Veeva Vault CDMS to manage clinical data for expanded access program for a neurologic disorder treatment
PLEASANTON, Calif.–(BUSINESS WIRE)–#EDC—Veeva Systems (NYSE:VEEV) today announced that Early Access Care Limited has selected Veeva Vault CDMS to provide electronic data capture (EDC), coding, and data cleaning for their upcoming expanded access study.
Early Access Care is a global organization accelerating access to investigational drug products for patients in need. Expanded access is the U.S. FDA process that gives patients access to investigational treatment outside of a clinical trial when other options are not available. This helps patients continue treatment after the completion of a trial. If the FDA has approved an expanded access protocol (EAP), patients can enroll for continued access until the drug is commercially available.
Early Access Care recently initiated a multi-center FDA-approved expanded access protocol for the treatment of a neurologic disorder. The program is expected to enroll 200 patients and provide continued treatment with this promising investigational therapy. For the duration of the program, Early Access Care will collect and monitor data using Veeva Vault CDMS.
“Veeva Vault CDMS is the answer to our data collection needs,” said Anne Cropp, chief scientific officer at Early Access Care. “The startup of this expanded access program with Veeva Vault CDMS was rapid and efficient. The system is high-quality and easily configurable, with advanced data management capabilities that are intuitive.”
Learn more about Vault CDMS at the upcoming Veeva R&D Summit, Sept. 8-10, 2019 in Philadelphia, PA. The event is open to Veeva customers and invited guests. Register and view the agenda at veeva.com/R&DSummit. For more information on Vault CDMS, visit veeva.com/CDMS.
About Early Access Care
Early Access Care helps pharmaceutical companies with integrated solutions customized to their expanded access and post-trial program needs. Early Access Care develops EAP strategies and effectively manages the end to end expanded access process. Their goal is to Make Access More AccessibleTM to patients. EAC offers comprehensive services to manage requests globally, enabling biopharmaceutical company resources to focus on drug development. For more information, visit www.earlyaccesscare.com.
About Veeva Systems
Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 750 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.