Clinical Trial Methodology, Study Design & Biostatistics Consulting

Offering expertise in biostatistics

By offering tailored solutions with a strong focus on quality, our clients can keep a track on timelines, and costs are kept to a minimum. Our statisticians provide statistical support along the full development cycle of the drug, from early development to post-marketing studies, across a wide variety of therapeutic areas. Our biostatistics consulting group provides support for study protocols, including study design, sample size calculation, and defining study objectives and endpoints.

Providing extensive support in complex statistical areas

Our statistical consulting group provides support for complex statistical methodology and innovative designs, handling of missing data, regulatory guidance for strategic development and support at meetings with global regulators. Venn Life Sciences also offers extensive support for Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) meetings, including support in charter’s development and provision of unblinded statistician.

Venn Life Sciences offers support in:

Study Design & Methodology Services

Study Design and protocol support
- Statistical methodology and study design
- Implementation of estimands (ICH E9(R1) guideline)
- Complex/innovative designs
- Sample-size calculations
- Simulations
- Advisory committees
Regulatory support
- Special Protocol Advice/Scientific Advice/Pre-IND meetings
- MAA (Marketing Authorisation Application) submissions
- Answers to regulatory authority questions
Training
- Internal
- External

Statistical Services

Statistical Part of the protocol writing
SAP (Statistical Analysis Plan) writing
Programming:
- ADS (Analysis Datasets)
- TFLs (Table, Figures and Listings)
- Source Version control System used to track all changes
- Quality Control (Plan, Documentation)
- CDISC package (ADaM datasets, define.xml, ADRG (Analysis Data Reviewer Guide), P21 validation report)
TFL deliverables
Statistical reports/CSR support

Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC)

Oversight of independent statistician:
- Elaborate unblinded results for DSMBs/DMCs or interim analysis
- Guarantee the unblinded posture/state of the statistical team
Statistical inputs for DMC/DSMB charter writing
TFLs preparation
Meeting’s attendance