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 chosen to deliver regulatory consulting services for a Phase III trial that UCB Pharma is conducting in the development of a unique biopharmaceutical product to treat Rheumatoid Arthritis (RA).

UCB is adhering to recent statements issued by the U.S. Food and Drug Administration (FDA) indicating that researchers need to ensure all measurements and outcomes reflect what is actually happening with the patient (October 2011.) Specifically, instruments based upon a clinician’s evaluation of a patient (ClinROs), and measures taken by an observer (ObsROs), like a mother reporting about her child, are subject to the same requirements for reliability and validity as Patient Reported Outcomes (PROs), as delineated in the PRO Guidance (2010).

UCB’s trial protocol includes the Assessment of Joint Tenderness/Pain and Swelling (TSJ/C), a commonly used ClinRO instrument which clinicians use to document tenderness/pain and swelling during physical examination of a patient.  UCB is migrating or moving the TSJ/C from the traditional paper-based administration to an electronic tablet, invivodata’s SITEpro^® Tablet.

Consistent with FDA recommendations, UCB has contracted with invivodata to demonstrate that the use of an electronic tablet will not affect how clinicians interpret and use the TSJ/C instrument. invivodata’s scientists and regulatory experts will conduct cognitive interviews of clinicians to establish that electronic administration of the TSJ/C is equivalent to traditional, paper-and-pencil administration.  

“Since electronic COA (eCOA) data will be the basis of our labeling claims, we needed a partner with not only technological expertise, but one who fully understands the evolving changes in US and European regulations,” said Geoffroy Coteur, Sr Health Outcomes Manager, at UCB.  “We chose to work with invivodata based on their unique, integrated approach to developing, implementing, and justifying effective COA strategies.  We are confident that their scientific and regulatory expertise, as well as their proven experience in conducting international trials makes them the best suited to help us meet our development objectives.”

“We are pleased to have been selected to perform these important pre-trial tasks that ensure UCB can have trust and confidence in this critical data,” said Dr. Jean Paty, invivodata Co-founder, Chief Scientist and Regulatory Officer. “ To our knowledge, this is the first example of a ClinRO instrument going through a regulatory-driven migration process.  We applaud UCB for their pioneering efforts to ensure all of their COA instruments meet the regulatory standard of well defined and reliable instruments.” 

For more information on invivodata’s consulting services and eSolutions for effective COA data capture, visit www.invivodata.com.

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 projects 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 – 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 conference, PROficiency™ 2012: PROs and Beyond, provided biopharmaceutical researchers with current, relevant information on effectively using Clinical Outcome Assessments (COAs) in clinical development with focus on recent trends pertaining to regulators’ increasing emphasis on all patient centered data, including patient-, clinician-, and observer-reported outcomes (PRO, ClinRO, and ObsRO).

Three-time conference attendee Chris Prue, Vice President of Regulatory Affairs at Cerenis Therapeutics commented, “I thought the conference was excellent this year.  invivodata delivered ‘up to the minute’ information on FDA and EMA perspectives and thought processes that are immensely helpful to me and my company as we integrate this knowledge into the strategic planning for our development programs.”

The conference enabled researchers from over 30 biopharmaceutical companies to advance their knowledge on the scientific, regulatory, and technical aspects of COA and electronic COA (eCOA) data collection.  The 2-day conference began with a keynote address from Deborah Collyar, President of Patient Advocates in Clinical Research (PAIR), who demonstrated the benefits of involving patient advocacy and listening to the voice of the patient during clinical development.  Attendees then participated in interactive assemblies and track sessions delivered by international biopharmaceutical researchers and leading experts who shared case studies of effective COA data collection in support of product labeling, reimbursement, and commercialization.  The conference concluded with a mock regulatory panel that enabled attendees to witness what occurs ‘behind the scenes’ of researchers’ planning discussions and interactions with regulatory agencies during COA strategy development.

“We’re extremely pleased with the success of this year’s conference, which comes at a time of important change within the clinical development community,” said Doug Engfer, President and CEO of invivodata.  “With FDA’s recent expansion of its PRO Guidance to all COAs many researchers are eager to determine the most effective path for including patient experience in their clinical development programs.  It’s our hope that attendees came away from the conference with knowledge and practical information that will be used day-to-day in their clinical research.”

Select content from this year’s annual conference will be delivered in a series of 1-day regional conferences invivodata will host throughout the U.S.and Europe beginning September 2012.  For information on dates, locations, and program agenda, please visit http://www.invivodata.com/resource-center/proficiency-educational-series/proficiency-regional-conferences/.

