Scaling Legal Capacity in a Highly Regulated Industry 

Accelerating contract review across research, clinical, and supplier agreements.

The Challenge: High Volume and Regulatory Complexity 

For a leading biotechnology company advancing breakthrough therapies, contract management had become a mission-critical function. Each agreement whether a clinical trial agreement (CTA), material transfer agreement (MTA), research collaboration, or supplier contract had to meet strict regulatory, compliance, and data-protection requirements across multiple jurisdictions. 

The legal department faced mounting pressure to keep pace with the company’s rapid growth and global research footprint. Each new program introduced dozens of new contracts, each requiring line-by-line review for regulatory language, data privacy terms, and intellectual property protections. 

The result was an overloaded legal team, inconsistent language across global templates, and extended cycle times that slowed clinical and commercial operations. 

The company needed a way to handle rising volume and complexity without adding headcount – while maintaining absolute accuracy and compliance. 

The Solution: Intelligent Contract Review that Keeps Pace with Science 

The company partnered with BlackBoiler to automate the review of its research, vendor, and regulatory agreements. Working alongside the firm’s in-house legal and compliance teams, BlackBoiler trained its AI using: 

  • Historical redlines from past CTAs, MTAs, and vendor agreements 
  • Internal playbooks governing clinical and regulatory terms 
  • Jurisdiction-specific clause libraries for data and IP protection 

Now, when new contracts arrive from CROs, research partners, or suppliers, BlackBoiler automatically redlines them in “Track Changes” based on the company’s standards. The system flags high-risk deviations, proposes preferred language, and applies the correct regulatory clauses for each jurisdiction. 

With every review, our proprietary AI learns from the company’s feedback, continuously refining its precision and ensuring consistent application of complex requirements across global teams. 

Results: Consistency, Compliance, and Speed 

In its first year using BlackBoiler, the company achieved measurable improvements in both efficiency and control, including a 60% reduction in contract cycle time across research and supplier agreements and a 75% acceptance rate of AI-suggested edits by reviewers. The faster turnaround on regulatory-sensitive documents also enabled projects to launch sooner, helping the organization keep pace with scientific and operational demands. 

Legal teams now focus on high-value analysis and negotiation, while BlackBoiler handles the repetitive markup. This balance allows the company to scale its operations while maintaining the precision required in a regulated industry. 

“BlackBoiler gives us consistency across every region and every contract type. It’s like having a regulatory specialist built into every review.” 

— Deputy General Counsel, Global Biotechnology Company 

The Outcome: Enabling Growth Through Compliance-Driven Automation 

With BlackBoiler, our client can move faster without compromising compliance. Contracts are reviewed in hours instead of days, teams operate from a single source of truth, and legal resources are refocused on advancing innovation rather than managing administrative workload. 

BlackBoiler has become an essential partner in the company’s digital transformation, helping ensure that regulatory rigor and operational speed can coexist as the business scales globally.  

Where BlackBoiler Helps in Biotechnology

  • Clinical Trial Agreements (CTAs): Ensures required patient-data, IP, and liability language is consistently applied. 
  • Material Transfer Agreements (MTAs): Standardizes provisions around ownership, confidentiality, and research use. 
  • Research Collaborations & Licensing: Flags deviations in IP and publication clauses. 
  • Supplier & Manufacturing Contracts: Maintains alignment with GMP, data security, and compliance standards.

AT A GLANCE:
KEY RESULTS

↓60%
Contract Cycle Time

75%
Edit Acceptance Rate

↓Significantly
Legal Review Workload

Improved Across Regions 
Compliance Consistency

Accelerated
Time to Project Launch

About Blackboiler

BlackBoiler is the world’s first AI-powered contract redlining software. Built to automate the repetitive and empower the strategic, our proprietary AI reviews and redlines contracts in “Track Changes” using your playbook and historical data, learning and adapting with every use. 

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