Counterpoint AI
Regulated operations that move at the rate of change
Counterpoint dramatically reduces the operational overhead of constant change — from protocol amendments to cross-study execution — so CROs, CDMOs, and biotech sponsors
operate with lower friction
respond in hours instead of weeks
and grow without compliance becoming the constraint
The Control System for Regulated Operations
Learn how Counterpoint continuously maintains operational readiness in the face of change
A governed system of action for regulated operations
Your rules are the foundationCounterpoint transforms your SOPs, protocols, and regulatory frameworks into a structured knowledge graph that automatically enforces and implements your governance logic. All outputs produced by the platform are constrained by the graph, traceable to the underlying requirements, and scoped to the roles they apply to.
Your operations update automaticallyAs products, procedures, and requirements evolve, Counterpoint continuously determines the change scope and generates content, training, assessments and scoring for the specific roles that are affected. The record of who is authorized to do what stays current, without manual cross-system reconciliation.
Your experts own every decisionNo AI-generated output enters your system of record without review and approval by your subject matter experts and quality team using a structured, efficient interface.
Inspection-readiness—on demand, at scaleCounterpoint continuously maintains complete operational lineage — from regulatory requirement to role to content to training to each person's authorization to perform regulated work. When an inspection arrives, the system generates a complete evidence package from records it has been maintaining all along.
The result
Lower cost and operational friction
Faster program adoption
Stronger compliance outcomes
The confidence to expand into new programs, sites, and markets without compliance becoming the constraint.
Compliance that keeps pace with your growth
A CRO managing multiple active trials operates under distinct documentation, training, and audit requirements for each sponsor, with overlapping personnel across concurrent programs. Counterpoint provides a unified governance layer across sponsor contexts while each sponsor's protocols, training materials, and regulatory commitments remain fully isolated — so each new relationship adds revenue, not risk.
CDMOs face qualification and documentation demands that compound with each new program, sponsor, and technology transfer stage, making manual reconciliation increasingly untenable. Counterpoint provides the infrastructure to qualify personnel, maintain operational lineage, and demonstrate current competency at the pace development-stage manufacturing demands.
As sponsor programs progress from Phase I through Phase III and into commercialization, the governance surface grows in proportion: more sites, more personnel, more vendors. Counterpoint enables you to fulfill your ICH E6(R3) obligations, providing a continuously governed record of who is qualified for what, across your portfolio.
Removing compliance as a constraint
Beyond compliance tracking
Most compliance tools were built to track events: Was a document approved? Was a training assigned? Was a course completed?Counterpoint was built to maintain the entire operational state and continuously generate the content, training, and qualification evidence required to close the gaps.Tracking events is record-keeping. Tracking operational state is governance. Maintaining operational state is Counterpoint.
From passive record-keeping to active operational readiness
AI that's compliant by constructionCounterpoint combines generative AI with a locked deterministic rules layer. Generative AI produces content at the speed your operations demand, while rules ensure every output is source-bound, role-specific, and version-aware — so what gets generated is compliant and ready to use.It is not a general AI assistant that may or may not behave correctly inside a regulated process. It is not an AI add-on to your LMS, your QMS, or your document management system.Counterpoint is a new class of applied AI infrastructure — purpose-built for regulated work, with compliance logic built into the architecture, not applied after the fact.
The new core architecture for regulated operations
About us
The most impactful systems are built by people who understand the problem and know how to scale — especially in complex, standards-driven and regulated environments.We’ve spent our careers doing exactly that.
Jonathan Hevenstone • Co-founder and CEO
Go-to-market and operations leader with 20 years’ experience scaling revenue and building global commercial organizations in complex, standards-driven, and highly structured industries at the intersection of content, data, and platform systems. Translates domain complexity into scalable, production-grade platforms deployed across global digital channels.Previously served as Chief Revenue Officer at Memorang and Boclips, SVP Sales & Marketing at Atypon (acquired by Wiley), and EVP Business Development at Paris-based Jouve.
Rhett Smith • Co-founder and CTO
Technology leader with deep expertise in large-scale platform architecture, AI-driven product development, and regulated software systems for complex, high-stakes environments. Over two decades of experience building enterprise platforms from startup through acquisition, IPO, and public-company scale across BioTech, LegalTech, and EdTech.Previously served as EVP, Head of Engineering at 2U / edX, Chief Architect at McGraw-Hill, and CTO at Memorang. Has led the design and implementation of FDA-regulated clinical trial and manufacturing systems compliant with 21 CFR Part 11 and built products used by over 100 million users worldwide
Get in touch to learn more
OUR OPERATING PRINCIPLESSecure & Private
• Customer data is never used to train external or shared models
• All customer data is logically isolated and securely handledAuditable by default
• Full logs of inputs, outputs, and transformations
• Reproducible and traceable runs for verification and complianceHuman in the loop by design
• Humans make decisions, agents inform them
• Review and approval workflows with support for 21 CFR Part 11 electronic signatures
Compliance for a new era of continuous change
Current compliance systems were built to prove that process was followed: a document was approved, a training was assigned, a course was completed. That was the right answer for a long time.The world these systems were designed for has shifted.FDA warning letters jumped 50% year over year in 2025 — and regulators now expect systemic remediation, not fixes to individual findings. For CDMOs, the remediation costs alone from a single warning letter can reach 15% of the affected business unit’s revenue. Meanwhile, CROs, CDMOs, and sponsors are managing compliance obligations across more programs, sites, and vendor relationships than ever before. The compliance infrastructure built for a simpler era wasn't designed for this.Counterpoint is a system of governed action built for this new world. The platform determines what actions are required under governed change, generates the content and learning needed to execute those actions, and produces the evidence to prove they were done correctly.