Biostatistical Services

Our CRO-experienced team can provide high-quality, CDISC-compliant datasets, along with comprehensive biostatistical support and insightful analysis.

Unlock the potential of your clinical trials with our expert biostatistical services.

With our team’s extensive experience in clinical study design and data analysis, they are delivering high-quality, CDISC-compliant datasets along with insightful statistical analyses tailored to your project’s needs.

Biostatistical experience you can count on

Our biostatistical services are backed by a highly skilled team. Our Biostatisticians average over 12 years of industry experience, and our Statistical Programmers bring more than 9 years of expertise. This expert team also has broad therapeutic knowledge and have supported the clinical development process across all trial phases and designs.Because of our extensive experience, we are able to deliver exceptional results under tight timelines, leveraging our in-depth knowledge of programming languages like SAS. Our expertise empowers you throughout the entire clinical development journey, ensuring that your projects are efficient and effective.

Choose us for reliable and comprehensive biostatistical services that enhance the success of your clinical trials.

Why work with us?

All Phases

Experience across Phases I-IV, non-interventional and real-world studies, throughout all therapeutic areas

CDISC

CDISC conversion experience

13 13 Years average industry experience of Senior Biostatisticians and Statistical Programmers

Our services

Statistical consultancy
- Statistical input/review of study design and protocols
- Sample size calculations
- Randomisations
- Program-level statistical guidance
- Real-world data and analysis expertise
- Clinical Study Report (CSR) input/review
CDISC specification and programming
- SDTM and ADaM development
- High level of expertise and familiarity with CDISC standards
- eCRT package provision (define.xml, reviewer’s guide)
Legacy conversion to CDISC standards
- Conversion of study datasets to CDISC standards to support regulatory submission
- In-depth knowledge in the steps required to carefully map data, handle problematic data structures and unresolved data issues
SAP Writing and TFL Production
- Development of statistical analysis plans using in-depth knowledge and expertise
- Table, figure and listing shells/specifications development
- Production/QC/review of tables, figures and listings for interim and final study reporting
DSUR summary programming
- Annual reporting for DSURs
- Single or multiple studies
Independent QC of Programmed Deliverables
- QC/review service of available datasets/TFLs – including dual programming
- Support with validating quality and analysis decisions
- Independent/unbiased quality control
ISS/ISE Development
- Specialist knowledge in steps required to integrate multiple studies for reporting and submission
- Integrations at SDTM and/or ADaM level
- Statistical analyses supporting Integrated safety (ISS) and efficacy (ISE) summaries
Reporting for Safety Review Committees (SRCs)
- Specification and programming / review of outputs for SRCs
- Quick turnaround to support swift decision making
- Statistical expertise in escalation designs and approach
Independent DSMB/IDMC Support
- Independent Statisticians and Programmers to provide support for DSMB/IDMC reporting
- Development/review of DSMB/IDMC charter
- Development of TFL shells and/or DSMB/IDMC SAP
- Programming and review of TFLs
- Attendance at meetings