Who we are
RegAlign was built for clinical research organizations that can't afford to treat quality as an afterthought. We embed fractional regulatory and quality leadership directly within sponsors, CROs, and research site networks — so inspection readiness becomes part of how your organization operates, not a scramble when auditors arrive.
We build systems that last. Structured SOPs, internal audit programs, compliance training, quality assurance frameworks — all tailored to your organization's complexity, not templated. The goal isn't to pass the next inspection. It's to make you the kind of organization that doesn't worry about one.
Why Work With RegAlign
We built RegAlign around a simple commitment: the people you talk to are the people who do the work.
In clinical research, it's easy to sell an engagement and hand it off. We don't operate that way. When Darian or George makes a commitment to your organization, we're the ones who fulfill it — directly, personally, and with our names attached to every deliverable.
We'd rather lose an engagement than overpromise on one. That means we'll tell you honestly what we can do, decline work that isn't the right fit, and hold ourselves accountable when something falls short. You shouldn't have to wonder whether what you were promised is what you'll receive.
At RegAlign, quality isn't a checkpoint — it's embedded into every process. We work closely with organizations to understand their workflows, study portfolios, and sponsor requirements, then build practical systems that simplify compliance, reduce administrative burden, and hold up under scrutiny.
Whether you need start-up support, regulatory file management, or ongoing quality oversight, our engagements are tailored to your organization's actual needs — not a generic framework dropped on top of them. We operate as an extension of your team, not a vendor handing off a deliverable.
Our Approach
Our Executive Team
Darian founded RegAlign to address a challenge she repeatedly encountered throughout her career; clinical research organizations often need experienced regulatory and quality leadership but lack the resources to maintain it internally. With experience spanning NIH-funded academic research, sponsor services, and site operations, she has built expertise across regulatory strategy, feasibility, quality systems, and clinical trial execution.
Prior to founding RegAlign, Darian managed cardiovascular imaging studies at The University of Texas at Arlington, contributed to peer-reviewed research, and supported sponsors and research sites through regulatory submissions, contract development, and operational planning. As CEO, she leads the firm’s strategic direction, client partnerships, and service delivery, helping organizations strengthen compliance, improve operational performance, and build sustainable quality frameworks.
Darian Trojacek, MSc | Founder & Chief Executive Officer
George Lott, MS, PA-C, CTPro | Co-Founder & Chief Operations Officer
George oversees operations at RegAlign, bringing experience across sponsor, CRO, site, and site network environments. His background includes clinical trial execution, commercial strategy, and operational leadership in precision oncology, cell therapy, and decentralized clinical trials.
Throughout his career, George has focused on improving study execution by aligning stakeholders, strengthening site performance, and reducing operational barriers that affect enrollment and timelines. As COO, he translates regulatory and quality requirements into practical operational strategies, helping organizations build scalable processes that support compliance, efficiency, and long-term growth. His cross-functional experience enables clients to bridge the gap between strategic planning and day-to-day execution while maintaining a strong foundation of quality.
Contact us
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