Clinical Data Management Consulting

Director-level CDM
expertise, without
the full-time hire.

Fractional leadership. Full commitment.

Stafford Consulting provides fractional and project-based clinical data management leadership to startups and growing biotech sponsors — so you hit database lock on time, stay inspection-ready, and submit with confidence.

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25+
Years of experienceHands-on clinical data management
6
Core service areasEnd-to-end data lifecycle coverage
3
Engagement modelsHourly, retainer, or fixed-fee
I–IV
All trial phasesGlobal multi-study programs
Standards & Compliance
ICH-GCP FDA 21 CFR Part 11 CDISC / CDASH / SDTM GCDMP ISO 14155
Why Stafford

Built for the way
startups actually work.

Early-stage sponsors need senior expertise — not a full-time headcount commitment. Stafford Consulting was built to close that gap.

01
Senior expertise, flexible terms
You get a 25-year Director-level CDM leader on hourly, retainer, or fixed-fee terms that match your program stage and budget. No recruiting overhead, no benefits cost, no long-term commitment.
02
End-to-end, not just advisory
I don't just consult — I build your Data Management documents, oversee your EDC, manage your vendors, program your patient profiles and data review listings, and get you to lock.
03
Inspection-ready from day one
Deep regulatory experience across FDA, ICH-GCP, and CDISC standards means every deliverable is built audit-ready. No scrambling before an inspection — it's built in from the start.
Core Services

Everything your data
program needs.

Six service areas covering the full clinical data lifecycle — from database build to submission-ready datasets.

Clinical Data Management
Data Management Plans, EDC build oversight, edit check specifications, data cleaning strategy, query management, and database lock.
DMPEDCDB Lock
Biometrics Team Leadership
Fractional biometrics team management, stat programming vendor coordination, DMC & DSUR deliverables, and cross-functional governance.
GovernanceDMCDSUR
SOP & Process Development
CDM SOP authoring and review, work instruction development, training framework creation, and GCDMP/ICH-GCP compliance alignment.
SOPsWork InstructionsTraining
Clinical Programming
Patient profile programming, data listing programming, TLF-ready output development, and UAT/QC of programmed deliverables.
ProfilesListingsTLF
Data Visualization & Analytics
Interactive clinical dashboards in Power BI, Spotfire, and Tableau; patient-level data review tools; submission-ready displays.
Power BISpotfireJReview
CRO & Vendor Oversight
CRO selection and qualification, vendor performance management, audit readiness support, external data reconciliation, and regulatory submission support.
CRO MgmtAudit ReadySubmissions
How It Works

Simple to start.
Easy to scale.

A straightforward path from first conversation to deliverables in your hands.

STEP 1
Discovery call
A free 20-minute conversation about your program, timelines, and where you need senior data management support.
STEP 2
Scope & agreement
We agree on deliverables and the engagement model that fits your stage: hourly, retainer, or fixed-fee, documented in a clear SOW.
STEP 3
Delivery
I start work quickly, report progress regularly, and stay accountable through database lock and beyond.
Technology & Platforms

Tools I work in.

Deep hands-on experience across the leading EDC, analytics, and data engineering platforms used in clinical research today.

EDC & Clinical Platforms
Medidata RaveOracle ClinicalMedrioMerative ZeltaOpenClinica
Data Engineering & Analytics
PythonSQLAdvanced ExcelPower Platform
Visualization & Review
Power BISpotfireTableauJReview
Get in Touch

Let's talk about
your program.

Available for select engagements. Fill out the form or reach out directly — responses within one business day.

Send a message

Your information is kept strictly confidential. No spam, ever.

✓  Thank you — your message has been received. I will be in touch within one business day.
"The right CDM partner changes everything for an early-stage program."
Email directly
lstafford@staffordcdm.com
Call or text
978-216-4463
Response within one business day
20-minute discovery call to understand your needs
No commitment required to have the conversation
Capability statement and rate card available on request
Based in Boston, MA · Available remotely nationwide