Sector: Biotechnology & Life Sciences
Employees: 120
Operating Regions: UK, EU, US
Regulatory Landscape: GDPR, UK GDPR, US State Privacy Laws, Clinical Research Governance
The Challenge
A growing biotech business operating across multiple jurisdictions was facing increasing pressure to maintain accurate and defensible compliance. Traditional consultancy support was slow, expensive, and difficult to scale. Advice often arrived days or weeks after questions were raised, creating uncertainty and risk in a fast-moving, highly regulated environment.
The business needed a model that delivered speed without compromising accuracy, supported multiple jurisdictions, and provided clear governance backed by expert opinion without the cost and rigidity of a traditional consultancy retainer.
The Clear Assure Solution
Clear Assure replaced the legacy consultancy model with an AI-driven compliance platform verified by qualified experts.
Every compliance query raised by the business was assessed and responded to through AI-powered workflows, ensuring consistent and structured guidance. Where risk or complexity increased, queries were escalated seamlessly to experienced compliance professionals for review and validation.
This hybrid approach delivered accurate compliance advice, verified by experts, while maintaining speed and consistency across the organisation.
Clear Assure enabled the biotech company to manage compliance obligations across the UK, EU, and US within a single platform, providing jurisdiction-specific responses aligned to local regulatory requirements.
Key Outcomes
Accurate compliance through AI, verified by experts
AI delivered immediate, structured responses for day-to-day compliance queries, with expert oversight ensuring accuracy and defensibility for higher-risk decisions.
A new compliance model
Clear Assure removed reliance on traditional consultancy retainers, replacing them with continuous governance, transparent audit trails, and expert-validated decision-making.
Fast response times
The business reduced response times from days to minutes, enabling teams to move quickly without delaying research, partnerships, or operational decisions.
Multi-jurisdiction support
Clear Assure provided clear, localised guidance across multiple jurisdictions, eliminating confusion caused by overlapping regulatory frameworks.
Reduced cost
By replacing ad-hoc consultancy fees with a scalable platform model, the organisation significantly reduced compliance spend while increasing governance and oversight.
The Result
The biotech company now operates with greater confidence, clarity, and control over its compliance obligations. Clear Assure has become a core part of its governance framework, supporting growth, international expansion, and regulatory trust—without the friction and cost of traditional compliance models.