Driving the ePRO Industry for 25 Years

For over two decades, invivodata scientists have defined the electronic Patient Reported Outcomes (ePRO) industry by continually developing and applying proven scientific principles and innovative methods to collect the most valid and reliable PRO data possible.

• 1987 invivodata co-founder Dr. Saul Shiffman creates the first handheld electronic patient diary to capture real-world, real-time PRO data in a trial of addictive behaviors.

• 1994 Dr. Shiffman’s work in Ecological Momentary Assessment (EMA), the conceptual basis for diary research, is published as a Concept Paper in the Annals of Behavioral Medicine.

• 1997 Dr. Shiffman and fellow invivodata co-founders Dr. Jean Paty and Doug Engfer successfully port their ePRO system to the Palm™ Pilot.

• 2001 invivodata introduces the first wireless ePRO solution.

• 2002 invivodata is first to document significant increases in patient compliance with electronic diaries in an industry study, “Patient Non-compliance with Paper Diaries,” published in the British Medical Journal.

• 2003 invivodata’s ePRO system captures primary endpoint data for Allergan’s critical Phase III trials of ACULAR LS™, the industry’s first NDA supported by electronically collected PRO data to achieve FDA approval (reference on file, NDA #21-528).

• 2004 invivodata’s ePRO system is first to prove PRO data captured electronically can increase trial sensitivity by reducing error variance, resulting in dramatically smaller, faster, less-expensive studies (“Proving the eDiary Dividend,” Applied Clinical Trials).

• 2005 invivodata launches PRO Consulting, a scientific and regulatory consulting division designed to help clinical research teams effectively develop, execute, and document patient reported outcome (PRO) strategies to support their clinical research objectives.

• 2006 invivodata introduces and implements first integration of data collected from blood glucose meters and electronic patient diaries in clinical trial.

• 2007 invivodata develops and implements first standard, configurable CDISC ODM based integration between ePRO and EDC system (Medidata RAVE^®) to decrease deployment time and improve investigative site efficiency.

• 2008 invivodata launches their annual spring ePRO industry conference.

• 2008 invivodata launches SitePRO® Tablet to the market – a large-screen in-clinic ePRO data collection device.

• 2008 invivodata announces the 7th NDA approval of a drug that used their system. The study was the first to capture primary endpoint data using both a daily eDiary (DiaryPRO) and an in-clinic data capture (SitePRO).

• 2010  Quintiles selects invivodata as their primary partner for ePRO Solutions.

• 2011 invivodata releases DiaryPRO Web – a web-based electronic diary ideal for late-phase studies with a large number of patients.

• 2012 invivodata announces the expansion of PROficiency, their annual spring industry conference. PROficiency 2012 – PROs and Beyond will address all outcome assessments including ClinROs and ObsROs.

By working with invivodata, clinical trial sponsors gain access to the unique expertise of a group of pioneering individuals who have dedicated their professional lives to researching and developing methods to derive the most measure-sensitive, scientifically valid data from patients in clinical trial research. Click here to learn more about using invivodata’s ePRO solutions in your next clinical trial.