Trusted AI for Regulated Life Sciences
AI enabled clinical development
At WaterworksAI, we specialize in providing cutting-edge AI enabled clinical development and research.
Accelerate adoption with transparent, compliant, audit-ready AI systems.
SERVICES
Discover our AI enabled clinical development solutions
Our AI solutions in pharmaceutical processes help streamline protocol writing and accelerate drug development.
Self-Service Governance
Fast, actionable, audit-ready resources designed for teams that want to implement governance quickly without waiting for a consulting engagement.
- Policy Pack
- Governance Framework Pack
- Regulatory Readiness Pack
- Validation & Monitoring Pack
Light Advisory
Light advisory delivers focused, short-duration expert support to help teams implement governance packs, complete assessments, refine documentation, and align with regulatory expectations. This service is ideal for organizations that want targeted input without committing to a full consulting engagement.
- Intake form review
- Risk classification support
- Policy customization
- Validation plan review
Full Governance Consulting
- Complete governance program design
- Validation frameworks
- Lifecycle monitoring setup
- Regulatory alignment (EU AI Act, FDA, GxP AI, etc.)
Service Benefits
We close governance gaps that slow AI scaling by adding traceability, consistency, and controlled workflows.
Problem: AI outputs you can’t explain or defend
How we do it:
- Provide full traceability for every AI-generated sentence (source, prompt, parameters, and edits)
- Maintain an automatic version history with human-in-the-loop rationale capture
- Offer alignment and consistency scoring that flags unclear or unsupported content
- Generate audit-ready documentation for governance, compliance, and QA teams
Outcome: You can show exactly how the output was created – essential for governance, audits, and regulatory reviews.
Problem: Lack of documentation for compliance, oversight, and audits
How we do it:
- Auto-generate documentation packages suitable for governance review
- Track data lineage and provenance for all AI inputs and outputs
- Maintain model-usage logs to support accountability and post-market monitoring
- Capture human review decisions, approvals, and justifications
Outcome: You meet governance expectations for transparency, oversight, and accountability with minimal effort.
Our governance and validation packages combine domain-specific AI controls, lifecycle frameworks, and expert oversight to strengthen decision quality, reduce compliance risk, and accelerate safe, responsible adoption across clinical and regulatory operations.
AI solutions in pharmaceutical development
Pharma Solutions: Transforming Pharmaceutical Development with AI
Exploring the Impact of CRO AI on Pharmaceutical Research and Development
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Why wait? We fix the transparency and control gaps that limit AI scalability - adding traceability, consistency, and lifecycle governance.
Tiered Support
Choose the governance package or advisory tier that matches your organization's needs and maturity level.
Self-Service Governance Packages
Best for: Teams needing fast, ready-to-use governance tools.
- Policy & SOP Pack
- Governance Framework Pack
- Risk & Regulatory Pack
- Additional Pack's Available
- Priced per package
Light Advisory
Best for: Teams that need targeted expert support without a full engagement
- Document Review & Refinement
- Intake & Risk Classification Support
- Alignment Checks for Policies, SOPs, and Assessments
- Advisory Hour Blocks (5 or 10 hours)
Comprehensive Governance & Validation Consulting
Best for: Organizations deploying AI across clinical, regulatory, or safety operations.
- Tailored policies, SOPs, and controls
- Monitoring & drift frameworks
- Cross-functional coaching
- Monthly or Quarterly retainer
In summary, AI solutions in pharmaceutical research are transforming the industry, and WaterworksAI is at the forefront of this innovation.
About Us
Our Team has a mission to reduce development costs and speed new drugs to market, bringing new medications to patients quicker, more cost effectively. We are led by industry experts in pharmaceutical development and technology, and founded by Rebecca D. Jones-Taha. Have a question or comment? Reach out to her directly on LinkedIn.
Pricing Schedule? Free Consultation?
Fill out the contact form and we’ll send pricing or schedule a quick, free 15-minute consultation, whichever you prefer.