CLEVELAND, August 24, 2018 /PRNewswire/ — DATATRAK International, Inc. (OTC Markets: DTRK), a Software-as-a-Service (SaaS) provider and innovation leader of cloud-based technologies for the life sciences industry, today announced that it has successfully completed the General Data Protection Regulation (GDPR) compliance program earlier this year along with System and Organization Controls (SOC) 2® Type II Audit reexamination for their DATATRAK SaaS, Enterprise Cloud.
The SOC recertification coincides with DATATRAK’s GDPR compliance program which was put into place before the deadline of May 25, 2018. Internal system audits were conducted, and all employees were personally trained on the new European regulatory requirements. “We have always taken the security of our system very seriously,” said Amy Boukair, Director, Quality Assurance. “The new DATATRAK GDPR compliance for harmonized data protection across the EU is just another way for us to put our European Clients’ minds at ease that their clinical trials are always in safe hands, no matter where the trial subjects are located.”
According to a recent survey performed by TrustArc, only 20% of companies have fully completed their GDPR implementations, even months after the requisite deadline. With its ongoing global compliance program, DATATRAK continues to lead the way in the industry focusing on technological advancements, data security, and regulatory expertise.
The SOC 2® Type II report is performed by an independent auditing firm and is intended to provide an understanding of the service organization’s suitability of the design and operating effectiveness of its internal controls. A service organization may select any or all of the trust service principles applicable to their business and DATATRAK chose to report on security, availability, processing integrity and confidentiality. The successful completion of this voluntary engagement illustrates DATATRAK’s ongoing commitment to create and maintain a secure operating environment for their clients’ confidential data. DATATRAK International, Inc. retained international business advisory firm Skoda Minotti for its SOC 2® audit work.
Skoda Minotti’s testing of DATATRAK’s controls included an examination of their policies and procedures regarding network connectivity, firewall configurations, systems development life cycle, computer operations, logical access, data transmission, backup and disaster recovery, and other critical operational areas of their business. Upon completion of the audit, DATATRAK received a Service Auditor’s Report with an unqualified opinion demonstrating that their policies, procedures, and infrastructure meet or exceed the stringent SOC 2® criteria.
“The successful completion of our SOC 2® Type II reexamination audit provides DATATRAK’s clients with the assurance that the controls and safeguards we employ to protect and secure their data are in line with industry standards and best practices,” said Scott DeMell, VP of Sales. “This is the type of security that customers have come to expect from a quality EDC vendor, and this type of recertification proves our continuing commitment to that level of assurance.”
DATATRAK International is a worldwide technology and services company delivering unified eClinical solutions and related services for the clinical trials industry. DATATRAK built its multi-component, comprehensive solution on a single, unified platform. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. The DATATRAK Enterprise Cloud, deployed worldwide through an ASP or Enterprise Transfer offering, supports Pre-clinical and Phase I – Phase IV drug and device studies in multiple languages throughout the world.
The DATATRAK Enterprise Cloud includes the following products: Clinical Trial Management System (CTMS), Design, Electronic Data Capture (EDC), Medical Coding, Risk Based Monitoring, ECG Data Capture, Image Data Capture, Randomization, Clinical Supply Inventory, eConsent, ePRO and Business Analytics.
About – Skoda Minotti
Skoda Minotti is a Certified Public Accounting Firm based in Cleveland, OH offering a variety of tax, finance, and business advisory services in virtually every area of business. The Risk Advisory practice specializes in SOC Reporting, PCI DSS Compliance, HIPAA Compliance and HITRUST validation, FISMA, NIST, and other regulatory information security assessments. Staff in Skoda Minotti’s Risk Advisory hold several industry certifications including Certified Information Systems Auditor (CISSA), Certified Information Systems Security Professional (CISSP), Qualified Security Assessor (QSA), GIAC Penetrations Tester (GPEN), and GIAC Web Application Penetration Tester (GWAPT). For more information about Skoda Minotti’s Risk Advisory Services, please visit risk.skodaminotti.com.