The Compliance Bridge

AI is Rewriting Clinical Trials. Compliance Hasn’t Caught Up.

I close the compliance gap before it becomes a problem—ethically, strategically, and fast.

Bridging AI innovation & regulatory integrity in clinical trials.

Purpose

The Compliance Bridge is a strategic consultancy built to close the widening gap between AI innovation and regulatory oversight in clinical trials. As artificial intelligence reshapes how studies are designed, executed, and analyzed, traditional compliance frameworks are falling behind—putting participant rights, data integrity, and institutional credibility at risk.The Compliance Bridge helps CROs, sponsors, and research leaders future-proof their studies through proactive compliance design, participant-centered consent frameworks, and ethical AI oversight.This isn’t just regulatory hygiene. It’s brand protection. It's audit readiness. And most importantly, it's restoring trust between the science and the people it's meant to serve.

Where AI accelerates, oversight must evolve—or be left behind.

The Gap No One Sees

Clinical research is at a tipping point.Artificial Intelligence is being deployed across trial phases: from recruitment algorithms to eConsent tools, from predictive safety signals to automated monitoring. And yet, the systems built to protect human participants—IRBs, FDA frameworks, GCP protocols—are trailing far behind.This isn’t just a lag. It’s a compliance blind spot so vast it risks collapsing trust, integrity, and legal defensibility in AI-enabled trials.I call this space The Compliance Bridge—the critical, unclaimed territory between legacy regulation and next-gen innovation.And I intend to own it.

Technology moves fast. Ethics don’t. Regulation moves even slower.

The Core Truth

Most trial sponsors assume that compliance is a checklist. That IRBs will catch everything. That FDA language will somehow translate AI decision-making.They are wrong.Because when algorithms make eligibility decisions—when machine logic replaces human nuance—participant rights, equity, and safety can be compromised without a trace.And no one will even know.

AI Is Moving Fast. Your Compliance Strategy Isn’t.

Close the Gap

The tools behind modern clinical trials—predictive models, automation, and eConsent platforms—are outpacing the systems meant to govern them. Sponsors assume templates are enough. They aren’t. I help you identify and fix what legacy systems miss.

Diagnose

Map all AI touchpoints in the trial lifecycle. Identify hidden risks in automation, data training, and system dependencies.

Translate

Convert complex AI workflows into language that IRBs, participants, and regulators can actually understand.

Align

Integrate ethical standards with trial goals. Use preemptive consent modifications, policy overlays, & human oversight safeguards.

Defend

Build defensible documentation and audit trails that prove ethical rigor and regulatory foresight.

Christine Roark

Bio

Christine Roark is the founder of The Compliance Bridge, a strategic consultancy helping CROs, sponsors, and research teams navigate AI-driven clinical trial compliance.A former Certified IRB Professional (CIP), her experience spans IRBs, academic institutions, sponsors, and CROs—giving her a rare cross-functional view of research ethics, quality, and operations.Christine is known for identifying risk early, mentoring across teams, and aligning people, processes, and protocols with both GCP standards and real-world conditions.WHAT I STAND FOR:

  • Participant-first design

  • Ethical foresight, not reactive correction

  • Human readability of machine logic

  • Strategic influence over performative compliance