Medidata Solutions

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Medidata Solutions
Type Public
Traded as NASDAQMDSO
Industry Clinical development technology
Computer software
Software as a service
Founded New York, USA (1999)
Founder(s) Glen de Vries
Edward Ikeguchi, MD
Tarek Sherif
Headquarters 350 Hudson Street, New York, NY, United States
Area served Worldwide
Key people Tarek Sherif (CEO)
Tarek Sherif (Chairman)
Glen de Vries (President)
Products Medidata Insights
Medidata Designer
Medidata Grants Manager
Medidata CRO Contractor
Medidata CTMS
Medidata Balance
Medidata Rave
Medidata Coder
iMedidata
Revenue Increase $218.3 million (2012)[1]
Employees 900+ (December 31, 2012)
Website mdsol.com

Medidata Solutions is an American-based multinational computer technology corporation that specializes in developing and marketing cloud-based solutions to address functions throughout the clinical development process. The Medidata platform is designed to improve study design, protocol development, trial planning and management, site collaboration and management, randomization and trial supply management, monitoring, safety event capture, clinical data capture (EDC) and management, advanced reporting and business analytics. Headquartered in New York, New York, United States, Medidata employs 900+ people worldwide as of 31 December 2012. Medidata Solutions has a total of nine offices with locations in the United States, the U.K., Japan, and China.

Customers include pharmaceutical, biotechnology, medical device and diagnostic companies, academic and government institutions, contract research organizations (CROs) and other organizations around the world that are engaged in clinical trials that bring medical products to market and explore new indications for existing products.

According to some accounts, Medidata's Rave product commands a 40% share[2] of the clinical electronic data capture (EDC) market, projected to be $568 million for 2010.[3]

Corporate History[edit]

  • Company founded in June 1999.[4]
  • Acquires Fast Track Systems in March 2008.[5][6][7]
  • Initial public offering (IPO) on NASDAQ in June 2009.[8]
  • Acquires Clinical Force in July 2011.[9][10][11]

Innovation Timeline[edit]

1999-2004

  • 1999 Medidata Solutions introduces its electronic data capture (EDC) system—later named Medidata Rave® in 2002—for use by physician site investigators and company researchers for clinical trials. Provides industry’s first thin-client and web-based system that is browser-independent and operating system-independent. First versions used in academic clinical trials.
  • 2001 Medidata adds Rave web-based administration tools for study setup and configuration management. First pharmaceutical and medical customers begin using system.
  • 2002 Medidata Rave adds new configuration tools for data cleaning ("edit checks") and additional query management for monitoring and data management users.
  • 2003 Medidata Rave adds reporting and data analysis tools.
  • 2003 Medidata Solutions introduces a new e-submission module, a fully automated system for creating bookmarked and hyperlinked electronic clinical report forms (eCRFs) in PDF format.
  • 2004 Medidata Rave adds clinical data management (CDM), becoming industry’s first unified platform for both EDC and CDM.

2005-2009

  • 2005 Medidata Rave extended to become unified platform for study design, EDC, local lab data capture, migration management and reporting, and adds multi-byte language support.
  • 2006 Medidata Rave adds local language translation tool, enabling application screens and study definitions to be presented in any language, and double data entry capability, allowing for paper and paper/EDC hybrid studies to be run on a common platform.
  • 2007 Medidata Rave adds global library and study design editing tools to accelerate study build.
  • 2007 Medidata Rave integrated with Fast Track’s TrialSpace Designer® (TSD) study design software for automatic population of eCRF build from protocol design tool.
  • 2008 Medidata Rave introduces integrated eLearning module to enable investigative sites to complete Rave training directly within system.
  • 2008 Medidata Solutions acquires Fast Track Systems, Inc., adding Medidata Designer® (protocol design tool), Medidata Grants Manager® (for site budget benchmarking) and Medidata CRO Contractor® (for planning and managing CRO contracts).
  • 2008 Medidata Rave certified by the Clinical Data Interchange Standards Consortium (CDISC) for complying with the Operational Data Model (ODM) standard, becoming first organization to be certified in all eight ODM use cases.
  • 2008 Medidata Solutions introduces Rave Web Services application programming interface (API) to enable developers to integrate third-party systems with Rave.
  • 2008 Medidata Rave adds compatibility with clinical data acquisition standards harmonization CDASH standard data collection forms.
  • 2008 Medidata Solutions introduces Medidata Developer Central, web-based community for developers integrating clinical trial solutions with Medidata Rave.
  • 2009 Medidata Rave adds integrated site visit reporting tool.
  • 2009 Medidata Rave Safety Gateway introduced, automatically transfers safety event information to safety systems.

