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Behind the Investment: BTR – Computer System Validation, Automated

Julian Marcu | February 11, 2022| 1 min. read

Today, enterprise life sciences companies spend roughly 15% of their IT budgets on Computer System Validation (“CSV”), which equates to tens of millions of dollars annually:

-    “Our peers are spending double-digit millions on CSV as well. Everyone has to be compliant with the FDA guidelines, and without that they cannot sustain” – $100B+ Public Pharma Company

This spend is largely driven by FDA regulations (FDA Title 21 CFR 11, 211, 820), which mandate that any systems touching sensitive life sciences data are doing exactly what they’re designed to do in a consistent and reproducible manner while maintaining data integrity. To get any medication to market, there is a long, arduous process, and CSV ultimately ensures that the software enabling any piece of that process is operating correctly so as not to negatively impact the design, manufacturing, efficacy, or safety of that medication. As a result, if CSV is not executed & documented correctly, and performed every time any sensitive system undergoes a software update, the FDA can prevent any medication from reaching commercializing.

Historically, this CSV process was extremely complex, mundane, and repetitive with various internal and external (i.e. consultant) stakeholders testing, reviewing, and collaborating manually via email and physical pen-and-paper. As a result, CSV devolved into a heavily cumbersome, expensive, and slow-moving, yet absolutely necessary, process for any life sciences company and software vendor selling into the life sciences industry. Additionally, the CSV pain-point is only becoming further exacerbated by life sciences cloud adoption, the rise in CI/CD (resulting in increasingly frequent and mandatory software updates), and the aforementioned FDA regulatory & compliance tailwinds. Ultimately, these dynamics created a massive market opportunity ripe for disruption, and this is where BTR takes center stage. 

-    “The paperwork is bloody daunting… it used to take over 400 hours for each validation pack on a release. The problem is that without BTR, we are updating and maintaining word documents manually, pushing out to DocuSign and then scanning on the other side so a human can pen-and-ink all this.” – Industry Leading Life Sciences Software Vendor

BTR provides a digital CSV platform (“Res_Q”) to automate the entire CSV process end-to-end, spanning testing, validating, and qualifying of any sensitive systems. In doing so, BTR unlocks an unprecedented level of visibility, collaboration, compliance, and auditability for all of its customers and software vendor channel partners; by automating CSV via BTR, software vendors such as Veeva, Nuvolo, Benchling, Docusign, SAP, and others reduce the time-to-value for their own products, driving a win-win-win outcome. 

Founded in 2015, originally as a services organization, and pivoting in 2019 to productize its expertise and to start developing the Res_Q software platform, BTR is now experiencing rapid adoption from the market by growing 10x year-over-year in 2021 and boasting several public life sciences customers.

  • “Companies need BTR because the FDA will ask for Val-Packs during audit. The FDA requires that companies are using a validated environment…If we didn’t use BTR, the alternative was to repurpose Jira or ServiceNow.” – Industry Leading Life Sciences Software Vendor
  • “BTR is mission-critical. If they aren’t there, it’d be hard to find another vendor that can do what we need.” – Public Life Sciences Company
  • “We did some testing and mock audits and realized our change control system in Jira got beat up. When comparing Jira vs BTR, BTR was leagues ahead. We plan on shifting all of our change management to Res Q.” – Public Life Sciences Company

As for the genesis of the partnership between Insight & BTR, the company was first brought to our attention by another Boston-based member of the Insight Partners family – Fairmarkit. Fairmarkit had told us about an early-but-revolutionary life sciences software vendor accompanied by an elite management team with the vertical-specific expertise to execute; we quickly arranged an intro call with the CEO, Bryan Ennis, in January 2021 and immediately knew something special was brewing. Come November 2021, BTR had commercialized their SaaS platform rapidly and quickly scaled the team to ~50 employees, putting them in the sweet spot for us to partner with BTR to further accelerate their growth and take the business to the next level!

We could not be more thrilled to be leading BTR’s $15M Series A with participation from existing investors LRV Health, New Stack, and Jumpstart, and I personally could not be more proud to serve as Board Director on behalf of Insight Partners. Now, post-investment we remain eager to double down on BTR’s rapid commercialization as they continue to shape the future of automated Computer System Validation – this is just the beginning!