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Data Room for Biotech Firms: Best Practices - The Complete Guide

Kison Patel
Kison Patel

Kison Patel is the Founder and CEO of DealRoom, a Chicago-based diligence management software that uses Agile principles to innovate and modernize the finance industry. As a former M&A advisor with over a decade of experience, Kison developed DealRoom after seeing first hand a number of deep-seated, industry-wide structural issues and inefficiencies.

CEO and Founder of M&A Science and FirmRoom

The main purpose of data rooms amongst biotechnology firms is to provide storage space, protect against data breaches, and allow for secure data sharing.

Virtual data rooms are commonly used in M&A, as keeping your data centralized is essential in order to stay on top of your diligence when sharing important documents.

But the use of data rooms is not limited to M&A; FirmRoom plays host to a wide spectrum of biotechnology and pharmaceutical deals, transactions, fundraisings, partnerships, and much more.

What is Biotechnology?

Biotechnology involves the use of biological processes for industrial purposes with the use of new and innovative technologies.

Playing a host to a wide spectrum of biotechnology deal and transaction activities, FirmRoom has had the chance to gather valuable insights into the processes.

We learned that the purposes of biotechnologies include improvement of the environment, such as renewable energy sources; improvement of life, such as medications and health products; and treatment and prevention of diseases.

In other words, it is the technology ensuring that human needs are met in the most efficient and effective way possible.

data room biotech

Why do Biotechnology, Pharma or Healthcare Firms need Data Rooms?

With the broad definition that encompasses biotechnology comes the need for more advanced technology, especially in the form of data organization and management.

While traditionally the sciences have been slow to move into the use of new technology for data management, at FirmRoom, we have seen that biotech, pharma, and healthcare firms have been among the first to adopt it, likely due to their need for technology to function as designed.  

The best part?

FirmRoom's vast experience alongside biotech firms led us to develop powerful functionality you won't find anywhere else.

Here is what to expect:

Data Security

Data rooms are useful for biotechnology firms due to their numerous benefits. The first of these, as previously discussed, is data security, our top priority here at FirmRoom.

DATA SEcurity firmroom

When working with clinical trials, it is important to maintain confidentiality to ensure that these trials are viable.

Storing trial data in a data room rather than simply saving them on a computer connected to a local network ensures that this information will not be affected in the case of a data breach or similar circumstances.

At FirmRoom, we offer features such as SOC 2 Certification, ISO 27001 Certification, SSAE 16 Certification, and Data Center Security.

Effective File Management

File management is much more effective and organized with the use of data rooms, and more simple and convenient to use and learn than other software may be.

At FirmRoom, we have seen that the use of the task management system to assign tasks to users inside the data room ensures ease and accessibility of use by any level of professional, from clinical researcher to CEO.

More Efficient Data Sharing

Virtual data rooms also allow for data sharing without the need for physical data rooms, saving time and money by allowing information sharing while ensuring that it is only shared with those who should have access to it.

This improves collaboration and allows all those involved to contribute to the process securely with easy remote access to data and data sharing on a real-time basis.

Data rooms eliminate the need to make in person trips to share data as well as eliminate the variables involved with the mail process.

Monitoring Deal Progress

Monitoring the progress of a deal or project is made significantly more straightforward with the use of a data room. Progress can be tracked and the workflow can be managed by using a unified dashboard that all those involved, no matter from what location, can see.

Advanced analytics

FirmRoom offers advanced analytics that track the time spent on documents and how many users are viewing it, thus eliminating any communication errors or difficulties that may arise.

firmroom advanced analytics

This ultimately allows for rapid identification of errors before they cause serious issues that may set the project back weeks, if not months.

How do Biotech Firms Leverage Data Rooms?

Data Sharing in Clinical Trials

Biotech firms leverage these data rooms in a variety of manners, but one of the most impactful is that of data sharing in clinical trials.

Data rooms address the main challenges of organization and confidentiality that comes along with volunteer participants and a large volume of researchers, potentially at different locations, that are involved and need access to the information.

With the use of a data room, biotechnology firms can share and upload files at a high volume.

They can also track research communications at every stage, and communicate within their team more effectively. If a question arises, it can be easily asked, directed, and answered in a timely manner.

Easy Smartphone Access

Additionally, FirmRoom offers mobile device access to work with secured documents anywhere from the lab to the other side of the world and allows for an advanced text search for streamlined access to find keywords and phrases without scrolling through each document.

