Biometrics And Data Management

Novotech’s Asia Pacific 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 Novotech 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 Novotech departments, they ensure seamless integration and interpretation of statistical elements into the reporting and discussion of clinical data.

Novotech’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

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

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

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

Novotech’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