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Functional Services

Experienced clinical teams that plug into your study or portfolio. Our people have supported numerous drug submissions to regulators worldwide, across all major therapeutic areas.

01 Engagement Models

How we work with you

Project-based

A defined scope and deliverables for a study or submission.

Functional Service Provider (FSP)

A dedicated team that owns a function on an ongoing basis.

Staff augmentation

Skilled individuals who join your team under your processes.

02 Capabilities

Functions we support

01

Biostatistics & Statistical Programming

  • Study design input & sample size estimation
  • Statistical analysis plans
  • SDTM & ADaM incl. Analysis Results Metadata
  • TLF programming & standardisation
  • Custom reporting infrastructure & global utilities
  • PK/PD modelling, analysis & reporting
  • Clinical outcomes analysis
02

Clinical Data Management

  • Data collection standards
  • Cleaning & reconciliation
  • Data anonymisation
  • Submission-ready datasets with full traceability
  • define.xml & conformance checks
03

Clinical Operations

Clinical Data Modelling and Analysis Processes
  • SDTM development & compliance processes
  • ADaM modelling incl. Analysis Results Metadata
  • PK/PD modelling, analysis & reporting
  • Data anonymisation processes
  • Clinical outcomes analysis
04

Medical Writing

Clinical & Regulatory Writing

Protocols, protocol summaries, investigator brochures, informed consent documents, case report forms and clinical study reports.

Scientific Publications

Original research papers, review articles, case reports, abstracts and book chapters.

Literature Reviews & Evidence Synthesis

Structured searches, critical appraisal and evidence summaries.

Medical & Patient Education

Accessible content for healthcare professionals, patients and caregivers.

Talk to us about your next study.

Contact Us

Working with hospital or real-world health data instead?

Healthcare Data Services