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Powering smarter treatments and healthier people
|Traded as||NASDAQ: MDSO
S&P 600 Component
|Industry||Clinical development technology
Software as a service
|Founded||New York City, USA (1999)|
|Founder||Glen de Vries
Edward Ikeguchi, MD
|Headquarters||350 Hudson Street, New York, NY, United States|
|Tarek Sherif (CEO)
Tarek Sherif (Chairman)
Glen de Vries (President)
Medidata Grants Manager
Medidata CRO Contractor
Medidata Patient Cloud
Medidata Rave Safety Gateway
|Revenue||$392.5 million (2015)|
Number of employees
|1,500+ (December 31, 2015)|
Medidata Solutions is an American-based global SaaS technology company that specializes in developing and marketing a cloud-based platform of applications and data analytics to address operations throughout clinical trials. The Medidata Clinical Cloud® platform is designed to improve clinical study design and planning through execution, management and reporting. Specific technology areas include protocol development, clinical site collaboration and management, randomization and trial supply management, capturing patient data through web forms, mobile health (mHealth) devices, laboratory reports and imaging systems, quality monitor management, safety event capture, and business analytics.
Headquartered in New York, New York, Medidata employs 1500+ people worldwide as of 2016. Medidata Solutions has a total of 11 offices with locations in the United States, the UK, Japan, China, South Korea and Singapore.
Medidata’s customers include pharmaceutical, biotechnology, medical device and diagnostic companies, academic and government institutions, contract research organizations (CROs) and other life sciences organizations around the world that develop and bring medical therapies and products to market. The Medidata platform has been used by more than 600 customers around the world, supporting more than 10,000 clinical studies, 370,000 investigational sites and more than 2.7 million trial volunteers.
- Company founded in June 1999.
- Acquires Fast Track Systems in March 2008.
- Initial public offering (IPO) on NASDAQ in June 2009.
- Acquires Clinical Force in July 2011.
- Acquires Patient Profiles, LLC in October 2014.
- Acquires Intelemage in April 2016.
- 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 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 iMedidata™ launched, central portal for access to all Medidata studies, applications and eLearning.
- 2010 Medidata TSDV 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 SQM, the industry's first turnkey site quality management solution.
- 2013 Medidata Solutions introduces Medidata Patient Cloud ePRO for the capture and management of patient-reported data.
- 2014 Medidata Solutions acquires Patient Profiles, an early-stage software company focusing on the statistical evaluation of clinical trial data quality.
- 2014 Medidata Solutions conducts method development project in partnership with global pharmaceutical company GSK to evaluate the impact of unifying mobile health (mHealth) devices with cloud-based technologies in a clinical trial setting.
- 2015 Medidata Solutions integrates Garmin’s vívofit activity tracker with the Medidata platform to expand mobile health (mHealth) capabilities.
- 2015 Medidata Solutions builds open-source connector linking Apple ResearchKit with the Medidata Clinical Cloud platform.
- 2015 Medidata Solutions integrates Validic’s digital health platform with the Medidata Clinical Cloud platform to expanding access to patient-generated data from a broad range of consumer and medical grade mHealth devices and apps.
- 2015 Medidata Solutions introduces Operational Performance Analytics (OPAL) dashboard to measure and manage the operational performance of clinical development programs.
- 2016 Medidata Solutions introduces AppConnect, a regulatory-compliant software development kit (SDK), compatible with Apple® ResearchKit and other third-party toolsets, that enables the integration of custom apps with the Medidata platform.
- 2016 Medidata Solutions introduces SensorLink, a regulatory-compliant tool enabling the integration and ingestion of data from sensors and wearables into the Medidata Clinical Cloud.
- 2016 Medidata expands its site payment solution, Medidata Payments, to include tax identification and calculation and global disbursement capabilities.
- 2016 Medidata Solutions acquires Intelemage, a medical image sharing and workflow management company.
- American Business Awards, Best Overall Company, “Stevie Award” category Finalist 2006.
- Bio-IT World, Best of Show, Clinical Trials and Research category Finalist 2006, eClinical Technologies category Winner 2008.
- CARE Awards, “Best Technological Development in Clinical Trials” and “Partnership of the Year” Categories, Named Finalist 2016.
- Codie Awards, Software & Information Industry Association (SIIA), Best Medical and Health Information Product category Finalist 2006.
