Smooth Drug Development announces ISO 27001 certification for information security management in clinical trials

Logo Smooth Drug Development

ISO Certified

Implementing an ISMS guarantees confidentiality, integrity, and availability of information security and clinical trial data and minimizes the risks.

ISO 27001 certification strengthens our position as a leading CRO in Eastern Europe”

— Dmitry Morozovsky, MD, EMBA, CEO

WILMINGTON, DELAWARE, USA, April 7, 2021 / — As digitalization is the main common trend of the clinical trials industry today it creates both significant opportunities and great risks as company and clinical trial data could be lost or corrupted.

Implementing and certifying an Information Security Management System (ISMS) guarantees confidentiality, integrity, and availability when it comes to information security of the company and clinical trial data and minimizes the possible risk of fraud, information loss and disclosure.

Smooth Drug Development took a systematic approach to managing company data and information, implemented and certified its own Information Security Management System in compliance with ISO/IEC 27001. Certification was validated following an audit performed by the independent certification body, G-CERTI.

This certification compliments Smooth Drug Development current certifications in ISO 9001 “Quality Management Systems” and ISO 22301 “Societal security – Business continuity management systems – Requirements” which prove our company’s continuous improvement of our overall performance and focus on providing customers with products and services of consistent quality and our company’s maintenance of effective business continuity plans, systems and processes.

Conformity with the internationally recognized standard of ISO 27001:2013 lies at the core of Smooth Drug Development approach to implementing and managing information security, as it proves the completeness and highest level of security controls while providing clients with an additional level of assurance. ISMS covers all aspects of Smooth Clinical Trials Management System which is used for Project and Data Management, eTMF/eISF, ePRO, eLearning etc.

The benefits and guarantees of ISO 27001 for Clinical Trial sponsors are:

• Data and System Integrity
• Physical and Logical Security
• Privacy Protection
• Security Controls
• Risk and Incident Management

“By enhancing our Information Security Management System, we reinforce our credibility and demonstrate integrity of all our systems which are used in our daily activities. We are happy to demonstrate to existing and potential customers, suppliers Smooth Drug Development commitment to information security. ISO 27001 certification strengthens our position as a leading CRO in Eastern Europe”, said Dmitry Morozovsky, MD, EMBA, CEO.

The certification covers all aspects of clinical trials, observational programs, pharmacovigilance, and drug marketing activities.

About Smooth Drug Development (

Smooth Drug Development is a CRO with the most advanced electronic solutions in clinical trials. The company offers a full range of clinical development services in Eurasia.

Julia Sardaryan
Smooth Drug Development
+1 302-660-0614
email us here

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