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

April 13

Quintiles-Quest Diagnostics joint venture latest in CRO-central lab deals, more could be on horizon

Biotech companies raise record amount of capital in Q1

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs