IVD & diagnostics consulting · clinical operations & clinical data management
Clinical studies for IVD and diagnostics companies, with the data systems built by the same person.
I design and run clinical studies for diagnostics companies, build the EDC and data management systems they run on, and write the clinical documentation FDA reviews.
The gap
Most diagnostics teams need two hires and can afford one.
A diagnostics study needs a clinical operations lead who can design it to hold up in an audit, and someone who can build the EDC, data pipelines, and QC. Most small teams can hire only one. The protocol and the data system then get built by different people, and they drift apart.
The strategy hire
Designs the study, then waits for someone else to build it.
The technical hire
Builds to the ticket without the regulatory context that should have shaped it.
The result
Months of back-and-forth and an audit trail no one fully owns.
What I do
Clinical operations and clinical data management for regulated diagnostic studies.
Clinical study design and execution
Study design, protocols and informed consent, IRB submissions, site identification and start-up through close-out, study budgets, vendor and CRO management, and biospecimen management across specimen types, including self-collection.
Regulatory framework alignment
Mapping the program to the diagnostics regulatory lineage: ISO 20916, 21 CFR Parts 809 and 812, Part 11, CLIA, and ALCOA+. Drug-trial frameworks like ICH E6 are built for a different product type and leave gaps when applied to IVD studies.
Regulatory and quality documentation
FDA pre-submission and submission support (EUA, 510(k), De Novo pre-submissions), clinical SOPs, QMS documentation, FMEAs, and Design History Files, built to 21 CFR Part 820 and ISO 13485/QMSR.
EDC build and clinical data management
EDC build, validation, and UAT in Castor, REDCap, and REDCap Cloud. eCRF and edit-check design, Data Management Plans, Data Validation Plans, query management, and database lock.
When the team is thin, I build it myself.
When the team is small or the timeline is short, I build the systems myself. One engagement, one person accountable for both the protocol and the data.
- EDC configuration and integrations with LIMS and reporting systems
- Automated data pipelines and QC in Python, R, and SQL
- Automated QC and verification tooling
- Documented, reproducible checks for audit and submission
Track record
What the work has covered so far.
- 15+ diagnostic studies across molecular, point-of-care, and at-home platforms, from protocol through database lock
- 8 FDA submissions and pre-submissions supported (EUA, 510(k), De Novo pre-submissions)
- Clinical, quality, or data management frameworks built from zero at four organizations
- EDC builds for up to 9 concurrent diagnostic studies
- Specimens including venous and fingerstick blood, nasal and STI swabs, and saliva, including self-collection
How I work
Design first. Pressure-test before building.
Premortem
Start by assuming the program failed an audit, then work backward to find what we missed. The cheapest fix is the one made before anything is built.
Design the operation
Protocol, CRFs, data model, and edit checks designed together, so the study and the data system match from the first subject.
Build and document
Stand up what the study needs, leave behind documentation and tools your team can run on its own, and hand back a record an auditor can follow.
Who you are working with
A scientist who runs the operation and writes the code.
I have 7+ years in IVD and diagnostics, covering study design, clinical operations, clinical data management, lab operations, and FDA submissions, plus the systems underneath them.
I have a PhD in neuroimmunology from the University of Göttingen and completed a postdoctoral fellowship at Yale before moving into IVD and point-of-care diagnostics. Since then I have worked in clinical operations and data management at a diagnostics startup, a non-profit diagnostics developer, a global diagnostics manufacturer, and an IVD CRO.
In most organizations, the person who designs a clinical study and the person who builds its data systems are different people. I do both. I can work through the study design and the FDA meeting, then build the EDC, the pipeline, or the tool that connects them.
- clin opsStudy design, protocols, IRB submissions, site start-up through close-out, biospecimen management
- reg & qualityFDA pre-submissions and submission support, SOPs, QMS, FMEAs, Design History Files
- frameworksISO 20916, 21 CFR Parts 11, 809, 812, 820, ISO 13485/QMSR, CLIA, GCP, ALCOA+
- edcCastor, REDCap, REDCap Cloud
- buildPython, R, SQL, REST APIs, automated QC and reporting
Questions
The things people ask first.
Are you a strategist or a developer?
A clinical operations and data management lead first. The build work is real and it is what sets the practice apart, but engagements are organized around designing and running the study.
What size of company is this for?
Small to mid-size IVD and diagnostics companies, CROs, and early-stage regulated-healthcare startups, especially teams too small to hire a clinical operations lead and a data or engineering hire separately.
Which regulatory frameworks do you work in?
The diagnostics lineage: ISO 20916, 21 CFR Parts 809 and 812, with Part 11, ALCOA+, and CLIA across them, plus 21 CFR Part 820 and ISO 13485/QMSR for quality documentation.
Do engagements include building, or just advising?
Either. Some clients want the design and oversight only. Others want the same person to also stand up the EDC and the data systems. Both work.
How are engagements structured?
Flexible to fit what the program needs: advisory, hourly, project-based, or a fractional clinical operations lead.
How do engagements start?
Book a short intro call using the button at the top. I'll ask about the program, the timeline, and where you think the risk is. If it's a fit, I'll send a scope and a proposal.
Get in touch
Tell me where the program is heading.
Book a short intro call, or send a few lines about the study, the timeline, and where the risk is, and I'll reply.
Book an intro callOr email directly: alexandra@akitzconsulting.com