WST Consulting — Boutique Clinical Data Management
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FIG 01 · SIGNAL RESOLUTION
STATUSRESOLVING
OPEN QUERIES214
+ Boutique Clinical Data Management · Chicago

Your database is your clinical trial.

WST is a founder-led data management practice that works as an extension of your team, from the first record captured to a locked, submission-ready database.

Field DossierWST·01
Practice
Clinical Data Management
Model
Founder-led · boutique
Scope
First record database lock
Role
An extension of your team
The WST PositionNo. 01 · Data Management

You don’t need a CRO to run your data.

For the clinical side of a trial, a big CRO earns its keep. For data management, it quietly costs you more than it should. Money, months, and a capability you never end up owning.

01 · What sponsors get wrong

Ask most sponsors who should run their trial’s data and the answer is a large CRO. A whole department. That instinct serves the clinical side well and data management badly. What you tend to get is a “senior” data manager working as a relay, shuttling information between clinical, medical, and the one person who actually built the database. One genuinely technical data manager (someone who reads the monitoring and statistical plans and programs the database) replaces the whole chain.

The thesis
Your database is your clinical trial.

It’s how your study is represented to the FDA — no matter how well it was run at the bedside.

02 · Why the default fails

When a study goes sideways it starts with communication. We build from the protocol, but most of what matters lives in how the sites actually operate, and when clinical isn’t aligned with them that gap flows straight into the data. Bundling makes it worse. Data management lands in the CRO contract, the promised team turns out to be one person, and everything moves through a slow loop of deliver, review, feedback, digest, agree, repeat. A process built to guard against the worst-case client punishes the one who just wanted a five-minute conversation.

03 · The alternative

A CRO is a vendor — the systems, SOPs, and know-how stay theirs, and when the contract ends you keep only deliverables. A consultancy is an extension of your team: we work inside your systems, write your SOPs, and build your documents with you. You come out faster, cheaper, and holding a data management function that is ready for every study after this one.

+ The Cost of the Default

Bundling data management with your CRO is the expensive option.

It rarely looks expensive on the quote. The cost shows up later: in the months the review loop adds, in the team you are billed for at department rates but never actually meet, and in the capability you have to buy again next study. Shortcuts taken at capture come due at lock, when there is no time left to fix them. Nothing on a trial costs more than a submission that slips.

The premium option — at a fraction of a CRO’s cost.
Senior-owned, white-glove data management, priced for one accountable expert rather than a department.
+ The Record

Every study locked on time. Zero findings against the work.

Seven years, roughly fifty studies, and a record that hasn’t slipped once. Every study has landed clean.

ON SCHEDULE
0%
of databases locked on or ahead of schedule
AUDIT FINDINGS
0
findings against the work, across every study
STUDIES
~0
studies supported across seven years
BUILT & LOCKED
~0
databases built from scratch and locked
Commended by the MHRA  ·  FDA inspection closed with no findings against the data.
+ Capabilities

One owner, the entire data lifecycle.

From data management strategy through a locked, submission-ready database. Every discipline your trial’s data runs on, with one senior owner accountable for all of it.

+ Resolution
Raw capture, funneled down to a single locked record.
Where our clients are
Where their trials run
An extension of teams in every major biotech hub.
+ Data Protection
NDA · 21 CFR PART 11
Your environment
EDC eTMF SAS
WST works inside
Your data stays in your systems. We work inside them and never move it out.
+ Coding
STUDY WST-204
Queries closedPENDING
SAE reconPENDING
Coding completePENDING
Ext. reconPENDING
QC passedPENDING
DATABASEUNLOCKED
+ Audit Trail
21 CFR PART 11 · COMPLIANT
TIMECHANGEUSERHASH
The lane · protocol to lock

Every handoff in a study is a chance for something to drift. Below is the same trial with one lane running the full length of it.

Swipe to follow the lane →
01

Data Management Strategy

The data management plan that governs your study, scoped to your protocol before the first record is captured.

02

EDC & Database Build

Study databases and CRFs built for clean capture from day one, in the EDC platform your trial already runs on.

03

Edit Checks & Validation

Programmed checks that flag discrepancies the moment data arrives, not months later at lock.

04

Query Management

Discrepancies raised, tracked, and resolved with your sites, driving the open-query count to zero.

05

Risk-Based Monitoring

Central and statistical signals that focus attention where the data (and the risk) actually is.

06

Medical Coding & CDISC

MedDRA and WHODrug coding, and CDISC-aligned data structured for submission: SDTM and ADaM, built in collaboration with your programming team.

07

Statistical Monitoring

Ongoing review of trends and outliers to catch quality issues while there’s still time to act.

08

SAS Programming

Validated SAS programming for derivations, datasets, and the analysis-ready outputs your biostatisticians rely on.

09

Dashboards & Reporting

Live metrics and study reporting that give your team a clear, current view of data health at any moment.

10

Reconciliation & Database Lock

SAE and external data reconciled, then a clean, auditable database lock your submission can stand on.

+ Standards · Platforms · Experience

Fluent in the tools your trial already runs on.

Biology comes in as biology. It leaves as a standardized, submission-ready dataset.

