Blog  •  August 08, 2023

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Life Sciences Organizations Look to Virtual Data Rooms to Manage Clinical Trial Confidential Data, and More

Life sciences, biotechnology, and pharmaceutical firms are pivotal in advancing medical research and revolutionizing the healthcare industry through innovations, developments, and research. In their pursuit of groundbreaking treatments, cures, and therapies, these firms handle, collaborate on, and regularly need to transmit a wealth of sensitive information — and need to do so securely and efficiently. Consider the confidential data at stake: highly classified intellectual property, proprietary research data, clinical trial results, and personal medical records of patients involved in studies — all of this must be shared with researchers, analysts, stakeholders, academic partners, and regulatory authorities including the FDA.

Safeguarding sensitive information is paramount to ensuring the progress of scientific discovery and the preservation of trust, not to mention mitigating risks and preventing data compromises. To do this necessitates stringent security measures to protect against unauthorized data access and potential misuse, especially since the stakes go far beyond financial implications to ethical and patient privacy considerations.

Keeping highly sensitive information and documentation safe throughout the research and development process requires full-featured virtual data rooms (VDRs), such as DFIN’s Venue, a secure and intuitive virtual data room platform used by organizations to transmit sensitive data and share confidential documents with external parties, streamline collaboration among authorized stakeholders, and meet regulatory compliance.

Venue, built with life sciences organizations in mind, is able to handle:

  • Research and scientific discovery: collaboration to speed the development of medical research
  • Clinical trials: sharing of highly sensitive data with clinicians and stakeholders
  • Licensing: organizing drug and device intellectual property so you are ready for any deal
  • M&A deals: streamlining due diligence for deal-readiness
  • Fundraising: sharing fundraising data such as conceptual data model files, DICOM files, and more

Take Venue user Catalent, for example. Catalent is a global contract development and manufacturing organization that enables partners to optimize the development, launch, and supply of better patient treatments. The organization produces an enormous amount of sensitive data while developing, manufacturing, and supplying products to help people live better and healthier lives. Some data sets must be collaboratively shared with external partners, lenders, underwriters, investors, and regulators, while other data sets must be shared with internal sites, departments, teams, and individuals. Sharing this sensitive data requires a high level of security, which is not possible using typical collaboration tools. An executive of Catalent commented, “Quality is a major component of everything that we do. Venue is incredibly helpful by allowing us to create and refresh always-available virtual data rooms that are immediately ready to support our needs. Our ready-to-use Venue VDRs help us to enforce internal discipline because we know they exist and know their structure and contents. When the time comes, we can move very quickly as a routine part of our business process without having to recreate or start from scratch.”

Palisade Bio is another company that turned to Venue to keep its clinical team on-task during the pandemic. When COVID-19 began shutting down most U.S. workplaces, Palisade Bio was in the middle of a vital Phase 2 clinical trial to test the efficacy of one of its main drugs. Palisade turned to DFIN's Venue to share and manage its clinical trial data. Inge Bear, Chief Development Officer for Palisade Bio, stated, "Working with DFIN’s Venue let us question why we were doing things how we have always done them. Using the platform has certainly opened the eyes of our company and the industry in general. We found a new way to do business that offers efficiency and cost savings and is a long-term solution.”

Read here for more information on how leaders in life sciences leverage Venue as part of their day-to-day business. Read here to learn how organizations in other industries are leveraging virtual data rooms.

The High Stakes of Protecting Clinical Trial Data
Critical research data and clinical trial findings center around extensive studies involving human participants; the resulting data includes medical records, genomic data, and diagnostic information. The secure and ethical transfer of such data is crucial for ensuring the integrity of scientific research, compliance with regulatory standards, and the well-being and privacy of the individuals involved in the studies. With the potential for profound medical breakthroughs hinging on analyzing this sensitive information, robust security measures for data transfer are required.

Besides protecting the privacy of individuals, the intellectual property assets that form the foundation of research and development endeavors are instrumental in driving scientific progress and commercial success. This includes patents for novel therapies, techniques, and genetic discoveries, all fiercely guarded by organizations to maintain a competitive edge and secure exclusive rights to their innovations. Additionally, biotech and pharmaceutical companies often manage confidential business strategies, market insights, and financial data that can significantly impact their market position and investor confidence — especially if they participate in any M&A activity.

Advanced security is required throughout the clinical trial process to ensure the protection of this data and uphold the ethical principles of research. Venue has advanced security embedded at every level, with multi-factor authentication, 256-bit encryption, virus/malware scanning, secure information rights management (IRM) — Venue users can provision permissions of precisely who can see what — and dynamic watermarking. Venue has the highest levels of infrastructure security and meets stringent auditing and reporting compliance requirements, including SOC2 Type II auditing and reporting and ISO/IEC 27001:2013 compliance.

Organizations that rely heavily on research and intellectual property — or regularly manage sensitive information — need secure document sharing with compliance management built in to comply with the multitude of data privacy regulations and streamline processes. Traditionally, sharing confidential information involved physical paperwork, couriers, and complex file-sharing systems, leading to potential delays and data security vulnerabilities. VDRs such as DFIN’s Venue, on the other hand, provide a centralized and cloud-based solution where authorized stakeholders can securely access documents from anywhere in the world, facilitating real-time collaboration and expediting decision-making processes.

Life sciences organizations and others are increasingly turning to virtual data rooms as an invaluable tool to safeguard sensitive information while maintaining agility and efficiency in their operations. And the cherry on the sundae is that DFIN’s Venue recently won the Global InfoSec Award for Publisher’s Choice Virtual Directory Services.

dannie combs

Dannie Combs

Chief Information Security Officer, DFIN

Alex Hooton

Alex Hooton

Vice President, Head of North American Venue Sales, DFIN