20 December 2017 News

Data Management 365 presented at Quality Assurance Forum

Anna Petrovskaya, our QA Manager, attended Quality Assurance Forum held in Skolkovo, Moscow on December, 15th. This meeting gathered QA specialists from all over Russia to share knowledge and experience of quality assurance in clinical studies industry.

Anna covered a topic on personal data protection in clinical studies and highlighted the legislative requirements in the field of personal data protection set by Russian (Federal Law 152-) and European (General Data Protection Regulation) governments. Personal data protection is a very hot and important topic as GDPR will come into effect starting May 25th, 2018, and the industry is getting prepared to this date.

One of the major priorities of Data Management 365 is personal data protection, as we work with data from our clients, sponsors and study subjects. Data Management 365 is always ready to support our clients, share our knowledge and provide guidance. We have already appointed Data Protection Officer, who is involved in all issues related to the protection of personal data. We ensure that the data centers used for our clients data storage are located according to the data protection regulations requirements. We have implemented two core principles set by GDPR: data protection by default and data protection by design. We provide our clients with convenient tools to collect the necessary data and selectively avoid collection of any extra, unnecessary data. This warrants the complete and consistent data set by the end of the trial and minimizes the amount of data for processing. We also provide effective tools for data anonymization.