Data Migrations Spike; Sentrx Assists Customers in Addressing New Guidance Concerning the Development Safety Update Report (DSUR)

Sentrx, an industry leader in providing outsourced drug safety solutions, comprehensive pharmacovigilance solutions and data management services, weighs in on new DSUR guidance.

Little Falls, NJ, March 10, 2012 --( In an effort to continually improve safety data reporting and protect the well-being of consumers of pharmaceutical products, the U.S. Food and Drug Administration (FDA) often issues new regulations and guidances. In August 2011, the FDA released a new guidance concerning the Development Safety Update Report (DSUR) which regulators are accepting in place of the previously required Investigational Annual Report submitted to the FDA and the EU Annual Safety Report submitted to the EU annually. These reports were required to provide a progress of the investigations over past year, including the status of the investigations, summary of the adverse event profile, investigational plan and revisions to the reference document and protocols. The new guidance requires that DSURs which are an enhanced report over the previous required reports contain not only an evaluation of safety information collected in the past year but also includes a cumulative review of existing safety information. This evaluation allows the sponsors the ability to identify and evaluate potential risks with the drug and make appropriate adjustments to their clinical development program.

According to Michael O’Gorman, CEO of Sentrx, “This guidance increases the need for data migration services. Historically, the need for safety data migrations arose when certain events such as consolidations or mergers took place. In addition, pharmaceutical companies needed to migrate data to a single database platform when the data management from multiple sources such as CROs or EDC systems became unmanageable or ineffective for signaling purposes. Now that the DSUR requires a cumulative review of safety information, it is very important to have all of the safety data in one place. We believe that consolidating all safety data into a single hosted safety database is the best solution because there are no barriers to providing access and if done properly, the safety database can be utilized globally for data entry, safety analysis and reporting. As many people in the industry are aware, electronic migrations alone may not be sufficient and are often very costly. The great thing about Sentrx is that we have a special projects unit designed to easily handle any size data migration project, with full manual data entry capability and quality assurance of case information. For larger data migration projects, we combine electronic and manual processes to ensure the highest degree of data integrity.”

Sentrx’s data migration services can be provided either in Sentrx’s hosted environment or an in-house safety database.

How Data Migration Helps With Development Safety Update Reporting
Providing the FDA and EU with cumulative safety data of an investigational product from clinical trials can be challenging when all the safety data is not housed in a single secure location. Ensuring that this data is in one place will increase accessibility and allow for easier viewing, evaluation and reporting development on the safety profile of the drug. Sentrx’s unique data management solution services combine the technology, processes, and expertise that best meet the needs for each client and their specific projects to identify the required data elements and approach to migrate the data into a single safety source. Sentrx has an experienced staff of professionals including Wade Weinzetl, VP of Safety Systems Technologies, who has over nine years of experience and Doreen Lechner, PhD Executive Vice President Pharmacovigilance Client Services and the head of the Sentrx Adverse Management Unit, an industry veteran with exceptional command of drug safety and all of its related issues including expertise in quality standards, pre-qualification audits, client audits, and regulatory audits.

With Data Migration services carried out by Sentrx a client can expect consistency, flexibility, seamless software implementation with their company’s processes and, above all, quality management for data integrity. All of these important factors in the transitioning of safety data to one secure location.

For additional information on Sentrx – including details regarding data migration or the full range of available pharmacovigilance services – visit

About Sentrx
Sentrx is a leading provider of technology-enabled solutions and services for global drug safety. Its mission is to help pharmaceutical, biotechnology, medical device, and consumer health companies document the safety profile of their products during clinical development and post-approval, enabling them to minimize risks and maximize benefits. Through its multilingual Safety Response Center, Sentrx delivers a unique combination of highly skilled medical experts, exclusive technology, and best practices in drug safety monitoring. To learn more about Sentrx, please visit the company's website at, or call 973-812-7575.

Amanda Ignaut