MALVERN, Pa. Sept. 18, 2012 — The management of Protocol Violations (PVs) is a consistent area of difficulty for Clinical Data Management (CDM). Often this is due the fact that multiple parties from site investigators, clinical research associates, data managers and others are involved in the process, leading to potential data integrity issues and forcing companies to rely on a cumbersome paper-based approach. Teaming up with customer Human Genome Sciences (HGS), DSG will unveil its new module for PVs at the 2012 Society for Clinical Data Management (SCDM) Annual Conference in Los Angeles Sept. 22-25.
Solving this problem that ensures data integrity and reliability HGS needed a partner to design a PVs system that takes full advantage of the dynamic EDC capabilities embedded in eCaseLink™. The new module, an add-on feature to the EDC software, allows different user groups, such as CRAs or DMs or pharmacy personnel to interact with this module and ensures protection of potentially un-blinding data.
Once again, DSG has partnered with its clients and taken on their challenges creating a more flexible, cost-efficient method to handle PVs. This agile approach has been a hallmark of DSG for more than 20 years, along with its unmatched delivery record for quick database locks leading to dozens of drug and device approvals. All of this is done in tandem with its customers to provide superior technology, service at lower cost.
Since implementing the module in a global study in more than 20 countries and 800 subjects, HGS found:
- A dramatic reduction in use of paper
- PV module ensures protection of potentially un-blinding data
- Reduction in duplicate data
- Accurate real-time custom reports tailored to meet needs of user
- Built in such that all actions and changes are audit-trailed with reporting capabilities.
“The creation of this PV module is a perfect example of a well-established collaboration between a technology provider and sponsor,“ said Michael Goedde, senior director, clinical data management at HGS. “We faced a significant challenge with PVs and were committed to using a more innovative approach than paper, especially in the Phase 3 of our study trial.”
“Helping organizations change their processes to a more efficient and accurate environment has driven successes with clients such as HGS,” said Tony Varano, CEO at DSG. “Most of all, our agility in working with clients to create modules that can be used for all clients means we are taking suggestions and support from our clients and building products and services that are tailored to the market needs”
DSG Inc. supports clinical trial data collection and management with innovative technology solutions, including Electronic Data Capture with specialized Clinical Data Management services, IWRS, Clinical Trial Management Systems and digital on-demand Case Report Form publishing management software. DSG’s products allow user-friendly, accurate and efficient data capture at any investigator site regardless of the technological infrastructure. DSG has successfully supported over 1,000 clinical trials for more than 400 companies at over 25,000 sites in more than 90 countries. Founded in 1992, DSG is a global company headquartered in Malvern, Pa., with additional offices in the U.S., Japan and India. For more information, please visit www.dsg-us.com.