DiaryPRO helps Insys Therapeutics with data efficacy

Wednesday, February 15, 2012 03:28 PM

DiaryPRO, invivodata’s field-based electronic COA solution, captured the primary efficacy data in the pivotal studies that led to Insys Therapeutics’ successful New Drug Application (NDA) for Subsys (fentanyl sublingual spray).

Since Insys needed to demonstrate the onset of pain relief following medication, it chose an electronic diary (eDiary) to capture this critical patient reported outcome (PRO) data.  Insys selected invivodata’s DiaryPRO for its phase III clinical trial based on its effectiveness at capturing real-time, patient-centered data and user-friendly features that enable patients to easily record data, even during temporary, and sometimes severe, pain flares. 

“We had a very good experience working with invivodata and are thrilled with the results they delivered in support of the Subsys development program,” said Neha Parikh, senior director of clinical operations at Insys. “We feel strongly that without invivodata’s expertise in designing and implementing effective COA data capture solutions, we could not have captured the critical, time-sensitive data we needed to demonstrate the full therapeutic benefit of Subsys.”

Share:          
CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

Already a subscriber?
Log in to your digital subscription.

Purchase the July issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

Already a subscriber?
Log in to your digital subscription.

Purchase the June issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs