[Video] How a Data Room Supports In & Out Licensing of Drugs & DevicesPosted on
Whether you’re a small start-up drug company or part of a big pharma conglomerate, there are many benefits to using a virtual data room. In this quick video, we walk through how a Firmex Virtual Data Room (VDR) can help with M&A due diligence for the in and out licensing of drugs and devices.
The primary use case of a virtual data room is sharing a large number of confidential documents for M&A due diligence. Here’s how it works: Each of your programs gets its own project in the data room. Within that project, you upload your drug’s information, whether it’s in development, undergoing clinical trials, or already on the market.
Group-based permissions mean you set up a group of users — in this case, your potential buyers — once, and any users you add to that group inherit the group’s permissions. You determine each group’s access. Which information they get to see, and which information remains hidden. Your IP is yours, and Firmex helps you keep it that way with advanced document protection. Apply a watermark, disable printing, saving and sharing, and if saving is allowed, expire access to the documents, even if they’ve been downloaded to a user’s computer.
Once you’re ready to open up your project to buyers and send out invitations to the data room, you can double check your user permission settings using tools like “View As” and folder access reports. Reports let you track and monitor every action that’s performed in your project. That means you can see at a glance who’s logged in, when they’ve logged in, and what information they’ve seen.
All communication relating to the deal is kept in the data room using a Q&A module. You’re notified as soon as a question is asked. You can then answer the question directly, or assign it to one of your experts. You’ll avoid bottlenecks by never losing track of questions again.
Outside of due diligence, our pharma clients also use their data rooms to support many other critical areas of their business where confidential information needs to be safely shared.
Collaboration with CROs
In pharma, your intellectual property is everything. Any time you need to share confidential data outside the walls of your business, the stakes are high. Whenever your IP has to leave the company firewall for external lab testing or clinical trials, keeping track of files and your CRO communications is critical. This is where a virtual data room comes in.
Let’s say you have a drug recipe ready for testing: You simply upload your drug information to a project in the data room and set up your external lab to be able to view the files. You can set up document protection so that once the lab’s tests are over, you can take back or expire those sensitive documents.
When the testing is complete, the lab technicians simply upload their findings and reports to the data room. If they don’t want to log in, they can email the documents directly to the data room. Everything is centralized and remains safe in the same highly secure and compliant data centers as major corporations and financial institutions use.
Flash forward a few months, and now your drug is ready for clinical trials. Let’s say the trials will be run in two clinics, one in North America and the other in Europe. When the clinicians complete their trials, they deliver the results to the data room. Next, you need to hire an outside contractor to produce a clinical trial report, so you share your findings with yet another external party.
A Firmex virtual data room ensures that you only share the necessary information with the right people — and that you do it with the utmost security and control. The “View As” tool shows you exactly what each user sees, so you can quickly confirm permissions to make sure that your contractor has access to only the documents she needs. Firmex usage reports show you when she’s logged in and what documents she’s accessed.
Built-in Q&A facilitates communication between clinicians, researchers and your contractor. Finally, when the clinical trial report is complete, you are notified via email that it’s been uploaded. Any changes that need to be made to the report will be automatically detected as new versions within the data room.
Regulatory & Compliance Audits
Another fact of life in the pharma industry is audits. Throughout a drug’s lifespan, a pharma company audits others and gets audited. A virtual data room brings speed, accuracy and transparency to the auditing process.
When you’re considering working with a CRO, you ask a lab for their GLPs and GMPs. The lab uploads those certificates and any supporting documentation.
When you receive an FDA process inspection checklist, you import that checklist into your virtual data room. You can now begin preparing for the audit in a way that’s process driven. Some line items require a simple “yes, no, or not applicable,” while other items require supporting documentation. At any time, you can run an audit snapshot report that gives your team and the auditors a clear understanding of which items have been audited, and which still remain.
Your company spends years on drug discovery and development, testing, clinical trials and approvals. Throughout the lifecycle of a drug, a virtual data room can help you safely and securely manage and share your IP with partners, investors and buyers. If you want to dig a little deeper into how a Firmex virtual data room can help you, check out our video on pharma licensing and then have a read of how one of our pharmaceutical clients, Pediapharm, is benefiting from using a Firmex virtual data room.