partner with clinvia

Clinvia CDM services

At Clinvia, we provide end-to-end services that empower faster decision-making, improve data quality, and simplify operations. We help our partners bring therapies to market with confidence and agility.

Clinical Data
Management Services

End-to-End Clinical Data Management


Clinvia manages clinical studies of all sizes, from Phase I–IV, as part of our FSP model or standalone projects. Whether for Pharma, Biotech, or Medical Devices, our clinical data managers are ready. We support Medidata RAVE, VEEVA, CLARIO, MEDDRIO, and other leading EDC systems.

EDC Designing and Setup

At Clinvia, our “Quality First” approach ensures attention to detail from study startup to closure. We understand the critical role of data management in meeting key milestones. Our skilled, high-performing project and functional teams are ready to deliver the clinical data management support you need.

EDC Designing and Setup

Data Validation and reconciliation
Lab Data Management
Quality Control – Sample QC
Database Soft & Hard Lock
Delivery of Clean Data Files, Database Release & Documentation of Clinical Data Management Report

Data Quality & Regulatory Compliance


Data quality and regulatory compliance are critical to every trial. Our team performs rigorous checks from entry to database lock, ensuring audit readiness and transparency. We align with FDA, EMA, and ICH guidelines to manage risk, maintain documentation, and support successful, validated submissions.

Biostatistics and
Programming

FSP & Standalone Biostatistics Support


Clinvia offers expert Biometrics services, supporting clinical studies from Phase I–IV through FSP models or standalone projects. Our experienced statisticians and programmers assist with all types of regulatory submissions and approvals.

Biometric Capabilities

SAP
Sample Size calculation
Study Design
CDISC SDTM/ADaM
Interim Analysis
DSUR
PSUR
BLA Filings
Exploratory Analysis
Pinnacle 21
eCTD document
EDURACT

Data Quality & Regulatory Compliance


Maintaining data quality and compliance is essential in every trial. Our Biometrics consultants apply rigorous checks from data entry to database lock. With a strong “Quality” focus, we ensure audit readiness and data transparency from the start.

Moreover…


As regulatory standards evolve, your data strategy must keep pace. Clinvia ensures alignment with FDA, EMA, and ICH guidelines, using practices that meet current expectations. We help manage risk, ensure proper documentation, and support successful submissions with complete, validated data.

Let’s build your data-driven Clinical Research engine with our CDM and Biostatistics expertise!

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