2010–Present

  • 2010 iMedidata™ launched, central portal for access to all Medidata studies, applications and eLearning.
  • 2010 Medidata Rave Targeted SDV introduced to support risk-based monitoring.
  • 2010 Medidata Grants Manager reintroduced as web-based version.
  • 2010 Medidata Balance™ introduced as randomization and trial supply management (RTSM) solution with self-service development tools and pre-integrated with Medidata Rave.
  • 2011 Medidata Solutions introduces Medidata Insights™, a clinical trials analytics tool to help study managers track and benchmark progress of trials and clinical study programs.
  • 2011 Medidata Solutions introduces Medidata Coder™, a centralized coding tool that works out of the box with Medidata Rave.
  • 2011 Medidata Solutions launches Grants Manager Contracting™, computer-enabled negotiation tool for contracting with clinical sites.
  • 2011 Medidata Solutions acquires Clinical Force, adds Medidata CTMS™ (clinical trial management system).
  • 2011 Medidata Solutions announces Medidata Standards Accelerator™ service, providing support for the Clinical Data Interchange Standards Consortium (CDISC) study data tabulation model (SDTM), the FDA’s recommended format for electronic submission of case report form data.
  • 2012 Medidata Balance RTSM solution adds support for block randomization.
  • 2012 Medidata Solutions technology selected for the CDISC Protocol Representation Model (PRM) Wizard.
  • 2012 Medidata Rave Safety Gateway expands its capabilities for sites to electronically transfer non-serious safety case data—in addition to serious safety case data—to sponsors' safety systems.
  • 2012 Medidata Solutions introduces Medidata Grants Manager Investigator Initiated™, designed for sponsors receiving investigator-sponsored proposals from sites.
  • 2012 Medidata CTMS introduces out-of-the-box integration with Medidata Rave.
  • 2012 Medidata Insights adds analytics on patient enrollment
  • 2012 Medidata Designer adds capability to support CDISC PRM standards-based structured study design, enabling further reuse of design information in downstream systems.
  • 2012 Medidata CTMS introduces standards-based infrastructure to import operational data from multiple CRO partners, allowing the viewing of real-time, aggregated operational data.
  • 2012 Medidata Balance RTSM solution offered as a stand-alone system.
  • 2013 Medidata Solutions introduces Medidata Insights™ SQM, the industry's first turnkey site quality management solution.
  • 2013 Medidata Solutions introduces Medidata Patient Cloud™ for the capture and management of patient-reported data.

Industry Recognition[edit]

  • American Business Awards, Best Overall Company, “Stevie Award” category Finalist 2006.[12]
  • Bio-IT World, Best of Show, Clinical Trials and Research category Finalist 2006,[13] eClinical Technologies category Winner 2008.[14]
  • Codie Awards, Software & Information Industry Association (SIIA), Best Medical and Health Information Product category Finalist 2006.[15]
  • Computerworld, Premier 100, IT Leaders, Honored 2011.[16]
  • Crain’s 40 Under 40, Named 2010.[17]
  • Deloitte, Technology Fast 50 Program for New York, Named “Rising Star” 2003,[18] Named 2005.[19]
  • Deloitte Technology Fast 500, Named “Rising Star” 2003,[20] Ranked 70th in 2006,[21] Ranked 247th in 2011,[22] Ranked 338th in 2012.[23]
  • Dpharm, Named "Disruptive Innovator of the Year" 2013.[24]
  • Drug Information Association (DIA), Founders Service Award 2007.[25]
  • Ernst & Young, Entrepreneur Of The Year®, Metropolitan New York Area, Technology Winner 2006,[26] Business Services Winner 2010.[27]
  • FierceBiotech, FierceBiotech’s Top 10 Biotech Techies, Named 2012.[28]
  • Frost & Sullivan, North American Healthcare Information Technologies Entrepreneurial Company of the Year Winner 2006.[29]
  • Inc. 500, Annual List of America’s Fastest-Growing Private Companies, Ranked 59th in 2006.[30]
  • Inc. 5,000, List of Fastest-Growing Private Companies in the United States, Ranked 173rd Overall in 2007.[31]
  • PharmaVOICE, PharmaVOICE 100, Named 2005,[32] 2006,[33] 2007,[34] 2008,[35] 2009,[36] 2010,[37] 2011,[38] 2012.[39]
  • Techie Awards, Healthcare category, Gold Winner 2011.[40]
  • The CenterWatch Monthly's "20 Innovators Changing the Face of the Clinical Trials Industry," Named 2013.[41]
  • The New York Ten Awards™, 2005.[42]

