Clinical Data Management
Database design, data cleaning, CDISC SDTM mapping, and database lock — delivered with rigorous quality controls and full audit traceability.
Trusted by global pharmaceutical leaders
Precision Data.
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Precision Data.
Accelerated Discovery.
Clinical data management and analytics services trusted by global pharmaceutical leaders to accelerate regulatory submissions and unlock trial insights.
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Clinical Trials Supported
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On-Time Delivery Rate
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Regulatory Submissions
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Countries of Operation
Capabilities
Our Capabilities
End-to-end clinical data services and proprietary analytics technology, delivered by 300+ specialists across six core practice areas.
Biostatistics
SAP authoring, SAS and R programming, TFL production, integrated summaries of safety and efficacy for global regulatory submissions.
Medical Writing
Clinical Study Reports, Investigator Brochures, and submission-ready dossiers for NDA, BLA and MAA filings across major markets.
Pharmacovigilance Analytics
Safety database operations, signal detection, SUSAR reporting, and aggregate safety reporting (PBRER, DSUR) at global scale.
Regulatory Data Standards
CDISC compliance, define.xml generation, ADaM datasets, and FDA/EMA submission readiness with eCTD-compliant deliverables.
NexaCore™ Platform
Proprietary TechnologyOur proprietary clinical analytics platform — real-time data quality monitoring, automated CDISC mapping, and multi-study portfolio insight.
NexaCore™
NexaCore™ — The Intelligence Layer for Clinical Data
A validated, 21 CFR Part 11-compliant analytics platform built by clinicians and statisticians for clinicians and statisticians. Plug it into your existing EDC or use it standalone.
- Real-time data quality dashboards
- CDISC-compliant automated mapping
- 21 CFR Part 11 validated environment
- Multi-study portfolio analytics
- API-ready integration with Medidata Rave & Veeva Vault
- Role-based access with full audit trail
Therapeutic Expertise
Deep Domain Knowledge Across Therapeutic Areas
Oncology
Cardiovascular
Respiratory
Rare Diseases
Immunology
Neuroscience
Vaccines
Metabolic Disorders
Why Nexagen
Built on Rigour, Trust and Scientific Excellence
A decade of partnership with the world's most demanding clinical programmes — built on three uncompromising commitments.
GxP Excellence
ICH E6(R2) compliant, ISO 9001:2015 certified, with full audit-readiness at all times. Every dataset, every deliverable, fully traceable and inspection-ready.
Global Reach
Regulatory expertise across the FDA, EMA, PMDA and 35+ national authorities. Multilingual operations supporting trials in over 20 countries.
Science-First Team
300+ specialists including PhDs, biostatisticians, and certified data scientists — combining methodological depth with deep therapeutic-area expertise.
Leadership
Meet the People Behind Nexagen
Decades of combined experience across pharma, biotech and the regulatory sciences.
Dr. Sarah Whitmore
Chief Executive OfficerFormer VP of Clinical Operations at a top-10 pharma. PhD in Biostatistics, University of Cambridge.
Dr. Mei-Ling Chen
Head of BiostatisticsTwenty years authoring SAPs for global Phase II/III oncology trials. PhD in Statistics, Stanford.
Mr. Daniel Okafor
Global Alliance ManagementBuilt strategic alliances with five top-20 pharma sponsors. MBA, INSEAD; MSc Pharmacology.
Mr. Thomas Laurent
Head of Quality AssuranceEx-MHRA inspector. Specialist in 21 CFR Part 11, ICH E6(R2) and EMA-equivalent quality systems.
Nexagen's biostatistics team delivered our Phase III TFLs three weeks ahead of schedule. Their CDISC expertise and NexaCore™ platform gave us real-time visibility we'd never had before.— VP Clinical Operations, Top-10 Global Pharmaceutical Company
Global Pharma Partner
Global Pharma Partner
Global Pharma Partner
Get in touch
Email
info@nexagendata.com
Start a Conversation
Whether you're scoping a new programme or evaluating partners, our team will respond within one business day.
Headquarters
200 Aldersgate Street
London, EC1A 4HD
United Kingdom
Phone
+44 20 7000 0000London, EC1A