01
Small & emerging biotech
Move with clarity.
Independent clinical data management
Clinical data
held in focus.
I run Cytra, an independent clinical data management consultancy. I support biotech, pharma, medical device companies and CROs across the clinical data lifecycle — from data management planning and edit-check specifications through reconciliation, medical coding and clean database lock.
Vendor-neutral
Detail-led
Submission-minded
Study signal / 01
In control
cleannoise
setupreviewlock
01 define
02 reconcile
03 lock
15+years in the work
4×client perspectives
1clear through-line
CYTRA / 01 — WHO I WORK WITH
Four contexts.
One standard.
The setting changes. The attention to clean, defensible data does not.
02
Big pharma
Hold the detail at scale.
03
Medical device & diagnostics
Connect the evidence.
04
CROs
Extend the team.
02 / SERVICES
The full study,
held in focus.
Flexible, hands-on support from a clinical data specialist who plugs into your study team — whether for a single deliverable or ongoing across the study.
01
Set the study up to run
Data management plans & documentation
Data Management Plans (DMP), eCRF Completion Guidelines (eCCG) and Data Transfer Agreements (DTA) — clear, audit-ready, study-specific documentation that sets a study up to run smoothly.
Plan / document
02
Build confidence early
Edit-check specs & UAT
Edit-check specification documents, User Acceptance Testing (UAT) and user account management — making sure the database and its checks capture clean, analysable data from first-patient-in.
Specify / test
03
Keep the signal clean
Data review & reconciliation
Listing review and query management — raising, tracking and resolving queries through to a clean database — alongside vendor and external-data reconciliation and SAE / safety reconciliation against the pharmacovigilance database.
Review / reconcile
04
Make every term count
Medical coding
Owning the coding function, not just applying the terms — documented MedDRA and WHODrug conventions, consistent coding across the study, and quality review of adverse events, medical history, concomitant medications and procedures.
Code / quality-check
05
Make safety data agree
Laboratory data
Handling of central and local lab data, normal-range management, unit harmonisation and reconciliation to keep safety data consistent and review-ready.
Harmonise / reconcile
06
Leave capability behind
Mentoring & training
Coaching and mentoring for data management teams and junior data managers — building in-house capability, process discipline and confidence.
Coach / strengthen
03 / THROUGH-LINE
From first-patient-in
to clean lock.
The work is detailed. The experience should feel simple: one steady line through setup, conduct, review and close.
01
Prepare
Make the plan legible.
Clear documentation, well-defined checks and a database built around the study’s actual questions.
02
Steward
Keep the signal clean.
Review, query, reconcile and code with the context to spot what a process alone can miss.
03
Close
Leave a defensible record.
Traceable, consistent data that is ready for sponsor oversight, analysis and the next decision.
04 / EXPERIENCE
Experience that
stays close to the work.
Cytra is built on more than 15 years of hands-on clinical data management experience across a wide range of therapeutic areas, study phases and sponsors — from small emerging biotech to big pharma, medical device companies and CROs.
That means you get pragmatic, standards-driven support from someone who has done the work: writing the specifications, testing and validating the setup, chasing the queries, reconciling the data and getting studies to a clean lock. No hand-offs, no learning curve — just reliable data management you can trust.
Therapeutic experience
Oncology
Cardiovascular
Aesthetics & Dermatology
15+years in clinical
data management
data management
End-to-endStudy conduct through to clean lock
4Client types, one standard of quality
IndependentVendor-neutral & flexible
05 / QUALITY & STANDARDS
Regulatory-grade
by default.
Every deliverable is produced to Good Clinical Practice and industry data standards, with documentation and traceability that stand up to sponsor oversight, audits and inspections. Personal data is handled in line with EU and UK GDPR.
ICH-GCP (E6)
FDA: 21 CFR Parts 11, 50, 56, 312, 812
EMA: EudraLex Volume 10
MHRA: UK Good Clinical Practice
EU GDPR & UK GDPR
MedDRA & WHODrug
06 / CONTACT
Let’s make the
next decision clearer.
Whether it's a full data management engagement or a single specialist deliverable, get in touch and I'll get back to you.
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