Architecture Advisory for FDA's Architecture Review Board
Direct advisory to the leaders of the Architecture Review Board at FDA's Center for Drug Evaluation and Research (CDER): technology research, tool evaluations, solution architecture, legacy system assessments, and secure data-access guidelines.
Direct
Advisor to Board Leaders
Chief Architect
FDA Program Team Recognition
Exec + Tech
Audiences for Every Deliverable
Active
Since June 2026
The Challenge
Technology Decisions That Are Hard to Reverse
CDER's Architecture Review Board decides which technology solutions enter the center's environment and sets the architectural direction for its IT work. Those decisions shape systems that FDA staff depend on for years.
To decide well, the board's leaders need independent research, honest comparisons, and clear architecture, written so that both executives and engineers can act on it.
New technologies bring both risk and opportunity, and leaders need a clear, plain explanation of each before they set direction
Platform choices are expensive to reverse, so each option has to be compared side by side against FDA's real needs
Application teams need clear, consistent guidance for reaching restricted data securely
Older systems need an honest picture of what they do today, and where they fall short, before anyone plans what comes next
Board decisions have to be written up so both executives and technical teams can act on them
Our Approach
From Question to Decision-Ready Answer
Every request follows the same path: understand the decision, do the research, and hand back something the board can act on.
Frame the Question With Board Leaders
Each piece of work starts with the board's chair and co-chair: what decision is coming, who it affects, and what the board needs to see before it can decide.
Research and Evaluate
We study the technology, product, or system in depth: how it works, what it costs to adopt, what risks it carries, and how it fits CDER's existing systems and standards.
Recommend and Document
We turn the findings into assessment reports, analysis documents, and slide decks for executive and technical teams, and, where teams need to change how they build, into written guidelines they can follow.
The Solution
Six Kinds of Advisory Work
Specific products, systems, and findings stay with FDA. These are the kinds of work we do for the board.
Emerging Technology Research
Plain-language research on new technologies for board leaders: what the technology is, the risks it creates, the benefits it could bring, and what FDA should do now to prepare.
Tool and Platform Evaluations
Side-by-side comparisons of products the agency is considering, measured against FDA's requirements and its current platforms, so the board can make a clear, documented choice.
Secure Data-Access Guidelines
Designed a more secure pattern for how applications reach restricted data, and wrote guidelines for application teams to follow. Delivered to FDA and now in review.
System and Solution Architecture
Architecture for new business and technical requirements across CDER's systems, designed to fit the center's standards and existing platforms.
Legacy System Assessments
Analysis of older systems' past and current architecture, their limits, and a proposed future architecture, so modernization starts from facts.
Briefings for Executives and Engineers
Every finding is written for two audiences: short slide decks for executives who decide, and detailed analysis for the technical teams who build.
The Impact
Trusted Where Decisions Are Made
Direct
Advisor to board leadership
Works directly with the Architecture Review Board's chair and co-chair
Chief Architect
Recognized by the FDA program team
Informal recognition from the FDA program team, not a contract title
In Review
Secure data-access guidelines
Delivered to FDA for application teams and now in review
2 Audiences
For every deliverable
Assessment reports, analysis documents, and slide decks for executive and technical teams
Part of a longer FDA relationship
This work builds on more than two years at CDER on the same contract. Earlier, we built an AI-assisted proof of concept that suggests SNOMED CT codes for clinical text, with human review of every result. We continue to advise on it.
Governance & Delivery
How the Work Gets Done
Advisory Areas
- Emerging Technology Research
- Tool & Platform Evaluation
- Legacy System Assessment
- Data Access Security
Deliverables
- Assessment Reports
- Analysis Documents
- Executive & Technical Slide Decks
- Guidelines for Application Teams
Delivery Model
- Direct Advisory to Board Leaders
- Evidence-Based Recommendations
- Subcontract Through a Federal Prime
For Federal Program Managers
Federal-Specific Considerations
How this capability gets procured, governed, and sustained in a federal environment.
Procurement Path
This work is delivered as a solution architecture subcontract through an established federal prime contractor at FDA. It is available to prime contractors as an architecture and technology advisory subcontract under NAICS 541512. Explore teaming →
Independent Evaluations
We do not resell the products we evaluate. Recommendations are based on the agency's requirements and existing platforms, and every comparison is documented so the board's decision can be explained later.
Security Built Into the Architecture
Secure data access is designed into the architecture and written into guidelines for application teams, so each team does not have to solve it alone.
Have a Similar Challenge?
Whether it's a manual process that needs AI, a legacy workflow that needs modernization, or a compliance requirement that needs architecture. We'd love to hear about it.