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175+

YEARS COMBINED EXPERIENCE

3+

Global Regions

6

CORE SERVICE AREAS

11+

THERAPEUTIC AREAS

CPVIA Team
ABOUT CPVIA

Clinical Data Analytics, Biostatistics
& Medical Device Solutions

CPVIA is headquartered in Hyderabad, India — a globally recognized clinical research hub. We specialize in end-to-end biometrics and medical device services for pharmaceutical, biotechnology, CRO, and medical device companies worldwide.

"Bringing all biometrics and medical device expertise in clinical research under one platform."

Our mission is to deliver a one-stop solution for clinical development — with measurable value, precision execution, and regulatory excellence at every stage.

Global Pharma & CRO Support
Regulatory Submission Expertise
Innovation & Automation Driven
Experienced Biometrics & Medical Device Team
SAS, R & Python Expert Teams
100% Regulatory Success Rate
CORE SERVICES

Comprehensive Service Portfolio

End-to-end clinical research solutions designed for pharmaceutical, biotech, and CRO partners across all therapeutic areas and study phases.

WHY CHOOSE US

The CPVIA Advantage

Built on deep domain expertise, innovation, and an unwavering
commitment to quality delivery for global clinical research.

01

Global Biometrics & Medical Device Expertise

Combined 175+ years of industry experience spanning Phase I–IV studies across pharma, biotech, CROs, and medical device companies worldwide.

02

Innovation-Driven Delivery

Automation, AI-assisted workflows, and cutting-edge tooling that accelerate timelines while maintaining regulatory quality standards.

03

100% Regulatory Success

Flawless FDA & EMA submission track record. Deep expertise in CDISC, define.xml, SDRG/ADRG, and Pinnacle21 compliance validation.

04

Scalable Flex Teams

FSP engagement model with <10% attrition rate, rapid ramp-up, and dedicated biometrics & medical device professionals aligned to your study needs.

05

One-Stop Biometrics & Medical Device Platform

From clinical data standards to advanced analytics, CPVIA unifies all biometrics and medical device disciplines in a single, seamlessly integrated partnership model.

06

Global Delivery Network

Hyderabad-based COE with 24/7 delivery capability supporting US, UK, and European pharma and CRO clients across multiple time zones.

DOMAIN AUTHORITY

Our Expertise
in Clinical Biometrics & Medical Devices

CPVIA delivers world-class biometrics and medical device consulting through deep clinical domain authority, regulatory precision, and scalable enterprise delivery — from Phase I to global submission.

100%
REGULATORY SUCCESS RATE
175+
YEARS COMBINED EXPERTISE
50+
GLOBAL STUDIES DELIVERED
CORE DOMAIN

Clinical Trial &
Medical Device Support

End-to-end biometrics and medical device support across Phase I-IV trials. Expert biostatisticians, statistical programmers, and data managers working as one integrated unit from protocol to regulatory package.

Phase I-IV Coverage SAP Development ISS / ISE CSR Support
REGULATORY EXCELLENCE

Regulatory Submission
Expertise

Flawless NDA, BLA, and MAA submission packages. Deep mastery of FDA, EMA, and ICH standards with a 100% regulatory success track record across all submitted studies.

FDA / EMA NDA / BLA / MAA Define.xml SDRG / ADRG
DATA STANDARDS

CDISC-Compliant
Clinical Data Standards

Rigorous SDTM and ADaM implementation with Pinnacle21 validation. CDISC-certified expertise ensuring data packages meet the highest regulatory and operational standards globally.

SDTM Implementation ADaM Datasets Pinnacle21 Data Review

End-to-End Clinical Trial Delivery Workflow

1

Protocol &
SAP Review

Study Design

2

CDISC Data
Standards Setup

SDTM / ADaM

3

Statistical
Programming

TLFs · PK/PD

4

Safety & Efficacy
Analysis

ISS · ISE · CSR

5

QC & RBQM
Validation

Pinnacle21 · P21

6

Regulatory
Submission

FDA · EMA · ICH

GLOBAL PARTNERS
TRUSTED BY GLOBAL PHARMA & CRO PARTNERS
US Pharma Partners
UK CRO Leaders
Global Biotech
Medical Devices
Phase I-IV Studies
FDA Submissions
EMA Compliance
US Pharma Partners
UK CRO Leaders
Global Biotech
Medical Devices
Phase I-IV Studies
FDA Submissions
EMA Compliance
PARTNER WITH CPVIA

Looking For A Reliable| Partner?

CONTACT OUR TEAM