Biostatistics

Designed for Quality and Efficiency

BIOSTATISTICS AND SAS® PROGRAMMING

At SCOPE, biostatistics is an integral part of every clinical and post-marketing study across a wide range of therapeutic areas.

From study planning to delivery of the clinical study report, our expert biostatisticians are involved through every phase of clinical drug development.

By using best suited clinical trial designs, best-practice randomization methods, validated industry-standard systems, data quality assessments, timely statistical analysis and by following all applicable guidelines, SCOPE delivers clinical trial results that are scientifically accurate, validated and reproducible.

Through close cooperation with our project managers, data managers, medical monitors and writers, our biostatistics team develops flexible solutions to fit your needs – always working together with your goal in mind.

See how we can support your study:

Biostatistical Services

Statistical advice on study design, choice of endpoints and protocol preparation
Sample size planning and power calculations
Input in CRF / eCRF design
Statistical analysis planning (SAP)
Randomization, including provision of randomization schedule with treatment information and random code envelopes Interim analyses
Statistical analysis of clinical data and validation using SAS^®
Support to ISS / ISE (Integrated Summary of Safety and Efficacy) and DSMB (Data and Safety Monitoring Boards)
Preparation (programming) of statistical Tables Listings and Figures
Result evaluation and interpretation
Input to Clinical trial report
Data pooling and Meta-analysis
Statistical and strategic consulting including:
- Strategic Product Development Consulting
- Statistical input for briefing documents
- Statistical support for dossier preparation
- Performing post-hoc analyses to support response to questions
- Representation at Regulatory / Reimbursement Authorities
- Advisory Meeting support
Publication support
Clinical trial result posting in EudraCT

SAS® Programming

CDISC standards implementation
- SDTM and ADaM dataset production
- Data mapping across different standards
- Programming specifications for SDTM and ADaM datasets
- Creation of define.xml and SAS xpt data sets; annotated CRF for SDTM data sets
Risk based validation, double-independent programming
Data pooling and development of Integrated ISS/ISE datasets
Tables, listings and figures (TLFs) programming
Subject profiles and medical review listing programming
(Blinded) Data review tables and listings preparation
Preparation of validated data / XML files for trial results reporting to EudraCT database

Data mining and exploratory data analysis

Systematic statistical programming to detect potential signals / patterns across different studies
Signal detection on product or compound basis / analysis data from different trials
Statistical graphics and interactive data visualization

Clinical Data Management

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Medical Writing