15 November, 2022

A Virtual Data Room (VDR) allows biotech professionals to share confidential information with project teammates, labs, manufacturers, and other partners in the product development pipeline. When a development project reaches an endpoint, regulators and investors or potential partners can be invited to view documents in the VDR’s secure environment.

ShareVault is the leading virtual data room provider to the biotech and life sciences market, and has been selected by the Biotechnology Innovation Organization (BIO) and more than 50 other life science industry trade associations for their Business Solutions Program.

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Enhanced Features

ShareVault’s VDR is a secure workplace for biotech. Access to the VDR is strictly controlled by a company’s VDR administrator, who controls who has access to files and what permissions are allowed, such as view, edit, share, download, and print. Each authorized user enters the VDR environment with two-factor authorization of a password. The administrator can add or subtract users and permissions over the lifetime of a project.

ShareVault’s VDR has features specifically designed for Biotech:

Collaboration solutions: ShareVault’s platform with its many state-of-the-art features provides biotech companies with a secure online platform to store, organize and share documents with team members and potential partners. ShareVault also includes a feature for securing work-in-progress documents known as Dynamic Native File Protection (DNFP). With DNFP, authorized users can create a document by opening Google Docs, Microsoft Word, or PowerPoint from within the VDR. As the document goes through its iterations multiple collaborators can securely add and subtract copy until the report, contract, or due diligence proposal is complete. Users can also use a Comment section to notify other team members of new copy points or to pose a question.

Biotech pros can also use ShareVault’s Collabloop, a built-in software for “redlining” - the collaborative process of editing a document into its final form - perfect for finalizing a proposal, legal contract, due diligence document, or regulatory document submission.

Organize & Search Solutions: In addition to bank-grade security, ShareVault has built-in tools to speed the process of getting organized and finding documents. Since biotech development can include scores of documents, both archival and work-in-progress, fast and easy organization is essential. Here’s how it works with ShareVault:

The administrator creates master folders for documents and organizes them in a logical way. Individual documents are identified with one or more “hierarchical tags” indicating the subject matter, status, or other information.

Documents can be tagged with multiple tags so they show up in multiple locations.

With other solutions, you are required to either put placeholder documents in the appropriate locations that refer to the actual document, or make multiple copies of the file, and place the copies accordingly. In addition to the cost of the additional storage, you'll need to keep track of each of the copies of the same document. With ShareVault, just tag the same file with multiple tags, and the same file will be shown in each location. This clean and elegant approach provides the best of both folders and tags, and it's only available from ShareVault.

Documents can also be designated as “Favorites” allowing a user to come back to the data room at another time and easily locate documents they were reviewing.

A user can also use ShareVault’s powerful search function. A user can type in a keyword, such as “Warranties” and quickly locate all documents containing that term. The user sees search results in context, eliminating the need for a wild-goose chase through multiple search results.

Auditing Solutions: The biotech team administrator can monitor the status of documents as a development program progresses. At any time, the administrator can generate an audit report, complete with user, document, date and time, and status of the document - important information for keeping a development program on track and an essential reporting tool for regulatory agencies.

Regulatory compliance: ShareVault Data Rooms are 21 CFR Part 11 Compliant. When regulatory submissions are required, ShareVault’s enterprise-grade secure VDR is the preferred platform for sharing:

  • Electronic Trial Master Files (ETMF)
  • Investigational New Drug (IND) applications
  • New Drug Applications (NDA)
  • Abbreviated New Drug Applications (ANDA)
  • Biologics License Applications (BLA)
  • Drug Master Files (DMF)
  • Biologics Master Files (BMF) Emergency Use Authorizations (EUA)
  • Other regulatory submissions

Specific to Biotech, ShareVault includes an integrated eCTD Viewer for fast regulatory review.

Protections for Clinical Trials

Biotech product development usually involves clinical trials. ShareVault’s VDR environment ensures that Patient Health Information (PHI), both stored and shared, is always secure, and meets HIPAA’s strict privacy guidelines.

ShareVault provides the biotech industry with the most advanced document-sharing capabilities and granular access control policies in the business. Using ShareVault, clinical trial organizations and their product development partners can confidently share sensitive patient information and company data without compromising patient privacy security.

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With ShareVault, Biotech can Focus on Outcomes

Biotech development is often a long and arduous process that requires the expertise of product development pros, clinicians, analysts, manufacturing gurus, and many others. ShareVault knows the industry well and we are dedicated to providing a secure and easy-to-use platform for your efforts - so you can focus on the important work you do!

Contact us today for information on a custom solution to your security needs - or check out our Free Trial Demo!

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