Superior Data Room Platform for Drug Development

Secure document sharing for
API Biologics development

The Active Product Ingredient (API) market is booming, with a current global value of $178 billion and representing approximately 10% of the global pharma market.

Many factors are driving sustained market growth around 6% CAGR, including

  • Rising prevalence of chronic medical conditions, accelerated by lifestyle changes
  • Aging populations, with the number over 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, product development, and initial production.

This leads to a tremendous number of highly sensitive documents being shared and collaborated on between parties. These documents need to be protected.

Security threats and pressures continue to rise.

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.

API development is a collaborative process with large data files and extensive documentation over a long timeline. They must protect sensitive and compliance materials from the growing threat of hackers or face potentially heavy fines on top of costly ransom demands or worse loss of intellectual property and competitive information.

ShareVault provides a secure platform for API biologics development.

ShareVault is perfect for protecting the vast quantities of files involved and making them accessible under strict security controls to whomever you grant limited access.

Now you can safely share critical reports and work-in-process documents during the development process with peers, and partners. The ShareVault Virtual Deal Room (VDR) not only protects in-house development, but also 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.

We facilitate document sharing and collaboration through all phases of development

Development Finalization Production
Collaboration between labs, CROs, remote technicians and experts Collaboration between Pharma company, lab and regulatory experts Collaboration between Pharma company, suppliers and distributors

Recognized Leader
in Life Sciences

ShareVault is the leading virtual data room provider to the 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

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:

  • Ultra-secure Virtual Data Room (VDR) for collaboration and archiving and sharing confidential files under the strictest permissions and policies, which govern access from in-house users as well as clinical trial teams and third parties in remote locations.
  • ShareVault is the only data room provider that has developed a special features of particular interest to Life Sciences companies. These include Inter-document hyperlinking and integrated eCTD Viewer for fast review of regulatory submissions.

Secure Document Collaboration:

  • Secure Document Sharing for work-in-progress documents that are distributed in their native format to contributors and edited locally.
  • CollabLoop for secure centralized word-compatible document editing, redlining and redacting in the cloud - like Google Docs, only much more secure.

Outstanding Support:

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.



DEEP EXPERIENCE IN DIAGNOSTIC PRODUCT DEVELOPMENT

"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 permissioning 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