We sat down with Fluence's Senior Director of Product Quality and Compliance, Candace Anderson, to talk about why compliance isn't a checkbox, and what Fluence is actually doing to build infrastructure drug developers can rely on.

Let's start with you. What's your background, and how did you end up focused on quality and compliance in this space?

I’ve spent 17 years at global Contract Research Organizations (CROs), the last 10 of which I worked with high-risk clinical data platforms. These are the kind of environments where a data integrity failure doesn't just create a headache; it can derail a study or put patients at risk. That's where I learned what I think is the most important lesson in this work: quality cannot be retrofitted. You must design it from day one, or you spend years cleaning up.

I was drawn to Fluence not only for its mission (with which I have deep alignment), but because, even as a start-up, it has real operational traction in a genuinely complex space, and was ready to take the next step toward a formal compliance infrastructure. It’s a rare combination, and the challenge of applying what I’ve learned to build something sturdy from the ground-up felt like a once-in-a-lifetime opportunity.

For people who may not be deep in the clinical trial world: why does compliance matter so much here?

Psychedelic therapy is not like most drug development, and I think it's worth saying that plainly. You are not testing a pill that either works or doesn't. You're studying long, complex therapeutic interactions. Preparation sessions, extended treatment sessions, integration visits - delivered by highly trained clinicians who need to provide a specific kind of care, consistently, across sites and countries. Not to mention this is all sitting on top of a history of mistrust, skepticism, and drug policies that hindered research. 

The data coming out of those interactions is extraordinarily sensitive. Patients in altered states sharing things they may have never told anyone. Many of them are participating because they're dealing with PTSD, treatment-resistant depression, or end-of-life distress. This is a vulnerable population in every sense of the word.

All of this context changes the math. Tolerance for error on data handling, system access, and audit trails is effectively zero. As the FDA begins reviewing these trials, the expectations are only going to get more explicit. Systems must be validated, processes must be documented, and quality must be the north star. We have to get this right.

So what is Fluence actually doing to formalize its compliance posture?

Quite a bit, and it's all connected. Let me walk through it.

The foundation is software validation. We have two proprietary platforms: Fluence Sync, our clinical trial training management system, and Fluence Sessions, our scheduling, video, and AI-enabled practice environment. Both are going through formal validation. That means documented risk assessments, test scripts, traceability matrices, and evidence packages that prove each system does what it claims to do, consistently and reliably, in alignment with FDA and EMA guidance on electronic systems in clinical investigations.

This is not box-checking. A validated system means a sponsor can point to it in an audit and say, "we know exactly what this does, how it's controlled, and what happens if something changes." That is a very different conversation than working with a vendor whose answer is "trust us, it works."

What else is in scope beyond the platforms themselves?

Beyond validation, I’m engineering our SOP landscape and upskilling Fluence staff with training on the importance of compliance and quality management. Our core process will be documented in a way that's consistent, version-controlled, and tied to clear roles and responsibilities. Who approves what? Who has access to what? What happens when something goes wrong? None of those should be open questions.

That ties into change management and change control. In a regulated environment, you cannot just push an update to a system or process and move on. Changes need to be assessed, approved, tested, documented, and rolled out strategically. We're building the infrastructure to make that a normal way of operating.

We're also building a Quality Management System. The QMS gives us a structured way to track quality events, anything from a minor process deviation to a more significant issue, and to make sure the right corrective and preventive actions are identified and closed out. It's how you actually learn from problems instead of just reacting to them.

That's a significant undertaking. Where does it fit in the context of what Fluence is building on the product side?

The product roadmap and the compliance roadmap are designed to move together. Fluence Sync is already live across four sponsors and six active clinical trials. AI-generated session analysis feeds directly into Sync and gives trainers a single place to review transcripts, adherence reports, and video. You cannot do AI-assisted review in regulated research without a validated system underneath it. It's a non-starter.

Fluence Sessions is launching next, and it's designed to do two things. First, consolidate what was previously a patchwork of tools (Calendly, Zoom, Grain, and Zapier) into one secure, integrated scheduling and recording environment. Second, support new features that will streamline the role-play practicums our trainees rely on. Better data continuity, fewer handoffs where things can go wrong. The compliance work is what makes that consolidation something sponsors can actually rely on, rather than something that's just operationally convenient.

Let's talk about the regulatory landscape for a moment. How does that factor in?

The draft guidance on psychedelics and the recent Executive Order + voucher program tells us the FDA is really paying attention. They understand this field has unique characteristics and they expect sponsors, and the vendors supporting those sponsors, to be operating with appropriate rigor.

For us, that's actually clarifying. We're not guessing at what "good" looks like. We're building to a standard that's being articulated in real time, by the same regulators our sponsors answer to.

The first marketing approval of psilocybin could come any day now. When it does, the pressure on training infrastructure, and on the compliance posture of the vendors supporting that infrastructure, is going to accelerate fast. Being ready for that moment means doing the work now, not after.

Is there a tension between moving quickly as a growing company and building robust compliance infrastructure?

Honestly, not as much as people expect, as long as you set it up right. The misconception is that compliance slows you down. What it actually does is reduce rework, reduce risk, and make scaling easier.

When processes are documented and roles are clear, onboarding new team members is faster. When system and process changes are controlled, updates to validated platforms don't turn into audit emergencies. When a QMS is tracking quality events, you catch problems and see patterns while they're still small.

The alternative– moving fast without the infrastructure– looks efficient right up until something breaks or your data scale forces a cleanup that derails delivery for months. And in clinical research, the cost of something breaking is not just operational. It's human.

What would you want drug developer partners to know about where Fluence is heading?

We're building to be a long-term partner, not just a vendor. Drug developers operate under enormous scrutiny. Their systems, their data, their clinical workflows are all subject to regulatory review. When they bring on a technology and training partner, they're extending that responsibility to us. We do not take that lightly.

This framework is not about optics, it's about being the kind of company that sponsors can point to in an audit and not have to worry. 

I consider psychedelics to be a kind of revolution, a turning point, an opportunity, that we have as a society to truly re-engineer our approach to mental health, and even public health as a whole. I’m proud to work with a company that sees the value in helping to deliver care with rigor, candor, and integrity at every layer of the system. That's what we're building toward.

Fluence is a training infrastructure company serving drug developers, sponsors, and CROs running psychedelic clinical trials. To learn more about Fluence Sync, Fluence Sessions, or our compliance programs, reach out at info@fluencetraining.com.