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 – 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 response to regulators’ increasing emphasis on patient centered data, including patient-, clinician-, and observer-reported outcomes (PRO, ClinRO, and ObsRO), invivodata is integrating its consulting division – formerly PRO Consulting™ – into its portfolio of Clinical Outcome Assessment (COA) consulting services.  The new service will be called invivodata Consulting and will both complement and integrate with the eSolutions and regulatory services provided by invivodata.

invivodata Consulting supports researchers as they design, select, implement, and defend to regulators and other key stakeholders all forms of COA data collection in the development of new medical products.  Now that the U.S. FDA has made clear that clinical research must take into account all COAs, including PROs, ClinROs, and ObsROs, invivodata provides clinical researchers a full spectrum of high quality services that ensure all COA data meets the new, more stringent regulatory standards for accuracy and reliability.  Depending on the research team’s specific needs, invivodata can deliver a fully-integrated set of COA services across the product lifecycle, or selected services to meet the team’s objective.

“Our COA consulting services have been widely adopted in the biopharmaceutical and medical device community, as researchers increasingly seek scientific and regulatory expertise in developing, executing, and justifying their COA strategies to regulators and other stakeholders,” said Doug Engfer, President and CEO of invivodata.  “Offering these scientific and regulatory services as a component of our broad COA data capture solutions delivers more value to our clients and allows us to respond to all of their needs.  Now our clients will interact with one organization, regardless of whether their needs center around critical pre-study consulting work, proven eSolutions for COA data capture in clinical trials or, as in many cases, both.” 

To reflect this evolution, invivodata is launching a new corporate Website, where visitors can easily find information on current, global regulations pertaining to COA research, read successful COA data collection strategies and implementation case studies, and determine which invivodata eSolutions and/or consulting services will best help them meet their development, labeling, and commercialization goals.  Website visitors can also view and download recent industry publications on a broad variety of topics pertaining to COA data collection at invivodata’s online COAResourceCenter. Visit www.invivodata.com for more information.

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.

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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, clinician, and observer reported outcomes – in clinical trials.

invivodata reported continued and accelerating growth in 2011, stemming from the addition of over 160 clinical projects – more than double the number claimed during the same time period by the next largest ePRO provider.  invivodata’s experience has grown to over 600 clinical projects in 67 countries and 105 languages. In response to this growth in its business, the company has substantially increased headcount, enabling it to meet the growing needs of its worldwide customer base. These results marked the third consecutive year of accelerating growth in bookings, revenue, and profitability for the company.

While all providers in this space have benefited from broad industry adoption of ePRO solutions over the past several years, invivodata has grown faster than the industry as a whole, being awarded 70% of all competitive projects for which it submitted a proposal.  Compared to data recently made public by its leading competitors, invivodata is now able to confirm that – along with its 95% total revenue growth and 35% service revenue growth – it added more projects and revenue in 2011 than any other ePRO provider.

“After years of investment in our people, products, and processes, 2011 proved to be another record-breaking year for invivodata. Now we want to thank those individuals that have made this achievement possible,” said Doug Engfer, invivodata President and CEO. “We appreciate the continued support from our customers and partners and the excellent work produced by our dedicated employees. Their hard work combined with their scientific, regulatory, and global project implementation expertise continues to be cited by new and existing customers as the reason they choose invivodata. Without them our success would not be possible.”

To thank the customers, partners, and employees that contributed to its success, invivodata is expanding its program of charitable giving, making donations to various foundations which support patient care and research on diseases in which invivodata’s eSolutions and consulting services have been implemented. A list of the organizations invivodata donated to can be found at www.invivodata.com/charitable-donations.

The international biopharmaceutical industry appears to be recognizing invivodata’s leadership position, as evidenced by the growing interest in PROficiency™ 2012, invivodata’s annual educational program.  Over 300 biopharma representatives attended PROficiency meetings in 2011 and registrations for this year’s annual conference – which is taking place April 17-19 in Naples, FL– have already surpassed attendance at the 2011 event by more than 30%.  For more information and to register for PROficiency 2012: PROs and Beyond, visit www.invivodata.com/resource-center/proficiency-educational-series/proficiency-2012.

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.

Dr. Chad Gwaltney

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 pain, are not. These findings support the use of patient-reported outcome instruments as end points when assessing the efficacy of heart failure treatments.

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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.

Dr. Jean Paty

Summary: In this article, invivodata’s Dr. Jean Paty explains how all measurements and outcomes need to reflect what is happening with the patient.

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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.