Data Captured by invivodata’s DiaryPRO Contributes to Successful NDA for INSYS Therapeutics

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invivodata Delivers Time-sensitive Data that Demonstrates Full Therapeutic Benefit of SUBSYS

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“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.

invivodata inc.®, the industry leader in reliable electronic solutions and strategic consulting services for successful Clinical Outcome Assessment (COA) data collection in global clinical research, today announced that DiaryPRO®, its 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. INSYS received US Food and Drug Administration (FDA) approval to market SUBSYS for the treatment of breakthrough cancer pain medication last month.

Breakthrough cancer pain is characterized by sudden, often unpredictable, episodes of intense pain which can peak in severity at three to five minutes despite background pain medication. Since INSYS needed to demonstrate the onset of pain relief following medication, they chose an electronic diary (eDiary) to capture this critical patient reported outcome (PRO) data. INSYS selected invivodata’s DiaryPRO for their Phase III clinical trial based on its effectiveness at capturing real-time, patient-centered data and its easy-to-use features which 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.”

During INSYS’ pivotal trial, over 100 study participants used DiaryPRO multiple times each day to record responses to questions about the frequency and intensity of pain, usage of study- and supplemental-pain medication, and onset of pain relief following medication. In order to capture onset of pain relief, invivodata designed an eDiary solution that prompted patients to complete an assessment of their pain at several post-dose intervals.

“We are pleased to have worked with INSYS on the SUBSYS development program and to have contributed to their success at bringing relief to those suffering from breakthrough cancer pain,” said Dr. Wolfgang Summa, invivodata’s Vice President of Worldwide Operations. “We applaud the INSYS clinical team for their commitment to developing products that deliver much-needed improvements in supportive care for cancer patients.”

For more information on DiaryPRO and invivodata’s other COA data collection & consulting services (including PROs, ClinROs, and ObsROs), please visit

About invivodata
invivodata is the only fully-integrated Clinical Outcomes Assessments (COA) company delivering regulatory-proven strategic consulting and practical electronic solutions to biopharmaceutical companies who depend upon patient-centered research. From reliable and scientifically sound consulting that helps research teams effectively develop, execute, and document COA strategies to electronically collecting COA data in global clinical development programs, invivodata helps its customers strategically use patient-, clinician-, and observer-reported outcomes data (PROs, ClinROs & ObsROs) to support labeling claims, enhance reimbursement strategies, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies. invivodata’s electronic solutions and strategic consulting services have been used in over 600 clinical programs and are built upon the industry-leading ePRO system in delivering primary efficacy data for global drug approvals. invivodata inc. is a privately held company with global headquarters in Pittsburgh, PA., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, CA., USA. For more information, visit

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Christine Tobin
invivodata (SBE)
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