CONSHOHOCKEN, Pa., April 13, 2011 /PRNewswire/ -- At the World Drug Safety Congress in Boston, MA, ePharmaSolutions announced a major release of its global safety letter distribution system to support the most recent national and local regulations while offering sponsors a more simplified workflow with advanced distribution and tracking capabilities.
The distribution and tracking of safety letters has been an expensive and time consuming process for global biopharmaceutical companies who are required to remain in strict compliance with national and local regulations while reducing overall trial cost. As regulatory bodies increase their requirements for timely distribution of safety information during and after clinical trials are conducted, pharmaceutical companies are pressured to comply and need cost effective solutions to support the global enterprise.
"Tracking the distribution of safety letters has typically been a manual process that is delivered by overnight courier, fax or email and requires significant logistical preparation to ensure the right sites receive the right safety letters at the right time," stated Dave Espenshade, ePharmaSolutions' Senior Vice President of Sales. "However most of these methods cannot ensure the right users actually received and read the notification, and none of them support all of the current regulations at the national and local level," added Espenshade.
ePharmaSolutions' latest release includes a full integration with the leading CTMS vendors in real time, automatically generating distribution lists using sophisticated algorithms that operate at region, country, compound, study, site and EC/IRB levels, and eliminating any room for error. In addition, the system integrates with leading drug safety systems and distributes notifications via email, fax or courier providing a central repository for reporting – regardless of the distribution method. The Safety Letter Distribution system supports all types of safety letters including blinded, unblinded and open label distributions, IBs, Addendums and Core Data Sheets, 7 and 15 day SUSARs, ASRs, SSRs, and DSURs.
"This release provides our clients with the most comprehensive and compliant solution currently available and can be rapidly deployed at the enterprise or project/compound level using our fully validated cloud based model," added Lance Converse, ePharmaSolutions Founder and CEO.
Philip Ditoro, Esq. of ePharmaSolutions will be presenting a demonstration of the Safety Letter Distribution and Tracking system along with lessons learned Q&A regarding global deployment of this enterprise solution at the World Drug Safety Congress in Boston, MA on April 13th, 2011.
ePharmaSolutions is a leading provider of technology-based clinical services that helps improve the way sites are selected, trained, activated and managed to exceed enrollment goals. ePharmaSolutions won the 2009 Bio-IT World Award for best clinical trial technology and has activated and trained more than 220,000 clinical researchers in 107 countries for the top 20 pharmaceutical companies in the world. ePharmaSolutions is headquartered in Philadelphia with offices in London. For more information visit www.epharmasolutions.com or call Lance Converse at 610-832-9915. Follow us on LinkedIn and Facebook.