Drug Safety Alliance Announces Pharmacovigilance Upgrades
Information technology improvements support implementation of enhanced adverse event reporting software.
Information Technology Improvements Support Implementation of Enhanced Adverse Event Reporting Software
(Research Triangle Park, N.C.) - October 30, 2008 -- Drug Safety Alliance (DSA), a global leader in pharmaceutical safety and pharmacovigilance, today announced major hardware and software upgrades to support the implementation of the new Empirica (TM) Trace adverse event reporting software. The announcement was made as DSA Chief Information Officer Doug Hill presented a case study on the upgrade at the Seventh Annual International Users Conference in San Francisco sponsored by Phase Forward, developers of the software.
Drug Safety Alliance is one of the first companies utilizing Empirica (TM) Trace, which allows pharmaceutical drug developers and other DSA
clients to collect, code, analyze, and report adverse events during clinical trials and post-marketing to meet regulatory reporting requirements in the United States and overseas. The new software replaces Clintrace (TM), a previous version of the software utilized by DSA.
"This upgrade to support Empirica (TM) Trace will add convenience, security, and uptime while enabling us to improve efficiency," said Hill, adding clients will notice improvements at the user level such as an improved electronic submissions module.
According to Hill, DSA started working with Phase Forward in November of 2007 on issues such as moving to windows authentication and
performing necessary hardware changes, having performed risk and gap analysis on the software in April of this year.
"I'm proud of the work our team has done to take this technology to the next level," said Cathy Stokes, CEO of Drug Safety Alliance.
In addition to employing secure, state-of-the-art information technology infrastructure to support database mining, collection and reporting software like Empirica (TM) Trace, DSA's information technology department provides data consolidation services and offers secure database hosting options, acting as a virtual IT department for clients. The IT services offered by DSA complement the company's well-established pharmacovigilance practices.
About Drug Safety Alliance
Founded in 2000, Drug Safety Alliance (DSA) provides pharmacovigilance expertise to large and small pharmaceutical and biotechnology companies to help them develop safe drugs and improve patient safety. DSA's mission is to partner with clients to mitigate their drug safety risks and to maximize product longevity and value. Driven by the highest ethical standards, DSA is uniquely focused to provide high-quality pre- and post-market drug safety services including domestic and international regulatory compliance, safety database support and hosting options, risk management and adverse event case management. DSA is headquartered in the Research Triangle Park region of North Carolina with strategic partnerships worldwide. For more information please visit www.DrugSafetyAlliance.com.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
