Solution

Biometrics and Data Management

Accurate, high-quality and timely biostatistics from first-in-man to Phase IV trials.

Greenline Clinical Research's North America region team of in-house biostatisticians and statistical programmers delivers accurate, high-quality and timely biostatistics services. These include statistical planning, analysis and reporting.

The Greenline Clinical Research biostatisticians bring extensive experience of biostatistics services, from first-in-man to Phase IV trials, across a broad range of therapeutic areas.

Key biostatistics services

Designing Statistical Analysis Plans (SAP)
Coordinating and managing DSMB outputs and meetings
Consulting on clinical trial design and protocols, including adaptive design studies
Preparing Statistical Reports — Interim, Final and Clinical Study Reports
Provision of CDISC: SDTM and ADaM compliant analysis datasets
Randomization support

Clinical trials data management

Case Report Form (CRF) design
CRF and data query tracking systems
Data processing (including double data entry)
Coding of diagnoses, AEs and drugs
Provision of CDISC ADaM compliant analysis datasets
Randomization support

Technology solutions

Greenline Trial Master is a comprehensive cloud-based eClinical platform built to improve the efficiency of conducting all clinical trials. Since 2020 Greenline Trial Master has been used in over 100 trials in all therapeutic areas and clinical phases.

Greenline Trial Master meets all applicable regulatory standards, including ICH GCP, 21 CFR part 11, HIPAA.

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