TORONTO, ON – April 4th, 2011 – SciAn Services Inc., a Contract Research Organization (CRO) providing clinical research services as well as electronic data capture (EDC) and serious advent (SAE) software to pharmaceutical and biotech companies confirmed today the Company’s attendance at the Bio 2011 International.
“Bio 2011 International convention is a biotechnology conference and exhibition for biotechnology, life sciences and industry professionals from around the world,” says Mark Donaghy, Vice President Finance & General Manager. “Many of our clients and friends attend to learn of major trends affecting the biotech industry. As SciAn is as dedicated to helping the industry develop new best practices in efficiency and quality as it is to providing high service standards, we value the opportunity to learn and demonstrate what we have learned.”
This year SciAn launched its serious adverse event (SAE) reporting software - “SAEpro” v.4 that assists biotech companies to comply with the safety reporting requirements of 21 CFR Parts 312 & 320 set forth by the FDA.
Effective March 28th, 2011, the FDA’s amendments to 21 CFR parts 312 and 320 added new requirements to improve the usability and quality of safety reporting and to strengthen the agency’s ability to review critical safety information. The amendments place the onus on the IND phase drug developers to aggregate organized safety data from all sources and analyze it effectively as well as notify the FDA and all participating investigators in an IND safety report of potentially serious risks from clinical trials or any other source within a certain time limit depending on the type of adverse event reported.
Clients have used SciAn’s SAEpro Drug Safety Workbench for IND Phase I, Phase II and Phase III for six years to help organize their information by collating all of the AEs and SAE data across multiple studies and information databases into one system for analysis and reporting. SAEpro helps to increase the speed of delivering information and to remove the ambiguity from recording SAEs. Simple and effective functions provide all of the references and tools needed to quickly summarize issues, and to 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.
SciAn will be providing demos of its proprietary clinical research softwares: SAEpro for drug safety reporting services as well as edcpro for the management of data electronically in clinical research. The demo dates and times will be announced once finalized.
For further information about SciAn’s SAEpro or edcpro softwares please visit our websites at www.sae-pro.com and www.edcpro.com or to book a free SAEpro or edcpro 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 or www.thebiotechcro.com
SciAn Services, Inc.
MASSACHUTSETTS
P: 508-620-4533
CALIFORNIA
P: 925-407-2069
PENNSYLVANIA
P: 610-945-1763
TORONTO
P: 416-231-8008
