clinical, the leading independent specialty provider of Endpoint Adjudication and Data Monitoring Committees to the clinical trial industry, is proud to announce the addition of two new executives, Andrew MacKnight and Amit Bhattacharyya. Both are seasoned industry professionals with successful track records managing organizational growth.   "Timing

November 29th, 2016|

ACI Sponsoring Adjudication Conference in Philadelphia, PA

ACI Clinical is pleased to be a sponsor at the upcoming 2016 Endpoint Adjudication Forum in Philadelphia on October 19-20, 2016. Highlights of the conference include a presentation and discussion on industry best practice, performance standards by ACI’s EAC Lead, Shaena Kaufman, on Wednesday, October 19 at 2:45 p.m.

October 18th, 2016|

ACI Clinical and Pinnacle 21 Announce Clinical Data Standardization Services

PLYMOUTH MEETING, Pa. -- Pinnacle 21, the leading provider of clinical data standards software and subject matter expertise to the life sciences industry, today announced the availability of a comprehensive set of expert clinical data lifecycle services. Pinnacle 21, known for their Pinnacle 21 Enterprise software used by FDA,

July 1st, 2016|

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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