|By PR Newswire||
|August 21, 2014 09:17 AM EDT||
PHILADELPHIA, Aug. 21, 2014 /PRNewswire/ -- ACI Clinical (www.aciclinical.com) announces a new, standards-based platform for independent Data Monitoring Committees.
Using this solution, trial sponsors can save up to 30 percent over industry standard costs and receive the same expertise that has made ACI an industry leader in committee services.
Leveraging a decade of DMC experience (initial design, member recruitment and contracting, charter development, statistical programming and meeting facilitation), ACI analyzed DMC member data request trends to create a thoughtful and automated design of standard statistical output, presented in a clinically meaningful format. The simplified presentation radically eases the data review process and manual effort behind the scenes, allowing DMC members to focus their expertise where needed most. This deep understanding of Data Monitoring Committees has allowed ACI to offer new efficiencies while maintaining regulatory-grade quality and features such as double programming.
"The process is much more streamlined than DMCs in other studies I work on – very efficient," said one committee member. Survey results repeatedly reveal positive physician experiences when working with ACI's smarter committees. A glimpse of ACI's new DMC process was provided to CDISC members in Europe early this year, in an effort to demonstrate how standardized statistical output may be a highly useful training tool for DMC members.
Industry pricing for DMCs varies based on factors including study size, duration and volume of analysis datasets, tables, figures and listings. A recent article published in Applied Clinical Trials presented a strong financial argument illustrating the cost savings sponsors can realize by fully outsourcing their DMCs. ACI's new model is priced at approximately 30 percent below the fully outsourced industry standard. This can mean significant savings for trial sponsors.
About Data Monitoring Committees
Data Monitoring Committees, also known as Data and Safety Monitoring Boards (DSMB), originated in the 1960s as a way to centrally review and monitor patient safety during an ongoing clinical program. The FDA issued a guidance on the proper role of DMCs in 2009, and according to www.clinicaltrials.gov, DMCs are now implemented in approximately 33 percent of trials.
About ACI Clinical
ACI Clinical is a specialty group in clinical research that manages Endpoint Adjudication Committees and Data Monitoring Committees, with related Data and Advisory services. The company has worked across all therapeutic areas and phases of development since its inception in 2001. ACI Clinical has been a CDISC Registered Solutions Provider since 2004.
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