Waltham, Massachusetts – March 3, 2023 – Today, OpenClinica  announced the company successfully completed a System and Organization Controls (SOC) 2 examination. The examination and audit  was carried out by an independant third-party CPA firm and underscores OpenClinica’s ongoing commitment to effective controls over the security, availability, processing integrity, confidentiality and privacy of its electronic data capture platform.

A SOC 2 report is designed to meet the needs of existing or potential customers seeking assurance about the effectiveness of controls used by the service organization to process customer information.

The SOC 2 report verified we have the appropriate controls in place to mitigate risks related to security, availability, processing integrity, confidentiality and privacy of the data entrusted to us,” said Cal Collins, company co-founder and CEO. “As stewards of sensitive healthcare data, security is foundational to everything we do.”

The following principles and related criteria were developed by the American Institute of CPAs (AICPA) for use by practitioners in the performance of trust services engagements:

  • Security: The system is protected against unauthorized access both physical and logical.
  • Availability: The system is available for operation and use as committed or agreed.
  • Processing Integrity: System processing is complete, valid, accurate, timely and authorized to meet the entity’s objectives.
  • Confidentiality: Information designated as confidential is protected as committed or agreed.
  • Privacy: Personal information is collected, used, retained, disclosed and disposed of to meet the entity’s objectives.

A SOC 2 report is an internal control report on the services provided by a service organization to its customers and provides valuable information that existing and potential customers of the service organization need to assess and address the risks associated with an outsourced service.

Current and prospective customers interested in a copy of the SOC 2 report may contact Laura Keita, Senior Director, Compliance at

About OpenClinica

OpenClinica accelerates clinical trials by automating data acquisition through its software-as-a-service platform. Offering a secure bridge between healthcare and research, OpenClinica is trusted by the world’s foremost life science companies, academic institutions, and government entities and has been used in more than 10,000 studies involving over five million patients. OpenClinica is proud to support hundreds of small, midsize and large research organizations spanning biotech, pharma, medical device manufacturing and contract research organizations.

Learn more at or contact us.



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