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 team provides a high-quality statistical framework to translate the scientific context to clinical practice findings which is essential for achieving research success.

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.  Collaborating closely with other Greenline Clinical Research departments, they ensure seamless integration and interpretation of statistical elements into the reporting and discussion of clinical data.

Greenline Clinical Research’s key biostatistics services include:

• 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

Greenline Clinical Research leverages high-quality, cost-effective solutions to ensure successful management and delivery of clinical trial data. Greenline Clinical Research’s primary goal in data management is to provide clean, locked databases in an optimal format, on time and to budget.

To achieve this, Greenline Clinical Research offers clients leading industry tools for data management, including Medidata RAVE® or Greenline Trail Master® for eCRFs, providing a tailored approach to suit every client’s needs, budget and clinical site logistics.

Greenline Clinical Research’s research data management services can be customized to deliver a high-quality, cost-effective solution compliant with the most rigorous regulatory standards.

Greenline Clinical Research’s key clinical trials data management services include:

• 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

“Clinical trial designs are getting increasingly complex and the North America region is now established as a preferred destination for drug development. This means that biotech companies are looking for more scalable solutions especially with regards to data quality and biometrics.

The Biometrics team has grown to about 100 staff throughout Canada and North America and we make a point a retaining and growing our best talents. This means we now have the firepower to handle the full Biometric activity of global trials and not only of regional studies. This makes a huge difference for our clients looking at tapping into the benefits of each region for their global trials.”

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 Trail Master has been used in over 100 trials in all therapeutic areas and clinical phases.

Created by industry professionals with decades of experience, Greenline Trail Master blends innovation with design to simplify your workday. Our mission is to be at the forefront of eClinical innovation by developing new, smarter ways to help all our clients succeed. Greenline Trail Master meets all applicable regulatory standards, including ICH GCP, 21 CFR part 11, HIPAA.