Secure Document Sharing and
Collaboration for Diagnostic Equipment Development

The secure way to
manage your IP assets

The diagnostic equipment market is expected to see annual growth rates of around 5.5% over the next 5 years.

Factors driving market growth include:

  • Rising prevalence of chronic diseases, including cancer, diabetes, hypertension, stroke, heart disease, respiratory diseases, arthritis, and obesity
  • Aging populations, with the population of those over 65 projected to double by 2050

Technology advances:

  • Accelerated use of genomic data, aided by artificial intelligence analysis
  • Wearables, combined with advanced software for remote patient monitoring
  • The advent of IoT and 5G connectivity, which enable better communications and remote data collection from medical devices and diagnostic equipment.

As technology has advanced, so has the threat of hackers accessing confidential information. The FDA now holds medical equipment manufacturers accountable for security-related problems, making security, communications and collaboration among manufacturers, healthcare providers, and suppliers a front-burner priority.

Security risks are particularly acute during the product development process. Savvy hackers can target work-in-progress files and data and images used in developing AI machine learning to implant malware.

That’s where ShareVault comes in. ShareVault’s Virtual Data Room is a cloud platform for secure storage and sharing of critical documents during the development process. ShareVault also has solutions for real-time co-authoring and secure distribution of work-in-process documents.

THE ULTIMATE DATA ROOM FOR LIFE SCIENCES

ShareVault’s Data Room allows efficient organization with drag-and-drop filing tools and ultra-fast search. Throughout the process, files and collaborations are protected by the industry’s highest levels of security. ShareVault is the vendor of choice for Diagnostic Equipment development and other applications:

To ensure a quality outcome, ShareVault provides advanced document and communication security for internal teams, collaborators, management, and outside parties like investors and regulatory agencies.

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9 out of 10 Top Pharma Companies
Use ShareVault. See if you should too.

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 Diagnostic Products Development

There is no better 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 — Hot to avoid predictable Failure for Early-Stage Life Science Companies

Life science founders are technical experts in their fields, but they frequently fail to understand the needs of the stakeholders who drive the path to market. This is preventable.

In this webinar, Dr. Lucia Mokres breaks down the six major stakeholder categories relevant to most life science companies and shares key strategies for closing the knowledge gap.



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 Officer

"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

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