Above all, data rooms centralize the data for easy and secure access by all involved.

Provision of Safety Data

In our findings at FirmRoom, we have seen that the focus of biotechnology firms is on developing pharmaceutical drugs for the treatment of diseases and illnesses.

This has been brought to the public attention during the pandemic, as the vaccine development process and clinical trials were broadcast to a large audience. Along with this comes the need to identify side effects and safety data.

As the FDA has tightened approval standards and regulations, biotechnology firms have been asked to provide more specific safety data with their first presentation of findings. This leads to more extensive documentation which needs to be verified by more people involved.

With the use of a data room, this documentation can be shared online, and the process of expert and FDA approval becomes more efficient. Document linking, as offered by FirmRoom, is useful in this process to link necessary documents for FDA approval together and share with authorized users outside of the firm itself.

Lower Operation Costs

Biotechnology firms often operate on a limited budget; the use of virtual data rooms, as opposed to physical data rooms, lowers the cost of operation without altering the ease of operation and the availability of data sharing.

As an example, FirmRoom charges flat rates instead of charging per page, helping biotechnology firms who are operating on a tight budget.

operating costs firmroom

Streamlined Acquisition Process

Further, as is discussed often in the fields of finance and M&A, acquisitions are often made by larger biotechnology firms of smaller, privately held biotechnology firms who have developed or have shown the potential to develop beneficial pharmaceutical interventions or technologies.

The acquisition process can be streamlined by data rooms with secure communication, and the sharing of data in virtual data rooms ensures that both the firm being acquired and the firm doing the acquiring are fully up to speed on the activities of the other and have all of the necessary information for a smooth transition.

Other Perks

Other uses of data rooms in biotech firms include raising funds for clinical trials, obtaining IP licensure, managing that IP licensure, and holding the actual clinical trials.

All of these are made possible by the secure data sharing in data rooms, and streamlined by the granular access feature at FirmRoom, controlling who is able to view or edit a document based on their role at the firm.

What Should You Include in Your Data Room?

While every virtual data room looks a bit different and can be organized based on individual preference, there are a few key components that we at FirmRoom have found to be important to include for all biotechnology firms.

Additionally, FirmRoom's users have access to a complete biotechnology due diligence checklist & playbook.

Start a free trial today and grab a copy for yourself!

1. Corporate Overview

A corporate overview folder may contain information on the firm and its focus, as well as provide details on the teams, advisory boards, and corporate structure.

This is a great place, especially in a time of acquisition, to gather the necessary information about both firms for a smooth transition and also to find the information on who to reach out to if any scenario requiring intervention were to arise.

2. Investment Overview

An investment overview folder should contain information on each level of the diligence process, and can be accessibility staged so that only those who have met the confidentiality requirements for each level are able to access it.

This ensures security as well as ease of access to information.

3. Commercial Strategy

A commercial strategy folder could be included, containing detailed information about the commercial strategy of the firm, including market research, competitive analysis, and commercial forecasts.

This is useful on a corporate level and also useful in the time of acquisitions.

4. Preclinical Program

A preclinical program folder should be included, encompassing information about completed studies, ongoing studies, and planned studies.

This is one of the most important, as it includes the information and data that is the focus of the firm as a whole.

Descriptions of each study should be included with timing and status, as well as completed reports of all studies and any published manuscripts.

5. Clinical Program

Going along with the preclinical program folder is the clinical program folder.

This should include a program interview and completed studies, as well as much of the same information with the descriptions, timing, and status as the pre-clinical program folder.

The difference lies in that the pre-clinical program folder outlines folders that have not yet been approved for a clinical trial but are progressing in that direction, while the clinical trial folder includes studies that have met those requirements and are at that stage.

6. Regulatory Requirements

A regulatory requirements folder should also be included for reference at each stage of the clinical trial.

This should include the investigator’s brochure, the IND application, a record of any conversations that may have taken place regarding regulations, and an archive of historically relevant regulatory documents.

This helps to ensure that all those involved have access to the regulations that will determine whether or not a study is viable for use.

7. Intellectual Property

A folder should be included for intellectual property rights, including patent estate, granted patents, pending patents, and any other legal documents.

8. Manufacturing

A manufacturing folder can be used for facility overview, contracts, process and process validation data, policies and procedures, inspection documentation, and certificates; this serves as a form of due diligence and proves the integrity of not only the clinical data obtained but the firm itself.

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