- Computerworld, Premier 100, IT Leaders, Honored 2011.
- Crain’s 40 Under 40, Named 2010.
- Deloitte, Technology Fast 50 Program for New York, Named “Rising Star” 2003, Named 2005.
- Deloitte Technology Fast 500, Named “Rising Star” 2003, Ranked 70th in 2006, Ranked 247th in 2011, Ranked 338th in 2012.
- Dpharm, Named "Disruptive Innovator of the Year" 2013.
- Drug Information Association (DIA), Founders Service Award 2007.
- Ernst & Young, Entrepreneur Of The Year®, Metropolitan New York Area, Technology Winner 2006, Business Services Winner 2010.
- FierceBiotech, FierceBiotech’s Top 10 Biotech Techies, Named 2012.
- Fortune’s “Great Places to Work,” Certified 2016.
- Frost & Sullivan, North American Healthcare Information Technologies Entrepreneurial Company of the Year Winner 2006.
- Healthcare Businesswomen’s Association, Industry Rising Star, Named 2014, 2015
- Inc. 500, Annual List of America’s Fastest-Growing Private Companies, Ranked 59th in 2006.
- Inc. 5,000, List of Fastest-Growing Private Companies in the United States, Ranked 173rd Overall in 2007.
- InformationWeek, Elite 100 List, Named Finalist 2016
- Journal of mHealth, Global Digital Health 100, Awarded 2015.
- MD+DI, Med Tech Company of the Year, Named Reader’s Choice 2015.
- New York State Society for Human Resource Management (NYS-SHRM), “Best Companies to Work for in New York State,” Named 2015.
- Patient Engagement App Challenge, Winner of "Large Organization Recognition" Award for "Engage" App Prototype at 23rd Annual Partnerships in Clinical Trials Conference 2014.
- PharmaVOICE, PharmaVOICE 100, Named 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2014, 2015
- Scrip Awards, “Best Technological Development in Clinical Trials” and “Executive of the Year” (Glen de Vries) Categories, Named Finalist 2015.
- Techie Awards, Healthcare category, Gold Winner 2011.
- The CenterWatch Monthly's "20 Innovators Changing the Face of the Clinical Trials Industry," Named 2013.
- The New York Ten Awards™, 2005.
On September 16, 2014, a Medidata accounting employee received an e-mail message that appeared to be from a company executive requesting a transfer of nearly $4.8 million to a bank account in China in regard to an acquisition. After receiving approval from two supervisors who also received similar e-mails, the money was transferred. When the transaction request was discovered to have been a fraud, Medidata filed an insurance claim, which was denied by its insurer, Federal Insurance Co., a subsidiary of Chubb Ltd. At issue was Federal Insurance’s claim that its policy only covered losses resulting from fraudulent entry or hacking into a computer system, and not voluntary transfers perpetuated by manipulation” while Medidata asserted that “the policy’s plain language defines data as ‘any information” in Medidata’s computer system.” On March 10, 2016, a New York federal judge refused both parties’ requests for summary judgment saying that there was not enough evidence to make a ruling. The fraudsters were never identified, and the transferred funds were never recovered. Neither side has filed any additional claims.  
On March 15, 2017, the company's Japan subsidiary, Medidata Solutions K.K., was found to have wrongfully dismissed its Tokyo IT Director in 2015 after the company had asked him to fly from Tokyo to New York to receive the notice, which occurred weeks after he had filed two ethics reports on his boss for a nepotism hire and failure to address a security hole. The Tokyo District Court ruled that the company, which had sued the employee after he refused to voluntarily resign and was unilaterally dismissed, had not satisfied any of the four prerequisites from the Doctrine of Abusive Dismissal, which are necessary for a restructuring dismissal in Japan. As a result of the judgment, all back salary and bonuses in excess of 30 million yen were ordered to be paid, and the company has a legal obligation to continue to employee the man whose status as an employee was affirmed by the court. 
On January 26,2017, Medidata filed a lawsuit in New York federal court against five former VP level employees and Veeva Systems Inc. for breach of contract related to noncompete contract clauses and theft of trade secrets and confidential information. The complaint asserted that Veeva has been deliberately targeting Medidata employees, naming 11 junior level employees who had been hired by Veeva over the past two years as well as the unsuccessful solicitation of at least five additional senior level Medidata employees. The company is seeking injunctive relief and damages to be determined at trial. 
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