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Functional Services

Experienced clinical teams that work as an integral part of your study or portfolio. Our SMEs in biostatistics, data operations and statistical programming 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 development & compliance
  • ADaM modelling incl. Analysis Results Metadata
  • TLF programming & standardisation
  • Custom reporting infrastructure & global utilities
  • PK/PD modelling, analysis & reporting
  • Clinical outcomes analysis
  • Data anonymisation processes
02

Clinical Data Management

  • Data management plans & data validation specifications
  • CRF / eCRF design & annotation (CDASH)
  • EDC database design, build & user acceptance testing (UAT)
  • Edit check programming
  • Data cleaning, discrepancy & query management
  • Data reconciliation (SAE, lab & external vendor data)
  • External data integration (central lab, ePRO, IRT)
  • Medical coding (MedDRA, WHODrug)
  • R-based custom dashboards for data review & study metrics
  • R-environment validation
  • Database lock & archival
  • Submission-ready datasets with full traceability
  • define.xml & conformance checks
03

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.

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Healthcare Data Services