Secure Document Sharing for API Biologics Development

ShareVault: A Superior Virtual Data Room Platform for
Drug Development

The Active Product Ingredient (API) market is booming. With a current global value of almost $210 billion, APIs represent approximately 10% of the global pharma market.

Many factors continue to drive this market growth around 6% CAGR:

  • Rising prevalence of chronic medical conditions, accelerated by lifestyle changes
  • Aging populations, with the population over the age of 65 projected to double by 2050
  • Patent expirations for branded APIs, creating high growth in generics
  • Accelerated use of genomic data, aided by artificial intelligence analysis

API biologics development is sometimes outsourced to Contract Development and Manufacturing Companies (CDMOs). CDMOs are “one-stop shops” that provide a single source for lab development and product production.

Biologics Collaborations Create Security Vulnerabilities

API development is a collaborative process involving large data files and extensive documentation, shared among labs, CROs, analysts, manufacturers, and other parties. These documents contain confidential and proprietary information that needs to be protected.

The cybercrime community now employs state-of-the-art tools for hacking, and API Biologics development is a prime target. Archived and work-in-progress documents can be attacked by AI-enhanced hacking algorithms. A hack of even a single document can lead to the insertion of malware into the development team’s collaborative network.

The consequences of a hack can be ruinous: ransom demands, loss of intellectual property and competitive information, litigation, and fines - API biologics development and production, like all pharmaceuticals, must adhere to Federal Drug Administration (FDA) and Health Insurance Portability and Accountability Act (HIPAA) regulatory guidelines that protect patient privacy. The FDA now holds manufacturers accountable for security-related problems.

A Virtual Data Room Provides Secure Document Sharing

A virtual data room (VDR) provides a secure environment for storing confidential documents during API Biologics development. All development parties can share confidential information with ease and without compromising security, protecting against cybercrime and leaks to the competition.

Secure Document Sharing in Biologics

ShareVault Provides a Secure Platform for API Biologics Development

A ShareVault virtual data room is perfect for protecting the vast quantities of files involved in API Biologics development. ShareVault makes them accessible under strict security controls to whomever you grant limited access.

During the development process, parties can safely share critical reports and work-in-process documents with peers and partners. The ShareVault VDR not only protects in-house development but also safeguards collaborations with third parties anywhere around the world.

When the time is right, the development team can invite regulators, investors, and partners to view reports and presentations in an ultra-secure environment. ShareVault’s activity monitor allows the team to provide a detailed report for audits.

ShareVault offers free demos for manufacturers and providers who are interested in seeing firsthand how this security solution could work for them.

Try it out for your API Biologics Development

Collaboration Through All Phases of Development

Development Finalization Production
Collaboration among labs, CROs, remote technicians, and industry experts Collaboration among Pharma companies, laboratories, and regulatory experts Collaboration among Pharma companies, suppliers, and distributors

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Recognized Leader
in Life Sciences

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

ShareVault Data Rooms are 21 CFR part 11 Compliant. Learn why this is so important for clinical trials.

Field-Tested for API Biologics Development

ShareVault is the platform of choice for secure document sharing in API Biologics development and other Life Science applications, including:

ShareVault is the ideal solution for sharing confidential documents with partners, regulatory advisors, CROs, CMOs, and other third parties. When regulatory submissions are required, ShareVault’s enterprise-grade solution 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), and other regulatory submissions.

Why ShareVault

Secure Document Sharing

  • The ultra-secure Virtual Data Room (VDR) is ideal for archiving and sharing confidential files. Document sharing is subject to strict permissions and policies that govern access by in-house users as well as clinical trial teams and third parties in remote locations.
  • ShareVault is the only data room provider that offers features specifically for Life Sciences, including inter-document hyperlinking and an integrated eCTD viewer to quickly review regulatory submissions.

Secure Document Collaboration

  • Secure Document Sharing for documents and data files
  • ShareVault’s optional Dynamic Native File Protection (DNFP) protects work-in-progress documents during the editing and sharing process
  • ShareVault’s CollabLoop is task-management software for editing and redlining critical documents in preparation for submission - as easy to use as Google Docs but much more secure

Outstanding Support

  • ShareVault’s award-winning support team is on-call 24/7
  • Your support team is led by a ShareVault manager with Life Sciences experience
  • ShareVault offers a 21 CFR 11 Compliance Validation Package

Webinar — Quality by Design – Remote Monitoring and EFM Integration

Janice del Rosario, TMF Consultant at LMK Clinical Research Consulting, and Mike Liccardo, VP of Corporate Development & CFO at ShareVault, explore how to implement a Quality by Design approach to remote site monitoring by leveraging eSystems while remaining compliant.

Hear What ShareVault Life Sciences Clients Say

"Uploading documents to ShareVault is easy and fast and the organizational structure is straightforward and dynamic to our needs. Being able to designate who can access specific documents and then knowing what is being reviewed is also important. It is also very easy to use search terms to find specific documents, which also saves time."

— Eli Thomssen, Armune BioScience, Inc, Chief Business Office

"We chose ShareVault for its ease of use and rich feature set as well as its flexibility for providing secure access to documents in a variety of situations. In our case, we needed the ability to easily manage multiple levels of access. We also appreciate how easy and intuitive ShareVault is to use. Our administrators were publishing in the system and managing documents in a matter of minutes."

— Renny Clark, Gentuity LLC, former CFO of CardioFocus

"The tracking metrics were great, allowing us on a real-time basis to see who had been accessing each document and for how long they were logged in. I was very happy with the selection of ShareVault and felt that it contributed to the ability to complete our process on a timely basis."

— Mark Fischer-Colbrie, ADEZA, former CFO

"ShareVault gives us the ability to stage the sharing of intellectual property securely, explore partnerships with a greater number of organizations and share different tiers of information as relationships evolve."

— Jill Jarecki, PhD, Chief Scientific Officer, CURE SMA

"With ShareVault, we're prepared for due diligence far ahead of time. Our data is organized, we can grant customized access to potential partners and our information is organized, safe, and easy to access."

— Yoke van Oosterhout, PhD, Chief Executive Officer, Xenikos

"After struggling with other systems, we moved to ShareVault and have found that inviting users and tailoring the permissions of documents couldn’t be simpler. We also have every confidence that our sensitive materials are completely secure. When situations change, it’s a snap to change or revoke access."

— Dan Schmitt, Actuate Therapeutics, President & CEO

"ShareVault is more intuitive and user-friendly than other platforms and the technology performs well over a wide range of operating systems, browsers, and security barriers. We’ve also found it invaluable to be able to monitor data room activity (down to the page level) of individual users, informing us on the interest level of our clients and allowing us to have constructive follow-up discussions."

— Jonas Ekblom, Promore Pharma, CEO