Pilgrim Software has beefed up its regulatory reporting platform with the MedDRA adapter for adverse event reporting; the adapter integrates with the company's Complaints Management solution. MedDRA allows Complaints Management users to access its codes to update MedWatch adverse event reports.
Regulatory agencies worldwide are attempting to boost efficiency, the company says in a release. As a result, regulations are changing even while the number of electronic submissions increase. That's also the conclusion of regulatory submission experts in our recent webinar, "The Moving Target of Global Clinical Data Disclosure."
The webinar included expert Patricia Teden, principal at Teden Consulting LLC, who says the most effective way to stay abreast of changes is to participate in the DIA special interest area community (SIAC) for clinical trial disclosure, currently a sub-group of the Clinical QA SIAC.
In addition, a special working group focuses on the registries of regulatory bodies outside the U.S. The group organizes teleconferences with the managers of these registries so they can present information about their use. Teden chairs this ex-U.S. registry working group.
The SIAC also sponsors an annual workshop specific to clinical trial disclosure, she says.
- here's the Pilgrim release