Senior‑led clinical trial design and end‑to‑end execution for medical devices, combination products, and device‑adjacent biotech programs.
Chosen for nearly two dozen FDA data-integrity audits.
Built for inspections, not just enrollment.
Decades guiding high‑stakes medtech and biotech programs.
Health Policy Associates (HPA) provides clinical trial strategy and management services for medical devices, combination products, and device‑adjacent biotech programs. We focus on FDA‑centered programs where data quality, inspection readiness, and credible timelines are crucial.
Whether you’re planning a new study or stabilizing an off‑track trial, we will pressure‑test your trial design and put practical operations in place so you reach closeout with evidence you can stand behind.
Our clinical trial strategy and execution services are designed to turn these pressures into a structured plan: a trial design you can stand behind, a concrete activation plan, and day‑to‑day execution that keeps the study moving with inspection‑ready documentation.
When the stakes are high, HPA turns ambiguity into clear findings, prioritized risks and next steps, so your team stops debating in gray areas and starts moving with conviction.
HPA helps you make decisions and build evidence that holds up under FDA questioning—especially when data integrity, framing, or compliance concerns could derail your program.
Our senior-led team stays with you and manages scope changes transparently, so you avoid handoff drag, reduce rework, and control spend without the change-order spiral.
A trial design and feasibility map that outlines indication, endpoints, follow‑up, sample size, and site mix, stress‑tested against enrollment reality, site capacity, operational burden, and budget. You see what it will actually take to run the study and where the real constraints are before you commit.
A protocol synopsis and operating blueprint translating the agreed strategy into a concrete plan, including key design elements, inclusion/exclusion criteria, endpoints, follow‑up schedule, and operational assumptions—aligned, where applicable, with FDA feedback from Pre‑Sub/Q‑Sub or other interactions.
A coordinated startup and activation package covering site identification and qualification, contracting, IRB/ethics approvals, TMF setup, and core training. The goal is to move selected sites from concept to active enrollment in a consistent, controlled way.
Some programs need more than the basics. When trials are particularly high‑risk or under intense scrutiny, we can extend our clinical trial strategy and execution work to include the following:
A focused working session to reshape trial design to reduce patient counts, duration, and operational burden while staying within what the FDA and good clinical practice are likely to accept.
1.
We start with a short call to understand your product, current regulatory status, recent FDA interactions, key milestones, and urgency.
You get a candid view of whether HPA is a good fit and what type of regulatory consulting engagement would help.
2.
We review a small set of key documents (for example, your latest FDA letter or high‑level plan) to confirm we can help and to scope the work.
This lets us understand the situation without asking your team to assemble a huge data room up front.
3.
You receive a clear outline of the questions we’ll help answer, the depth of review, and the core deliverables.
We define how we’ll work with your team and provide a proposal with the scope, timelines, fees, and information on how scope changes are handled.
4.
Once engaged, we hold a kickoff to align on objectives, roles, and ways of working.
We then perform a more structured review of your FDA correspondence, strategy documents, relevant clinical and safety summaries, and, where relevant, EU/international market files.
5.
We develop or refine the regulatory strategy, confirm or adjust classification and pathway(s), map key submissions, and identify evidence and documentation gaps.
This becomes your FDA Path & Submission Map, Regulatory Gap Assessment, and Regulatory Action Plan.
6.
As you move into submissions and FDA interactions, we review your submission drafts and, when appropriate, provide extended support to sharpen briefing materials and prepare for meetings.
We also provide an Executive Summary for internal leaders and investors and can stay involved to interpret new regulatory feedback and keep the plan on track.
If you also need support with your regulatory classification, pathway, or submissions, our Regulatory Consulting Services help ensure your trial strategy stays aligned with your overall regulatory plan.
When you’re carrying the weight of a pivotal readout, an off‑track study, or a trial design that feels risky, the problem isn’t just earning the last patient visit. It’s being confident the data and documentation will stand up when people start asking hard questions.
HPA brings senior‑led, audit‑grade clinical operations to your program so you can run an efficient trial, keep execution under control, and reach closeout with results you can put in front of your leadership, investors, and the FDA.