External links[edit]

References[edit]

  1. ^ Yahoo! Finance
  2. ^ clinpage.com, February 2007
  3. ^ IDC Health Insights, February 2010
  4. ^ S-1 filing, January 26, 2009
  5. ^ Bio-IT World, March 18, 2008
  6. ^ Clinpage, April 30, 2008
  7. ^ PharmaTimes, March 19, 2008
  8. ^ Prospectus, June 25, 2009
  9. ^ Contract Pharma, June 20, 2011
  10. ^ Pharma Times, June 21, 2011
  11. ^ Outsourcing-Pharma.com, November 9, 2011
  12. ^ "2006 Company, Office & Product Stevie Award Winners & Finalists," Stevie Awards, Inc. Retrieved June 29, 2012
  13. ^ "Bio-IT World Magazine Announces Best of Show Awards Finalists," Bio-IT World. Retrieved June 29, 2012
  14. ^ "Best of Show Awards Winners Named at Bio-IT World Conference & Expo," Bio-IT World, May 2, 2008.
  15. ^ Business Wire, January 26, 2006
  16. ^ "Class of 2011 Yearbook: The Honorees," Computerworld. Retrieved on June 29, 2012
  17. ^ "40 Under Forty," Crain Communications Inc. Retrieved June 29, 2012
  18. ^ Business Wire, November 4, 2003
  19. ^ Business Wire, November 3, 2005
  20. ^ "Deloitte Technology Fast 500," Deloitte, 2003. Retrieved June 29, 2012
  21. ^ "2006 Technology Fast 500," Deloitte Development LLC, 2006. Retrieved on June 29, 2012
  22. ^ Business Wire, November 10, 2011
  23. ^ Business Wire, November 16, 2012
  24. ^ The Conference Forum, September 30, 2013
  25. ^ Business Wire, June 11, 2007
  26. ^ Business Wire, June 29, 2006
  27. ^ "Ernst & Young Entrepreneur Of The Year," Ernst & Young. Retrieved on June 29, 2012
  28. ^ Fierce BiotechIT, March 23, 2012
  29. ^ Frost & Sullivan, October 30, 2006
  30. ^ Business Wire, September 7, 2006
  31. ^ Business Wire, September 5, 2007
  32. ^ Business Wire, August 17, 2005
  33. ^ Business Wire, July 25, 2006
  34. ^ Business Wire, July 24, 2007
  35. ^ Business Wire, July 28, 2008. SYS-CON Media, Inc.
  36. ^ "The PharmaVOICE 100." PharmaVOICE, July/August 2009: 110
  37. ^ "The PharmaVOICE 100." PharmaVOICE, July/August 2010: 98
  38. ^ "The PharmaVOICE 100." PharmaVOICE, July/August 2011: 174
  39. ^ "The PharmaVOICE 100." PharmaVOICE, July/August 2012
  40. ^ Techie Awards, 2011. Retrieved on June 29, 2012
  41. ^ "20 Innovators Changing the Face of the Clinical Trials Industry." The CenterWatch Monthly, April 2013, Volume 20, Issue 04: 22
  42. ^ Ten Awards, 2005. Retrieved on June 29, 2012