Standards
CDISC · CDASH · SDTMGCDMPMedDRAWHODrug21 CFR Part 11ICH-GCP
EDC Platforms
Medidata RaveVeeva Vault CDMSOracle InFormMedrioTrialMaster
Programming
SASPython
RBQM & Analytics
CluePointsMedidata DetectElluminate
Therapeutic Areas
OncologyRare DiseaseCardiometabolicNeurology / CNSImmunology & InflammationInfectious DiseaseVaccines
Broad by design, with the deepest track record in oncology and rare disease.
A selection of recent sponsors
A global mRNA & vaccine developer
A specialty pharma in drug delivery
A clinical-stage rare-disease biotech
A rare-disease specialty pharma
+ Leadership

The founder behind the work.

WST is founder-led and built to scale. Jake owns the work today and brings in vetted specialists as an engagement requires.

Founder & Principal Consultant
Jake Olson
7 years in clinical data management
BASEDChicago, Illinois
FOUNDEDWST in 2024
BEFORESponsor-side lead DM

Jake came up through clinical research from the ground up. He started on-site as a clinical coordinator, where he saw how operations really run at site level, before moving into data management. He built his DM foundations on the CRO side, then moved sponsor-side as a Lead Data Manager and Central Monitor at a large international pharmaceutical company.

Since 2024 he has run WST independently as lead data manager for clinical-stage biotech sponsors, owning studies end to end: protocol input and eCRF design through database lock, inspection readiness, and archival. He was the primary data-management contact through an FDA inspection that closed with no findings against the data, and has been commended by the MHRA for his work.

View WST on LinkedIn →
+ Proof

What partners say.

Recommendation · LinkedIn

“What sets him apart is his combination of strategic insight and practical execution.”

I really value the way Jake thinks about the practical application of ICH E6(R3). When he worked for me in Central Monitoring, he was not only an incredible team player, always willing to take on whatever was needed, but also someone who consistently looked for smarter, more efficient ways to get the work done, often proposing or building automated solutions to help the entire team.

He brings a balanced, thoughtful perspective to risk-based quality, embracing the shift away from high-cost, low-value activities like blanket SDV, while also challenging the idea that “risk-based” means doing less overall. His ability to articulate how “non-critical” data can still inform critical endpoints, centralized monitoring, and AI/ML models shows real systems-level thinking.

What sets him apart is his combination of strategic insight and practical execution. He understands how to translate evolving guidance into scalable, high-impact operational solutions, all while being someone you can rely on to step up, collaborate, and deliver. He would be a strong asset to any clinical development or data quality organization, and I truly miss having him on my team!

Heidi McIntyre
Director Clinical Operations, Spyre Therapeutics
January 2026 · Heidi managed Jake directly
Operating principles
Trust, but verify
Pull the source, confirm the facts, assume nothing.
Flag it, then fix it
Anyone can point at a problem. We arrive with the solution.
Calm under pressure
When it hits the fan, the answer is options — not panic.
+ Ways To Work

Engagement models that fit the study.

MODEL 01

Full-study data management

End-to-end ownership of your trial’s data, from strategy and build through to a clean, locked database.

MODEL 02

Embedded & fractional

A senior data manager plugged directly into your team, at the fraction of capacity your study actually needs.

MODEL 03

Rescue & remediation

Stalled data, an audit on the horizon, or a lock in jeopardy. We take over the database, triage what is actually broken, and get it back on schedule.

+ Questions

The things teams ask first.

As soon as a contract is signed and system access is granted. There’s no large-CRO onboarding machine to wait on. Once the paperwork is done and we’re in your systems, we’re working.

Yes, routinely. We often provide sponsor-side oversight of a CRO’s data management deliverables, keeping them on time and to standard. Or we own the DM function directly while a clinical CRO handles operations.

Every engagement runs under a confidentiality agreement, and we work inside your validated, 21 CFR Part 11-compliant systems and SOPs, so your data stays in your environment. We’re well-versed in Part 11, ICH-GCP, and inspection-readiness expectations.

Anything from first-in-human Phase I to global Phase III. Small and mid-size studies are where a boutique delivers the most value, but the model scales: we bring in additional specialists as a study’s scope requires.

It starts with a conversation. We scope what you actually need (a full build, fractional support, or a rescue) and come back with a clear plan and timeline, then plug into your team and systems and take ownership of the piece we’ve agreed on.

A named senior owner who does the work personally. At a CRO, the experienced name on the proposal is rarely the person in your database; the build, the checks and the queries get handed down, and you reach that person through a process rather than a phone call. Here the person accountable for your data is the person programming it, and every study we have owned has locked on time with zero audit findings.

+ Careers

We’re building the bench.

WST is growing beyond its founder. We want data managers, programmers, and clinical data associates who are after real ownership, a genuine variety of studies, and senior mentorship instead of a seat in a CRO’s org chart. If that sounds like you, get in touch.

Apply to WST
Roles, what we look for, and an application form.
+ Get In Touch

Let’s talk about your study.

Tell us where your data stands and we’ll tell you how we’d help. You’ll be talking to the senior data manager who would run the work, usually within a day.

hello@wstconsultingagency.com
Chicago, Illinois