From study design consultation to submission-ready CDISC packages, our biostatisticians and statistical programmers collaborate to deliver peer-reviewed, validated outputs.
Sound statistical decisions depend on more than running the numbers. Our biostatisticians and programmers provide expert statistical support across all phases of clinical research and therapeutic areas, helping sponsors make informed decisions from study design through regulatory submission.
Our Services include:
Study design consultation and sample size calculations
Randomization plans and schedules
Statistical analysis plans (SAPs) and Table, Figure and Listing (TFL) shells
Interim safety, pharmacokinetic (PK), pharmacodynamic (PD), efficacy and exploratory analyses
Interim and Final TFLs for study reporting
CDISC-compliant SDTM and ADaM datasets
eSubmission packages, including Annotated CRF (aCRF), define.xml, Clinical Study Data Reviewer’s Guide (CSDRG), and Analysis Data Reviewer’s Guide (ADRG)
Every analysis is designed to be valid, relevant and aligned with study objectives – producing actionable results and conclusions that withstand scientific and regulatory scrutiny.
Experience snapshot
0 +
eSubmission packages supported
0 +
Statistical Analysis Plans written
0 +
Interim, topline and final analyses completed
0 +
Years combined leadership experience
Our biostatistics approach
01
Planning stage
Our biostatisticians are involved from study design forward. At the planning stage, they provide design consultation, sample size calculations and review the relevant data management documentation to align the analysis strategy and data structure before the study starts.
02
Statistical analysis plan
As the protocol takes shape, the team generates randomization schedules, develops the statistical analysis plan and TFL shells, which define how the data will be analyzed and reported. Establishing these elements early reduces rework later and supports on-time reporting.
03
Conduct and database lock
The team performs planned analyses, including interim, safety, PK, PD, efficacy and exploratory analyses, and prepares the tables, figures and listings used for study reporting. Expedited interim and topline analyses can support dose escalation and other time-sensitive decisions.
04
Datasets and outputs
Throughout the study, our biostatisticians collaborate closely with the statistical programming team to produce validated outputs, including CDISC-compliant SDTM and ADaM datasets and complete eSubmission packages, so the deliverables are ready for submission.
Our biostatistics and programming leadership
Our biostatisticians and statistical programmers work as one integrated team. Biostatisticians define the analyses, while programmers build and validate the datasets and outputs. Pairing these functions means the experts who design the analysis and those who produce the results stay aligned from the SAP through final delivery. The teams are led by:
Statistical programming produces SDTM and ADaM datasets and associated outputs that conform with CDISC standards. eSubmission packages are prepared and validated using Pinnacle 21 Enterprise version, which checks deliverables against submission requirements.
The team works within DVCR’s integrated, cloud-based technology environment, including our eSource/Clinic Workflow Automation System and Electronic Data Capture (EDC) systems. These secure platforms use industry-standard encryption and built-in redundancy to support data protection, reliability and accessibility. Integrated platforms enable real-time data capture, validated audit trails, study metrics and give sponsors secure visibility into study progress.
Quality, standards and compliance
Quality is built into every deliverable.
Datasets and outputs
Datasets and outputs are peer-reviewed and independently validated before release, so the results sponsors rely on are checked by a second set of qualified eyes.
Regulatory compliance
Building to CDISC standards and validating eSubmission packages with Pinnacle 21 Enterprise supports regulatory compliance and ensures a smooth submission process.
Collaboration
Close collaboration with data management helps maintain data integrity and consistency from the study database through the analysis datasets. The team also partners with medical writing during clinical study report (CSR) development. They also partner with biostatisticians participating in the review to ensure study results are summarized accurately and consistently.
Connected across the full study lifecycle
Biostatistics and programming play a central role in transforming study data into actionable results. Working closely with Data Management, the PK/PD team, Medical Writing and Project Management, the team helps ensure data flows efficiently from collection through analysis and reporting.
Featured study
Challenge
A sponsor needed emerging safety and PK data to support a time-sensitive dose-escalation decision while protecting study blinding and keeping the broader program on schedule.
Approach
Our biostatistics and statistical programming team worked with data management and project leadership to define a fit-for-purpose interim analysis, establish the appropriate data cut point and cleaning requirements, and prioritize decision-critical outputs. Designated unblinded personnel generated the interim analyses while the broader study team remained blinded.
Outcome
The staged approach provided the sponsor with timely, decision-ready results while maintaining study integrity and allowing comprehensive, validated analyses and reporting to continue as planned.
Talk to a team that takes your study from design to submission-ready data.
Our biostatisticians and statistical programmers work together on study design, analysis plans and validated CDISC-compliant deliverables, so your analyses are sound and your submission package is ready.
