Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
Biostatistics & Statistical Programming
From statistical analysis planning through TLF generation, we provide biostatistics support for robust analyses, prepared to regulatory standards, in your clinical trials.
Comprehensive Biostatistics Support
We support your organization across statistical activities—from SAP development and randomization through final analysis and TLF programming. Our experienced biostatisticians integrate with your team to deliver high-quality statistical analyses prepared to regulatory standards.
As your biostatistics support partner, we bring technical expertise in SAS/R programming, CDISC standards knowledge, and a working understanding of regulatory requirements for statistical reporting.
Our approach
How We Support Your Statistical Analyses
- 01
Planning & Setup
We support SAP development, determine analysis approaches, and create ADaM specifications aligned with your protocol objectives.
- 02
Randomization & Interim
We generate randomization schedules, support interim analyses, and provide DSMB-ready reports as needed throughout the trial.
- 03
Final Analysis
Upon database lock, we execute statistical analyses per SAP, create validated ADaM datasets, and generate publication-quality TLFs.
- 04
Reporting & Submission
We prepare CSR statistical sections, create define.xml, and deliver submission-ready analysis datasets with full documentation.
Deliverables
What You Receive
Statistical Analysis Plans
Comprehensive SAPs aligned with protocol objectives and regulatory requirements.
Randomization Schedules
Validated randomization with stratification factors and proper documentation.
ADaM Datasets
CDISC-conformant analysis datasets with define.xml and full traceability.
TLFs
Publication-quality tables, listings, and figures prepared to regulatory standards.
CSR Sections
Statistical methods and results sections ready for inclusion in clinical study reports.
Validation Reports
Documentation of independent programming QC, supporting analysis accuracy.
Why Prequel
The Prequel Advantage
CDISC Expertise
Experience with ADaM standards and regulatory requirements for submission-ready datasets.
Ready at Database Lock
Analysis workflows are prepared before lock, so programming can start as soon as the database is locked.
SAS & R Proficiency
Flexibility to work in your preferred statistical environment with experienced programmers.
Quality Assurance
Independent programming QC built into our deliverables, supporting accuracy and regulatory compliance.
When you need us
Common Scenarios
Database Lock Approaching
Need statistical programming resources to execute analyses and generate TLFs immediately post-lock.
CDISC Submission
Require ADaM datasets for regulatory submission but lack in-house CDISC expertise.
Interim Analysis
Scheduled interim analysis requires rapid statistical analysis and DSMB report preparation.
Resource Capacity
Statistical programming team at capacity with ongoing trials and cannot accommodate new analyses.
Related support services
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
Ready to Strengthen Your Statistical Analyses?
Let’s discuss how our biostatistics support can strengthen your analyses, from SAP through to submission-ready outputs.