We drive better outcomes through drug development and beyond

Clinical
Research

Clinical research conducted with precision, expertise and near real time insights.

COVID-19
Clinical Trials

Wide-ranging expertise and experience to address safety and efficacy of new COVID-19 products.

Biologics &
Biosimilars Studies

We understand biosimilar and Biologics study complexities and ensure efficient trials

OneClinical

OneClinical helps you make informed decisions to maximize the success of your clinical trial.

Strategic Clinical
Consulting

Leverage domain knowledge and technology expertise to create immense value for your organization

Full Service
Clinical Trials

30 years of experience in conducting clinical trials has equipped us with the nuances to run successful trials

Non-interventional
Studies

Comprehensive NIS Capabilities to Meet Your Specific Needs, with ability to run trials ranging from 50 to 26,000+ patients

Clinical
Data Services

A CDISC registered solutions provider, we deliver high quality regulatory compliant clinical data

Generics
Development

Developing generics in terms of efficacy, safety and compliance

Inhalation
Studies

Expert capabilities and domain expertise that enable successful outcomes for respiratory disease clinical trials

Euglycemic
Clamp Studies

Right from phase I to phase IV, we support your organization from startup to closure, and beyond, with our regulatory insights and quality approach.

Bioavailability and
Bioequivalence Studies

Over 1100 BABE studies, 100 marketing authorization and 280 bioanalytical methods make us ideal partners

Data
Sciences

High quality Clinical Data FSP support

Biostatistics
Services

Expert biostatistics support for trial design, protocol development, data management, study monitoring, and more.

Statistical
Programming

Your reliable data scientists for key data insights that power better decisions to drive successful outcomes.

Pharmacokinetics/ Pharmacodynamics
Data Services

Our extensive PK/PD support will help you run efficient clinical trials following Global regulatory standards.

Data
Management

We ensure audit-ready clinical data documentation with quarterly reviews, personnel training and currency reviews.

CR Toolkit
SAS Macro Library

Our CR Toolkit™ enables you to work on study reports efficiently, helping you access your data accurately and consistently

Regulatory
Affairs

End-to-End regulatory services to ensure compliance

Regulatory
Strategy

Navigate the regulatory landscape with strategic oversight, industry benchmarks, and insights from our consulting team.

Regulatory
Process Consulting

We help standardize your compliance needs to minimize risk exposure, while also minimizing costs.

Regulatory
Industry Networks

17+ years of bringing Regulatory Affairs Leaders together to gain from practical solutions and challenges discussed.

End-to-End
Regulatory Services

Deliver First-Time-Right submissions, leveraging our 20 + years in regulatory experience in Pharma & Medical Devices companies.

Regulatory
Technology

Stellar applications for regulatory, content management, quality, track & trace, serialization and business intelligence.

Safety &
Pharmacovigilance

Proactive risk management for enhanced safety

Strategic
Safety Consulting

Our experienced consultants will help you with the right sourcing strategy and ensure global compliance

Safety
Industry networks

Our pharmacovigilance networks will help you gain key insights to help you manage your safety risks better.

End-to-End
Pharmacovigilance Services

Our expertise in full-service operations will help you improve your operational efficiency.

Pharmacovigilance
Technology

Leverage our pharmacovigilance technology to better manage patient safety and to drive successful outcomes.

Strategic
Consulting

Expert support to reach milestones with precision and expertise

Strategic
Clinical Consulting

Our global clinical consultants apply their extensive expertise and experience to ensure your clinical trial objectives are met through good clinical practices.

Strategic
Regulatory Consulting

Our subject matter experts with deep domain expertise will help provide personalized solutions for all your clinical trial needs.

Strategic
Safety Consulting

Our experienced consultants will help you with the right sourcing strategy and ensure global compliance

Industry
Networks

Platform to discuss trends, insights, and future solutions

pvnet

A network for Heads of Safety of Top 30 Life science companies; invests in thought leadership to help shape future practices

pvconnect

A network for Heads of Safety of mid-sized life science companies with both general portfolios and those with a specific focus

pvtech

A network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments

pvindia

A network for Heads of Safety of Indian Life Science companies & multi-nationals with a presence in the Indian market

rimnet

Develop best practices and leading-edge solutions for Regulatory Information Management

labelnet

A network for labeling professionals, focused on developing best practices for End-to-End labeling compliance, enhancing operational efficiency and excellence, and creating value-adding labeling

labelconnect

A network for labeling professionals, focused on developing best practices for End-to-End labeling compliance, enhancing operational efficiency and excellence, and creating value-adding labeling

labeltech

A network focused on exploring E2E labeling technologies to improve processes and increase business value for regulatory or labeling IT professionals or business leads

cmonet

The Network for Chief Medical Officers

clinicalnet

Coming soon! A network for Heads of Clinical Operations, focused on sharing best practice to define excellence in delivery of clinical trials

