Data Security Technology for Clinical Trials
Vast amounts of data are collected and distributed throughout the lifecycle of any clinical trial. Secure data management and participant security guidelines are therefore indispensable tools in the maintenance and organization of your data. At ethica CRO, we follow robust SOPs and guidelines, and have implemented trustworthy, state-of-the-art technologies to ensure efficient data organization, transparency, and security, both during and after completion of your study.
Our data security initiatives will:
Ensure participant confidentiality through secure servers, de-identification processes, and encryption technologies
Protect your study data in order to ultimately secure your intellectual property
Allow for private and secure communication between all parties involved in your study
Do you want to learn more about how we can ensure the security of your study data?
Our Technological Data Security Services
Our clinical and data management staff is highly trained in the implementation and use of a multitude of Electronic Data Capture (EDC) platforms. All EDC platforms used by ethica CRO respond to a variety of study design logistical requirements and have been subjected to a thorough vendor qualification process focused on data integrity and the protection of research participants’ personal information.
We have expertise with the following EDC platforms:
- IBM Clinical Development
- Medidata Rave
- Oracle InForm
For more information about the various platforms we use at ethica CRO, please visit our EDC Systems and eTMF pages in our Technology section.
Our Data Security Approach
Our Data Security Policies
We ensure that your clinical trial study is compliant to all local and international regulations regarding the management of patient information and data security. Our processes and SOPs ensure compliance with HIPAA (Health Insurance Portability and Accountability Act), PIPEDA (Personal Information Protection and Electronic Documents Act), and GDPR (General Data Protection Regulation).
Sensitive research participant information is managed using our centralized EDC databases, where all identifiers are removed from the data to ensure research participants confidentiality. Through remote data monitoring, regular system back-ups, and risk mitigation strategies, we are constantly ensuring that your data is secure, viable, and error-free. All study documentation, data, and communications are shared between parties using password-protected, encrypted software.
Lastly, not only do we ensure the security of your data, but we also provide transparency and accessibility. Raw data entered into EDC is processed and displayed in customized data dashboards that allow for real-time access to study and data metrics as well as rapid creation of study-specific reports and meeting presentation materials.