Technology and quality, built to pass inspection.
Proctored helps healthcare, life sciences, and clinical research organizations ship better technology, strengthen their quality systems, and grow without breaking compliance.
We work with founders, executive teams, and investors on the problems where thoughtful execution matters as much as strategy: modernizing platforms, standing up product organizations, getting audit-ready, and making high-consequence decisions with confidence.
In regulated industries, the hard problems are never just one problem.
Growth creates complexity, and in healthcare, life sciences, and clinical research that complexity comes with consequences most industries never face. A platform decision becomes a validation problem. A delivery bottleneck becomes an audit risk. A quality gap becomes a regulatory finding.
Product, technology, operations, and quality don’t live in separate boxes; they constantly shape one another, and solving one in isolation tends to break another. Most firms are built to work on only one of them.
We’re built to work on how they fit together. That’s the difference between advice that sounds right and change that survives your next inspection.
Get audit-ready and stay that way.
Build and strengthen Quality Management Systems, prepare for sponsor and regulatory inspections, and turn compliance from a fire drill into an operating capability.
Modernize technology without breaking compliance.
Platform modernization, architecture, and integration for organizations that can’t afford to trade speed for control. We help you move faster while keeping validation, traceability, and audit-readiness intact.
Build a product organization that ships.
Product strategy, delivery, and operating models for teams that need to turn a roadmap into reliable execution — and adopt emerging technology, including AI, responsibly in environments where “move fast and break things” isn’t an option.
Make the right call before you invest.
Technology due diligence, operational assessments, and product evaluations that give founders, boards, and investors a clear-eyed read on what they’re really buying, building, or backing.
Decades of getting hard things across the line.
Before Proctored, Mike led the work behind outcomes like these:
Led the transformation of a portfolio of regulated clinical-trial platforms from single-tenant enterprise architecture to multi-tenant: improving scalability, release predictability, and commercial readiness without loosening the compliance posture.
Built and scaled the professional services and delivery organization at a high-growth clinical technology company from the ground up: maturing operations, governance, and structure through the run-up to its $240M acquisition.
Led an organizations through sponsor qualification audits, meeting the compliance and delivery bar required to qualify as an approved vendor and win the sponsor’s business.
Stood up Quality Management Systems from scratch, giving a regulated software organization the governance, controls, and audit-readiness to operate with confidence and scale.
Healthcare · Health Tech · Life Sciences · Clinical Research
Led by Mike Demo.
For more than twenty years, Mike has helped regulated healthcare and life sciences organizations solve the problems where product, technology, operations, and quality collide. He was a senior leader at Trifecta Clinical through the growth phase that led to its $240M acquisition by WCG, stayed on post-close as VP of Applications and Business Analytics to drive integration and synergy realization, and led portfolio-level product and multi-tenant platform transformation across regulated clinical-trial software at Sitero.
Today, through Proctored, he works with founders, executive teams, and investors facing exactly those challenges; supported by a vetted network of senior operators he brings in when an engagement calls for it.
His philosophy is simple. Our objective is never dependency. It is capability. When our work is done, your organization should be stronger than when we arrived, not more reliant on us.
Let’s build what’s next.
Whether you’re modernizing a platform, standing up a product organization, preparing for an inspection, or deciding where to invest, we’d welcome the conversation.
