10 April, 2023

Clinical trials are a key part of the drug development process, as they employ human or animal subjects to determine if a new test or treatment is safe. Treatments may be new pharmaceutical drugs, new combinations of drugs, new medical procedures or devices, or new ways to use existing treatments. A clinical trial is performed by medical research organizations led by a principal investigator, typically a medical doctor, assisted by a team of lab assistants, nurses, and other healthcare professionals. The clinical trial may be performed by a Contract Research Organization (CRO), under contract to a pharmaceutical firm, medical device maker, or other research product or device development company.

The safety of clinical trials is protected under US federal Food and Drug Administration (FDA) rules, which requires reviewing and monitoring of the trial by an Institutional Review Board (IRB). Along with the IRB, many clinical trials are closely supervised by a Data and Safety Monitoring Committee, which monitors clinical trials to ensure that patient information remains private, in accordance with HIPAA (Health Insurance Portability and Accountability Act) regulations.

Given the critical need to maintain privacy and protect proprietary product information, clinical research organizations need a secure document security solution: a virtual data room (VDR). A virtual data room is an online platform for securely storing and sharing files and documents, with an array of enterprise-grade security protections, for both users and documents. Among VDR providers, ShareVault stands out as the VDR of choice for the life sciences: ShareVault has been serving the biotech industry for more than 15 years and has been named as the preferred Business Solutions Program provider by the Biotechnology Innovation Organization (BIO) and more than 50 other life science trade organizations.

Here are some ways a ShareVault VDR can help secure clinical trial information:

Restricted Access and Data Encryption

Clinical trial organizations need to protect their sensitive information from competitors, hackers, and unauthorized users. With ShareVault, patient health information (PHI) is secure in its VDR environment, which complies with HIPAA's strict privacy regulations.

ShareVault’s robust security features include:

Once the clinical trial team members are in the secure VDR environment, they can access databases and document archives and generate and share new documents exactly as they would normally do, using Word, Excel, and other software. Access can be extended to partner labs, pharmaceutical and device manufacturers, and other third parties, including regulators. These third-parties will be subject to the same security protocols, including registration of their device IP address.

Version Control and Access Logs

Clinical trial data can be vast and complex, with multiple versions and iterations of the same document. The ShareVault VDR includes software to make version control easier to manage:

Collaboration and Activity Monitoring

A ShareVault VDR is designed to allow multiple parties to collaborate and share data securely. This can be particularly useful in clinical trials where various parties may need to access and collaborate on the same data. This includes pharmaceutical companies, researchers, and regulatory bodies. A VDR can facilitate this collaboration while confirming that the data remains secure and confidential.

A ShareVault VDR provides a comprehensive audit trail, allowing administrators to monitor all activity within the VDR. This helps all parties follow the appropriate protocols and ensures that data is handled securely. Activity monitoring can help verify compliance with clinical trial data management regulatory requirements. Regulatory organizations like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have strict guidelines on how clinical trial data should be managed and accessed. Monitoring user activity within the virtual data room can help demonstrate that these guidelines are being followed, providing transparency and accountability.

Protect Your Data with a ShareVault Virtual Deal Room

Clinical trials can be a long and challenging process involving many users and groups, including ones outside of your organization. ShareVault has deep experience working with clinical trial organizations as well as pharma, biotech, medical device manufacturers, and other life science organizations. When advice or technical input is needed, ShareVault’s experienced support team is available, 24/7/365.

To learn more about how a ShareVault virtual data room can improve the speed and security of your clinical trial, contact us today!

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