Advanced Analytics & Biostatistics Services
CPVIA provides comprehensive biostatistics, engineering data analysis, and validation programming services across the entire product development lifecycle—spanning protocol and test development, study design, statistical analysis, and global regulatory submission. Our trained and competent professionals are well-equipped to provide insightful analyses and system reporting that enables clients to draw clear inferences and make well-informed, data-driven decisions.
"Our focus is to add maximum value to our partners through deep expertise in standard statistical reporting, open-source programming tools, and highly regulated data environments."
Our team is dedicated to providing services in compliance with current industry standards and global regulatory guidelines. GxP-compliant infrastructures, 21 CFR Part 11-compliant systems, and well-documented SOPs form the backbone of our project implementation. We stay up to date with evolving industry standards, shifts in the regulatory environment, and rapid advancements in technology and applications.
The wide repertoire of projects we have delivered spans multiple complex domains and therapeutic areas across product lifecycles. Our focus on software automation, script optimization, and the ability to customize solutions tailored to client-specific engineering and clinical environments makes us a trusted partner with global innovators.
With a strong global presence and a team of expert biostatisticians, data scientists, and specialized systems programmers, CPVIA is uniquely positioned to provide a wide range of analysis and programming services where timely delivery and absolute accuracy are of paramount importance.
Statistical Input to Protocol, Study & Test Design
Phase I–IV | Endpoint Design | Engineering Parameters
Scientific and
technical guidance integrated at the protocol and engineering test development stage—defining
endpoints, estimands, system performance criteria, and methodologies aligned with international
regulatory requirements.
Sample Size Estimation & Power Calculations
All Phases | Adaptive Designs | Engineering Verification
Rigorous power
calculations and sample size customization models for all testing phases—from early feasibility
and dose-escalation through confirmatory pivotal trials and hardware/software validation.
Randomization & Stratification Schedules
Stratified Blocks | Minimization | IWRS Ready
Generation and validation of
stratified block, minimization, and adaptive randomization schedules with full audit-trail
documentation, IWRS/IRT-compatible outputs, and strict regulatory compliance.
Review of Data Collection Forms & Specifications
CDASH Aligned | Data Architecture | Specification Review
Statistical and
technical review of Case Report Forms (CRFs) and Data Management Plans to ensure data collection
requirements perfectly align with downstream analysis needs and industry standards.
Statistical Analysis Plans (SAP) & Mock-up Shells
Pre-specified Criteria | Reporting Templates
Comprehensive SAP authoring
aligned with regulatory guidelines, including annotated mock-up Tables, Figures, and Listings
(TFL) shells, covering primary, secondary, and exploratory outcomes.
Analysis of Safety, Efficacy & Performance Data
CSR & Technical Files | ISS / ISE | FDA & EMA
Production-ready TLFs,
statistical summaries, and narratives for Clinical Study Reports (CSR) and technical
files—accurately summarizing safety, efficacy, and system performance data with required
regulatory submission packages.
Advanced Programming — Standardized Datasets & TLFs
CDISC SDTM / ADaM | Engineering Formats
Validated programming for
CDISC-compliant SDTM and ADaM dataset creation, engineering dataset mapping, and comprehensive
TLF generation using dual-programmer validation and strict quality standards.
Design & Deployment of System-Level Reusable Code
Macro Libraries | Open-Source Packages | Automation-First
Development of
standardized, reusable macro libraries and package scripts for scalable output
generation—reducing turnaround times, minimizing manual error, and enforcing consistent
standards across all outputs.
PK/PD Analysis & Modeling
NCA | Phoenix WinNonlin | R / SAS Workflows
Non-compartmental and
compartmental pharmacokinetic and pharmacodynamic analysis—supporting PK, PK/PD, and NDA
submission requirements with Phoenix WinNonlin, SAS, or R deliverables.
Integrated Safety, Efficacy & Performance Analysis
ISS / ISE Submissions | Pooled Data Integration
Pooled cross-study analyses
for Integrated Summaries of Safety and Efficacy (ISS/ISE)—supporting NDA, BLA, MAA, and device
submission requirements with full data integration, CIOMS tables, and subject-level datasets.
Bioavailability/Bioequivalence (BA/BE) & Meta-Analysis
Bioequivalence | ANOVA Models | Crossover Designs
Bioavailability and
bioequivalence analyses using FDA and EMA-compliant ANOVA models, alongside systematic
meta-analyses supporting product labeling, engineering benchmarks, and regulatory
decision-making.
CDISC Implementation & Data Standardization
SDTM Mapping | ADaM Architecture | Define.xml
End-to-end CDISC standards
design—SDTM domain mapping, ADaM architecture, define.xml generation, and Pinnacle 21
validation—ensuring submission-readiness.
Safety Monitoring, Interim Analytics & Scientific Support
DMC/DSMB Support | Adaptive Designs | Manuscripts
Structured and unblinded
interim analysis, Data Monitoring Committee support, adaptive design programming, and technical
writing support for regulatory manuscripts, congress abstracts, and peer-reviewed publications.
Patient & System Profiles / Safety Narratives
Individual Listings | FDA / EMA Specifications
Customized data listings and
individual medical/technical narratives for safety reviews—precisely formatted to FDA, EMA, and
device regulatory submission specifications.
Statistical & Technical Report Writing
End-to-end report authoring—summaries, methodology sections, efficacy/performance narratives, and regulatory submission-ready documentation packages aligned with global regulatory guidelines.