Virtual data rooms (VDRs) are revolutionizing how pharmaceutical companies manage clinical trial data by providing a secure platform for storing and sharing confidential data in compliance with regulatory bodies such as the FDA.
What role do VDRs play in managing clinical trial data? Why are VDRs the new gold standard, and why should pharmas use them for clinical trial data management? Before investigating these questions, let’s highlight the need for data security safeguards and the risks of mismanagement.
Life science and biotech companies are subject to stringent regulations governing various aspects of business, including data security laws.
Data privacy and security laws, such as the Health Insurance Portability and Accountability Act (HIPAA), demand a high level of data safeguards to ensure that electronic protected health information (e-PHI) remains inaccessible to unauthorized parties.
Pharmas are obligated to conduct comprehensive risk analysis, address known risks, and enact a proactive and provable approach to risk management. These companies must ensure that any IT they use is equipped with gold-standard data security safeguards, including encryption.
“Risk analysis should be an ongoing process, in which a covered entity regularly reviews its records to track access to e-PHI and detect security incidents, periodically evaluates the effectiveness of security measures put in place, and regularly reevaluates potential risks to e-PHI,” advises the U.S. Department of Health and Security in its Summary of the HIPAA Security Rule.
Failure to comply with applicable data security laws can result in costly civil and criminal penalties and reputational damage. Resulting fines and legal fallout may cripple the progress of a clinical trial, compromise the future of the company and cause irrevocable harm to patients involved in the trial.
Virtual data rooms can help life science and biotech companies conduct comprehensive risk analysis, effectively mitigate risks, and proactively protect confidential data.
Recommended reading: The Role of Virtual Data Rooms in Regulatory Compliance
6 Reasons to Use a VDR for Managing Clinical Trial Data
In practical terms, how does a VDR help pharmaceutical companies address these risks, managing clinical data while prioritizing compliance?
Let’s highlight just six benefits virtual data rooms can bring to clinical trial data management.
1. Military-Grade Data Security
Encryption is now the gold standard for data security. How does it work?
“Advanced Encryption Standard (AES) is a highly trusted encryption algorithm used to secure data by converting it into an unreadable format without the proper key,” explains GeeksforGeeks. “This data security measure is efficient and widely implemented in securing internet communication, protecting sensitive data, and encrypting files. AES, a cornerstone of modern cryptography, is recognized globally for its ability to keep information safe from cyber threats.”
Worth noting: CapLinked’s VDR solution is outfitted with military-grade 256-bit Advanced Encryption Standard and is both HIPAA and SOC 2-compliant.
2. Next-Level Organization Capabilities
Biotech and life science companies may simultaneously conduct several clinical trials, each with massive amounts of documentation that must be properly organized, stored, and retained in compliance with relevant regulations.
VDRs are outfitted with customizable folder structuring capabilities to help pharmaceutical companies organize clinical trial documentation into logical groupings. This level of organization helps pharmas to make sure data is easily accessible by authorized parties and ensures more efficient data analysis.
3. Efficiency-Boosting Collaboration Tools
Effective project management is an essential component of any successful clinical trial since these research projects often involve many entities, from sponsors and doctors to participants and regulators.
VDRs give all relevant parties to a clinical trial a centralized, secure portal for communication with customizable permissions and access. Additionally, configurable notifications and built-in instant messaging tools promote collaboration and prevent costly delays.
4. Audit-Ready Reporting for Increased Transparency
A key compliance cornerstone is maintaining an auditable document activity trail. Activity trackers are necessary for enabling both internal and external audits. Using a VDR with a comprehensive document activity tracker promotes integrity and transparency while leading to more informed decision-making.
“Audit trails provide a means to verify the quality, authenticity, and integrity of data, allowing reconstruction of significant details about clinical investigation conduct and source data collection,” says the FDA’s guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers. “All audit trail documentation on the creation, modification, and deletion of electronic records must be available for FDA inspection.”
Modern VDRs allow pharma companies to maintain comprehensive records of all document activity and generate custom reports detailing these actions, including document changes, views, downloads, permissions changes, and more.
5. Built-In Permissions Controls
Of course, not all parties involved in a clinical trial will be authorized to have the same access to trial data. Lab techs, investors, study coordinators, principal investigators, regulatory bodies, and participants all require different levels of access permissions.
VDRs allow administrators and document owners to manage who has access to the portal and which documents they can view, edit, download, and print. Digital rights management (DRM) features act as a safeguard around sensitive data and even allow document owners to rescind access to a given user if they are no longer authorized to access the data in question.
6. Top-Security Document Sharing
Companies conducting clinical trials regularly share trial data internally and with external parties, such as sponsors and regulatory bodies. However, this confidential data can be subject to security risks if shared using insecure methods, such as emailing or using standard file-sharing apps.
Virtual data room technology allows for the secure sharing of sensitive data amongst trusted parties while retaining document control and mitigating risks.
Is there a VDR solution that ticks all of the above boxes? Yes.
Cutting Edge Clinical Trial Data VDR Solution
CapLinked delivers pharma companies an enterprise-level solution for managing clinical trial data. Our virtual data room includes all of the above features and beyond to help life sciences and biotech companies maximize efficiency without compromising compliance.
Our clinical trial data VDR technology helps pharma companies when:
- Submitting regulatory documents
- Navigating mergers and acquisitions
- Raising capital and communicating with investors
- Storing sensitive clinical trial documents
- Collaborating with third parties
- Monitoring and controlling confidential document access
- Facilitating internal and external audits
- Analyzing clinical trial results
- More
At CapLinked, we offer an end-to-end solution for clinical trial data management. Our user-friendly interface gives all authorized parties a secure and centralized portal to collaborate, analyze data, and interact with regulatory bodies to move forward with the trial in full compliance.
Work with us to create a fully customized virtual data room solution for your enterprise.
