Audit Trails & Transparency: Tracking Changes in Clinical Data
An audit trail in clinical research is a chronological record of all actions performed on clinical trial data, ensuring data...
Better Audits, Faster through Transparency & Efficiency
The Evolution of Clinical Trial Data Collection Clinical trials have come a long way since the days of collecting and...
OpenClinica lauds White House’s commitment to a stronger clinical trial infrastructure
OpenClinica lauds the White House Office of Science and Technology Policy’s (OSTP) commitment to building a stronger clinical trial infrastructure...
From multi cohort Phase I’s to integrated Phase III’s, FDA eyes efficiency
Two guidance documents, released a month apart this summer, suggest that the FDA is taking up a concern that sponsors...
“You’ve Got Findings!”: To the 90’s and Back with GCP E6(R2)
Imagine a time when phones boasted no smarts. When technophiles worshipped noisy gadgets called modems. When The Human Genome Project...
What is GDPR (And Why Should I Care)?
Some laws govern the use of crosswalks; others, how to clean up after our pet in public spaces. Then there’s...
Free Webinar, Aug 27: Successful Part 11 Compliance in a Universe of Electronic Data
Regulatory compliance may not always be the life of the party, but understanding its basics and being prepared for some...
Pipes, Hats … and OpenClinica: Digesting HL7 in OpenClinica
If you’re an OpenClinica administrator somewhere, the chances are good somebody has asked you: “Can OpenClinica handle HL7 messaging?”“No, it...
CDASH: A new way to standardize data elements
Many people who work with EDC systems have heard of or been impacted by CDISC, Clinical Data Interchange Standards Consortium. ...