How Egnyte Enables Secure File Sharing and Collaboration for CROs
As a contract research organization (CRO), your greatest responsibility is to be a reliable partner to the sponsor in executing a clinical trial. This can include tasks such as writing the study protocol, collecting and submitting data to the FDA, and monitoring sites throughout the study. To honor that responsibility, a CRO must have the right tools and skills to securely share trial data and collaborate with the sponsor.
This article will explore what is at stake when it comes to CRO-to-sponsor data sharing and collaboration, and how CROs can leverage Egnyte to give study sponsors confidence that trial data is secure, compliant, and properly governed.
Keeping Data in the Right Hands
Clinical trial data is highly sensitive - it contains mountains of personal identifiable information (PII) and protected health information (PHI) such as trial participants’ birth dates, addresses, and blood types. It also contains proprietary information that trial sponsors count on – if the trial is successful – to secure a period of market exclusivity.
For these reasons, it’s critical to grant and manage data access on a strict need-to-know basis. If the wrong department or partner gains access to a given piece of data, it can quickly spell trouble. That partner may not be qualified to handle the data, or may not be informed as to its nature or utility. As a result, they can misuse it, misinterpret it, or even alter it inappropriately.
The fallout from an incident like this can have major compliance implications. Regulatory scrutiny in clinical trials is intense, and only getting more so. Controlling access to data and providing audit trails is one of your most important tools for demonstrating that you’re collecting and managing data in a compliant fashion.
- Does your current method of collaboration ensure that data is accessible only to the right stakeholders, whether internal or external?
- Is the solution nimble enough to make it easy to set varying levels of permissions for different files and datasets?
Controlling How Data is Shared
While the prevalence of CRO outsourcing has made external file sharing a critical function of clinical research, the large volumes of data inherent to any clinical trial make remote collaborators vulnerable to myriad challenges while carrying out this function. CROs are tasked with ingesting large datasets from lab instruments and enabling external stakeholders to access, review, analyze, modify, and approve the data. They need visibility into the version history of each file, so that stakeholders aren’t working with outdated material. And when they’re done, they need to be able to send the data back to the sponsor securely.
Without the right technology, each of these areas represents a potential failpoint that can jeopardize the integrity and security of the data. If a CRO falls out of compliance or experiences a security breach during a data exchange, it’s the sponsor who is ultimately responsible for that lapse – and they’re quick to pass that responsibility onto their vendor. CROs hoping to please their clients and win repeat business, then, had better be able to show sponsors that they have the ability to ensure security and compliance as data passed between CRO and sponsor stakeholders.
- Can you share data with the necessary stakeholders easily, quickly, and – most importantly – securely?
- How easy is it for stakeholders to locate, review and share data sets from remote locations?
How Egnyte Keeps File Sharing and Collaboration Secure
The primary reason so many CROs have made Egnyte’s cloud-based solution a permanent part of their tech stack is that, unlike traditional solutions, Egnyte was built specifically with CRO-sponsor collaboration in mind. Here is a short review of some of the unique platform capabilities.
Secure File Links
Email attachments are among the least secure ways to collaborate. As soon as a trial stakeholder clicks the button to email a file attachment to a collaborator, that stakeholder loses visibility into who has access to the file. They have no way to determine, in a timely fashion, whether that file has been intercepted or by whom, if it has been downloaded or altered, and where the latest version now resides. In short, they’ve lost almost all control.
In Egnyte, collaborators can exchange data through secure, shareable links, instead of relying on high-risk email attachments. And they can rest assured that those links are GxP- and CFR Part 11-complaint.
Collaborators also can gain visibility into any breaches that do occur – no system is completely failsafe, after all – and take swift action to neutralize them. As an example, let’s consider a CRO based in North Carolina who is collaborating with a sponsor in Boston. If the CRO sends the sponsor a link to a file, Egnyte will immediately and automatically alert them in the event that the link is accessed in, say, Australia. From there, the CRO can kill the compromised link and revoke access.
Trial administrators can leverage a broad suite of features that give them full control over how both internal and external collaborators manage and share content. These features unlock myriad capabilities for collaborators, such as:
- Ensuring that only those with Egnyte licenses can receive the link.
- Password-protecting the link.
- Restricting recipients from downloading the linked document.
- Provisioning different levels of access, such as edit or view-only.
File sharing and collaboration are inherent to CRO-sponsor relationships in clinical trials. Choosing the right technology is a critical step for CROs in making sure their collaboration is secure and compliant and meets their sponsors’ needs. To see Egnyte’s solution in action, read how Vial, a next-generation tech-enabled CRO uses the platform to securely upload, download, share and collaborate on content with sponsors - without losing control.
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