The Pulse – Volume 5, Issue 2, Spring 2012
Developing & Defending Effective COA Endpoint Strategies: An Interview with Dr. Chad Gwaltney The U.S. FDA has drafted Guidance and issued recent statements related to the importance of Clinical Outcome Assessment (COA) data – including Patient- Clinician- and Observer-Reported Outcomes (PRO, ClinRO, and ObsRO) – in demonstrating the treatment benefit of new medical products. In.. read more →
invivodata Performing Novel ClinRO Migration Services for UCB Pharma
invivodata conducting first cognitive interviews of a ClinRO instrument to ensure eCOA data is well defined and reliable PITTSBURGH, PA – May 8, 2012–– 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 it has been.. read more →
invivodata Concludes Successful Annual Conference
PROficiency™ 2012 Delivers Current, Practical Information on Patient Centered Data in Clinical Research PITTSBURGH, PA – Apr. 23, 2012–– invivodata inc.®, the industry leader in reliable electronic solutions and strategic consulting services for successful patient-centered data collection in global clinical trials today announced the successful completion of its fifth annual conference in Naples, FL. The.. read more →
invivodata Changes Organizational Structure to Meet Evolving Customer Needs
COA Consulting Services to be Delivered through invivodata Consulting PITTSBURGH, PA – Apr. 11, 2012–– invivodata inc.®, the industry leader in reliable electronic solutions and strategic consulting services for successful patient-centered data collection in global clinical trials today announced organizational changes which will better enable it to serve its biopharmaceutical and medical device clients. In.. read more →
“Accelerated Approval Could Spur Development of Patient Reported Outcomes Tools”, Sutter, S. The Pink Sheet, Vol. 74 No. 13, Mar. 26, 2012
Summary: This Pink Sheet article reviews a subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement. View.. read more →
Continued Strong Growth in 2011 Propels invivodata into the Lead as Top ePRO Provider
invivodata Makes Charitable Donations to Show Appreciation to Customers, Partners, & Employees PITTSBURGH, PA – Mar. 22, 2012–– invivodata, inc.® today announced growth figures from 2011 that show invivodata has solidified its position as the industry leader in electronic solutions and strategic consulting services for collecting Clinical Outcome Assessments (COA) data – which include patient,.. read more →
“Hearing the voice of the heart failure patient: key experiences identified in qualitative interviews.” Gwaltney, C., Slagle, A., Martin, M., Ariely, R., Brede, Y., British Journal of Cardiology, Mar. 2012
Summary: This article reviews a study in which qualitative interviews were conducted with chronic heart failure patients in order to identify key experiences that may be targeted as end points in future heart failure trials. It concludes that although some experiences are already widely captured in clinical and patient-reported heart failure assessments, others, such as.. read more →
Data Captured by invivodata’s DIARYpro Contributes to Successful NDA for INSYS Therapeutics
invivodata Delivers Time-sensitive Data that Demonstrates Full Therapeutic Benefit of SUBSYS PITTSBURGH, PA – Feb. 14, 2012–– 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.. read more →
invivodata Co-Founder Dr. Saul Shiffman Recognized by Carnegie Science Awards
Shiffman Recognized for Groundbreaking Research in Patient Data Collection PITTSBURGH, PA – Feb. 3, 2012–– 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 it’s co-founder and chief science officer, Dr. Saul Shiffman, has been.. read more →
“Give the Patient a Clear Voice”, Paty, J., Applied Clinical Trials, Feb. 2012
Summary: In this article, invivodata’s Dr. Jean Paty explains how all measurements and outcomes need to reflect what is happening with the patient. View Publication read more →