eCTD Readiness
Forward-Looking Regulatory Solutions
There is growing interest in software to generate the electronic common technical document (eCTD). more...
February 8, 2012Regulatory
When Speed Means Slow
Rozwell on Data Standards (Podcast #1)
Gartner distinguished analyst Carol Rozwell talks about drug safety, contract research organizations, data mining and other topics related to CDISC standards. more...
Searching For Sticky Notes
Auditing Technology At Trial Sites
What one auditor of technology at clinical sites looks for. more...
Clinical Content Management
FCG Partners with Microsoft
Since most people in the industry use Office to create clinical trial documents, Microsoft and FCG say it’s high time there is a secure environment for managing it in a regulated industry. The appeal of MOSS. more...
Low Interest So Far
Microdosing Update From FDA
Yes, microdosing is part of the FDA’s Critical Path Initiative. But no, sponsors don’t seem to be interested in extremely low-dose trials yet. Why? The FDA’s David Jacobson-Kram offers some thoughts. more...
Bio-Optronics, Trialstat, Woodcock in NYT
News Briefs
News for June 4th. more...
Regulatory Systems
Mission3 Manages eCTDs, Projects
The rapidly growing company combines document and project management. “We’re looking at binding those two systems together in an open, web services, modern architecture way,” says founder Dirk Karsten Beth. more...
Marketing Coup
CDISC Certifies ClinPhone & XClinical
The data standards organization has embarked on a more extensive program to give rigor to technology suppliers who claim compliance with CDISC standards. There is no comparable program for sponsors of clinical trials yet. more...
Sand In The Gears
The Clinical Data Life Cycle
With the acquisition of Ninaza, a troubled electronic data capture firm, Octagon Research is plunging into a competitive field. more...
Welcome Death To PDFs?
FDA Explores ODM-Based CRF Data
The FDA has announced an intriguing pilot project to explore moving away from PDF-based case report forms. It’s not too early to think about whether your own SOPs and technology infrastructure can readily support the CDISC ODM standard. more...
Toward One FDA
At DIA, FDA Stresses Electronic Data
FDA comments on the eCTD and data standards. more...
Slashing FDA Department?
FDA Women’s Office Faces Cuts
In the middle of the fiscal year, the FDA is proposing an immediate $1.2 million cut to its Office of Women’s Health, for which Congress had already set aside $4 million. Why? Some speculate that it’s payback for the emergency-contraceptives controversy. more...
Demo: Regulation Management System
ViewPoint From Octagon
A tool to create, manage and view both documents and processes in the regulatory environment. more...
Combining Content, Submissions
Qumas Debuts Compliance Suite
A new tool for regulatory submissions and everything that touches them. more...
Signable PDFs
Adobe Wins SAFE Certification
Adobe wins more traction for the PDF format in pharma. more...
The Coming Shift
Octagon’s Advice on eCTDs
In 2008, electronic submissions to FDA will have to be in the eCTD format. Says Octagon Research’s Nancy Smerkanich: “Companies need to prepare. It’s not something you turn a switch on and do overnight.” more...
