Medidata Solutions is an American-based company developing SaaS solutions for clinical trials. 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 has 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, CROs and other life sciences organizations around the world that develop and bring medical therapies and products to market.

The company was founded in June 1999. It acquired Fast Track Systems in March 2008. It made its initial public offering (IPO) on NASDAQ in June 2009.

It acquired Clinical Force in July 2011, acquired Patient Profiles, LLC in October 2014, and acquired Intelemage in April 2016.

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.