Scian's Saepro Software Assists Biotechs to Comply With Safety Reporting Under the New IND Safety Reporting Requirements
As of March 28th, 2011, the FDA’s amendments to 21 CFR parts 312 and 320 places the onus on the IND phase drug developers to collect organized data from all sources and notify the FDA and all participating investigators in an IND safety report of potentially serious risks from clinical trials or any other source. The final IND safety reporting rule introduced new requirements that were designed to improve the usability and quality of safety reporting and to strengthen the agency’s ability to review critical safety information and to improve safety monitoring of human drug and biological products as well as harmonize safety reporting with the recommendations made by ICH, CIOMS and EU.
“Organization will be a key to success under the new rule,” said Mark Donaghy, General Manager of SciAn. “The FDA has placed new responsibilities on sponsors to know what adverse effect information has been documented, and to be able to quickly summarize in the sponsor’s reports cumulative information from multiple sources as it becomes available. With 15 calendar days to report after the sponsor’s initial receipt of the information, or 7 calendar days in the case of unexpected, fatal or life-threatening suspected adverse reactions, effective management of information becomes critical.” SciAn’s SAEpro Drug Safety Workbench was designed for IND Phase I, Phase II and Phase III programs and has been used by clients for six years to help organize their information by collating all of the AEs and SAE data across multiple studies into one system for analysis and reporting. SAEpro helps to increase the speed of delivering information and remove the ambiguity from recording SAEs with simple and effective functions that provides all of the references and tools needed to quickly summarize issues, analyze between reported events and complete submissions. SAEpro is customizable to meet individual client business processes and SOPs for the SAE review and approval process, notification and distribution workflow. Status and analysis reports are available in standard format or customizable to meet individual company needs. The beauty of SAEpro is that it can be configured to interface to other systems as required. SciAn offers a full-service SAE program but also has three different SAE service levels that are scalable to meet specific support requirements.
For further information about SciAn’s SAEpro software please visit our website at www.SAE-pro.com or to book a free SAEpro demonstration please call 1-800-915-9315 or email: info@scian.com. About SciAn Established in 1986, SciAn Services, Inc., is a Contract Research Organization (CRO) and has been providing clinical trial services for 25 years and drug safety services of investigational new drugs for 15 years. SciAn is also a software developer and has two products on the market: EDCpro for clinical trial services and SAEpro for drug safety reporting services. SciAn has written numerous knowledge-based articles on clinical trials and drug safety related topics. To date, the company has completed over 605 studies in a wide range of therapeutic areas
For more information, please contact:
Jasna Szwagiel Corporate Communication Email: jszwagiel@scian.com
URL: www.scian.com / www.SAE-pro.com
SciAn Services, Inc. North American Toll Free: 1-800-915-9315 King of Prussia, PA 610-945-1763 Walnut Creek, CA 925-407-2069 Toronto, ON 416-231-8008