Highlights of our work

Keynote Presentation

RWD/RWE – Introduction, Challenges, and Best Practices from a Programmer’s Perspective

Brochure

qualityREADY® Analytics - Our robust Quality Intelligence Platform

Case Study

A Strategic Journey to RIM Maturity - Implementing a RIM system for a global mid-sized biotechnology company

Article

Future Ready Labeling – How to Thrive and Survive

Case Study

Delivering Quality Insights with qualityREADY® for a global pharmaceutical company headquartered in APAC

Keynote Presentation

Clinical Data Standards in the era of AI, ML, and Digital Transformation

Article

FDA UDI vs. EU MDR Regulations - Consideration of the Regulations and Implications for EU Labeling

Article

How can Dispensers combat counterfeiting?

Case Study

Statistical Programming support for an urgent ISS for a top 20 global pharmaceutical company

Upcoming Events

Jun

Virtual

labeltech Forum - Spring

Date: 22 June, 2021
Venue: Virtual

More Events...

Jun

Virtual

rimnet Forum - Spring

Date: 24 June, 2021
Venue: Virtual

More Events...

Jul

Virtual

Live Webinar | IDMP is Becoming Mandatory – A Road...

Date: 01 July, 2021 | 10:00 – 11:00 EST | 16:00 – 17:00 CEST | 19:30 – 20:30 IST
Venue: Virtual

More Events...

Live Webinar IDMP is Becoming Mandatory – A Roadmap to Compliance

Better Outcomes for Clinical Research

COVID-19 Clinical Trials

We drive better outcomes through drug development and beyond

Clinical Research

COVID-19 Clinical Trials

Biologics & Biosimilars Studies

OneClinical

Strategic Clinical Consulting

Full ServiceClinical Trials

Non-interventionalStudies

ClinicalData Services

Generics Development

Inhalation Studies

Euglycemic Clamp Studies

Bioavailability and Bioequivalence Studies

Data Sciences

Biostatistics Services

Statistical Programming

Pharmacokinetics/ Pharmacodynamics Data Services

Data Management

CR Toolkit SAS Macro Library

Regulatory Affairs

Regulatory Strategy

Regulatory Process Consulting

RegulatoryIndustry Networks

End-to-End Regulatory Services

Regulatory Technology

Safety &Pharmacovigilance

StrategicSafety Consulting

Safety Industry networks

End-to-EndPharmacovigilance Services

PharmacovigilanceTechnology

Strategic Consulting

StrategicClinical Consulting

Strategic Regulatory Consulting

StrategicSafety Consulting

Industry Networks

pvnet

pvconnect

pvtech

pvindia

rimnet

labelnet

labelconnect

labeltech

cmonet

clinicalnet

Highlights of our work

Keynote Presentation

Brochure

Case Study

Article

Case Study

Keynote Presentation

Article

Article

Case Study

Upcoming Events

labeltech Forum - Spring

rimnet Forum - Spring

Live Webinar | IDMP is Becoming Mandatory – A Road...

Who We Are

Live Webinar
IDMP is Becoming Mandatory – A Roadmap to Compliance

COVID-19
Clinical Trials

Clinical
Research

COVID-19
Clinical Trials

Biologics &
Biosimilars Studies

Strategic Clinical
Consulting

Full Service
Clinical Trials

Non-interventional
Studies

Clinical
Data Services

Generics
Development

Inhalation
Studies

Euglycemic
Clamp Studies

Bioavailability and
Bioequivalence Studies

Data
Sciences

Biostatistics
Services

Statistical
Programming

Pharmacokinetics/ Pharmacodynamics
Data Services

Data
Management

CR Toolkit
SAS Macro Library

Regulatory
Affairs

Regulatory
Strategy

Regulatory
Process Consulting

Regulatory
Industry Networks

End-to-End
Regulatory Services

Regulatory
Technology

Safety &
Pharmacovigilance

Strategic
Safety Consulting

Safety
Industry networks

End-to-End
Pharmacovigilance Services

Pharmacovigilance
Technology

Strategic
Consulting

Strategic
Clinical Consulting

Strategic
Regulatory Consulting

Strategic
Safety Consulting

Industry
Networks