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 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 www.invivodata.com/solutions.

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 ScottsValley, CA., USA.  For more information, visit www.invivodata.com.

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 recognized by the Carnegie Science Center as an honorable mention in the Entrepreneur Category of its 2012 Carnegie Science Awards.

“Carnegie Science Awards recognize and promote outstanding science and technology achievements in western Pennsylvania,” said Ann Metzger, Co-Director of Carnegie Science Center. “We are pleased to add Dr. Shiffman to a distinguished list of 300 individuals and organizations that have been honored since 1997 for improving lives through their commitment and contributions in science and technology.”

Dr. Shiffman is being recognized for his ground-breaking research in the scientific methods and processes that drive patient behavior to produce valid and reliable data and for his development of the first handheld computer solution for collecting patient data during clinical research, which are the foundation of today’s electronic Patient Reported Outcomes (ePRO) industry.

”Working with Saul and watching his concepts for real-time, real-world data collection through ePRO become so widely adopted has been exhilarating,” said Doug Engfer, invivodata President and CEO. “We founded invivodata to further develop the commercial applications of this technology and are extremely gratified by the positive effect it continues to have on the clinical research industry.”

“I am proud to have been recognized by this award. Helping develop PRO science in clinical trials has been a rewarding endeavor, and having the work recognized in this manner is both gratifying and humbling. This honor also reinforces our belief in the importance of keeping clinical research focused on the patient, which is our top priority,” said Dr. Shiffman.

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 www.invivodata.com.

PITTSBURGH, PA – Jan. 17, 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, has provided updated information on PROficiency™ 2012:  PROs and Beyond, its 5^th annual conference on the collection of patient perspective in clinical research.  The conference is being held April 17-19, 2012 in Naples, FL.  Updated conference information, including a complete program agenda and expanded list of international speakers can be found at http://www.invivodata.com/proficiency-2012/proficiency-2012-agenda.

By attending PROficiency 2012, clinical researchers will have access to current, critical information on the regulations and practical considerations of selecting, implementing, and justifying all COAs to ensure they are fit for purpose and appropriate for their context of use.  With a combination of general assemblies and sessions following tracks pertaining to the use of COAs in both Phase 2/3 and late stage research, attendees can customize the conference to suit their needs and specific interests.

“We’ve designed the conference agenda to address the many questions clinical researchers have about recent regulatory changes pertaining to selecting, evaluating, and providing evidence to support endpoints for their clinical development programs,” said Dr.Jean Paty, invivodata Co-founder and Chief Scientist and Regulatory Advisor. “We are thrilled to have these discussions led by a faculty comprised of knowledgeable, international biopharmaceutical developers and researchers with specific experience and insight to the Food and Drug Administration (FDA) and European Medicines Agency (EMA).”

Joining scientists from invivodata and its regulatory consulting division, PRO Consulting^®,   the faculty for PROficiency is comprised of international biopharmaceutical and industry experts, including:

-Olivier Chassany, MD, PhD, Medical Head of the Department of Clinical Research and Development, Assistance Publique – Hôpitaux de Paris

-John H. Powers III, MD FACP FIDSA, Associate Clinical Professor of Medicine at the George Washington University School of Medicine and former Lead Medical Officer for Antimicrobial Drug Development and Resistance Initiatives in the Office of Antimicrobial Products, Center for Drug Evaluation and Research, at the US Food and Drug Administration

-Maria Diviney, Principal Data Manager, Global Data Science, Astellas Pharma Europe B.V.

-Michael Hufford, Ph.D., Chief Operating Officer, NeuroCog Trials

-Sean Stanton, Co-Founder & Owner, Compass Research, LLC

“Our objective is for attendees to walk away from the conference with knowledge of the scientific and regulatory considerations of capturing patient perspective in clinical development,” saidBob Young, invivodata Chief Operating Officer.  “We are confident that the practical topics being presented will provide attendees with valuable information that can be used day-to-day in their clinical research, whether their key stakeholder is a regulatory body or a reimbursement organization.”

invivodata is offering 30% off registration fees for attendees who register before February 13, 2012.  For additional information and to register for PROficiency 2012, please visit http://www.invivodata.com/proficiency-2012.

About invivodata

invivodata is the only fully-integrated Clinical Outcome Assessments (COA) organization 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 data 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 www.invivodata.com.

PROficiency™ 2012 – PROs and Beyond, invivodata/PRO Consulting’s 5th annual conference, will be held April 17-19, 2012 at the Naples Grande Beach Resort in Naples, Florida.

This premiere conference will address the many questions clinical researchers have about recent regulatory changes pertaining to selecting, evaluating, and providing evidence to support endpoints for their clinical development programs.

In October 2011, FDA conducted a public workshop to discuss measurement principles for Outcome Assessments (OAs) used in clinical trials for new drugs, including patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. By attending PROficiency 2012, clinical researchers will have access to current, critical information on the regulations and practical considerations of selecting, implementing, and defending all OAs to ensure they are fit for purpose and appropriate for their context of use.  There’s never been a better time to attend!

Conference Highlights

PROficiency 2012 features international regulatory experts, biopharma professionals and industry experts presenting case studies and strategic and tactical information on the effective and successful use of OAs in worldwide clinical development programs.  Attendees will network and learn from leading industry experts as they participate in general assemblies and track sessions covering the role of OAs throughout all stages of clinical development:

- Early Development

- Pivotal Studies

- Late Stage Research

Attendees will come away from the conference with knowledge of the scientific and regulatory considerations of capturing patient perspective in clinical development – practical input that can be used day-to-day in their clinical research.  Don’t miss out on this must-attend event!

Register by February 1, 2012 and save 30% off the $395 registration fee.

Presenters:
Dr. Jean Paty, Founder and Chief Regulatory and Scientific Advisor, invivodata, inc.
Frank J. Carillo, President and Managing Director, ECG, Inc.

Description:
Comparative effectiveness research is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. Using Patient Reported Outcomes (PROs) to support comparative effectiveness trials is not only logical, but proves to be a valuable tool in helping researchers truly understand the effect of a medical product in the real world.

In this webinar, Dr. Jean Paty and Frank Carillo demonstrate how sponsors can leverage PROs in comparative effectiveness trials to determine a products’ therapeutic potential, define its competitive positioning, and optimize their payor reimbursement strategies.

Register Now

Presented by:

- Laurie Burke, MPH,RPh Director for Study Endpoints and Labeling, Office of New Drugs, CDER, FDA
- Ethan Basch, M.D., M.Sc., Associate Attending Physician, Department of Medicine Associate Outcomes Research Scientist, Department of Epidemiology and Biostatistics, Health Outcomes Memorial Sloan-Kettering Cancer Center
- Jennifer Petrillo, PhD, PRO Expert, Novartis Pharmaceuticals

Moderated by:
- Chad Gwaltney, PhD, Senior Scientist PRO Consulting

Description:
Comparing the safety and efficacy of new medical products to existing products can yield important information for all stakeholders in the healthcare industry. Patient-reported outcomes (PROs) may be used to assess the relative safety and tolerability of active treatments in comparative studies. This presentation, delivered through the Drug Information Association (DIA) will outline methodological and regulatory considerations when using PROs in this manner and describe applied examples.

For more information and to register, click here.