Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success

A unique partnership model drives 30% efficiency gains in Regulatory Operations

Elevating Global PV and MICC Operations through Integrated Excellence

End to End Clinical Trial Execution with Successful Market Authorization for a Global Biopharma in Metabolic Disorders

Celebrating Innovation and Impact in Clinical Trials

Accelerating Safety Data Migration and Analytics for a Global Mid-Sized Pharma

Parkinson’s Foundation’s PD GENERation Study: Insights from Leading Experts

Rescuing a Critical Statistical Programming Project for a Leading Biopharma Company

The Windsor Framework: Insights on the regulatory shift for medicines

Regulatory Partner Support for Acquired Oncology Product Portfolio

Transforming Global Labeling 

Elevate your Data Governance

Transforming Data into Innovation

Seamless implementation of an enterprise end-to-end labeling solution

Transforming Regulatory Compliance – A journey to sustainable excellence

Pioneering the Future – Crafting and implementing a transformative PV vision and strategy

Transforming PV – Crafting a future-ready PV affiliate model for a global pharma leader

Exploring the Impact of Virtual Clinical Trials on Patient Care

Insights on the UK's MHRA International Recognition Procedure

GenAI in PV and Regulatory Affairs

labelREADY – AI-Powered Global and Local Labeling Traceability

De-Mystifying R Programming in Clinical Trials

Automation of literature search and review

Comprehensive Medical Writing Services

Successful End-to-End Clinical Trial, Risk Management, Pharmacokinetic Monitoring Support and USFDA Audits for a Global Pharma’s Study on Renal Cell Carcinoma

Successful Registry and Data Coordinating Center Support for Parkinson’s Foundation’s Parkinson’s Disease GENEration Registry

Regulatory Strategy - Key Considerations to expedite Marketing Approvals

Inhalation Studies

Methods Library

Key Takeaways From The FDA Guidance On DCTs

Biostatistics and Statistical Programming

Clinical Data Management

Spontaneous Reporting System for Adverse Drug Reactions in Germany

How Biostatisticians Use advances in Technology to Reshape Risk Based Monitoring

The emergence of RWD and RWE - are they an alternative to RCT?

Exploring the potential of FHIRs and e-labelling

Novel Approaches in Early Phase Oncology Trials to Revolutionize Cancer Care

Centralized Medical Data Review at the core of Risk Based Monitoring

On-Demand Webinar: Technology Enabled Centralized Data Surveillance in Risk Based Monitoring

Adding value to government’s mandated QR code on all APIs

Innovations in Labeling

Effects of the COVID-19 pandemic on PV strategy, systems, and processes

Dynamic Digital Labels – from local pilot to regional reality

Managing a complex PV engagement by leveraging safetyREADY

On-Demand Webinar: Digital registry platforms - Considerations for EHR/EDC Integration

Adaptive design for a global Study for a First-in-Class Therapy for Critical Covid-19 Patients

Delivering End-to-End Global Signal Activity Services to a mid-sized global pharma company

Successfully leveraging automation for expedited end-to-end ICSR processing and submissions

It’s now time for your OPDP Submissions to be FDA compliant – are you ready?

On Demand Webinar: Enhance your Data Science toolkit with open source tools - How R can create efficiencies in data review and insight

Top 5 Innovations in Clinical Trials for the Pharmaceutical Industry

Regulatory Support for Accelerated Drug Approvals

7 Tech Enablers of new age Clinical Data Management

On-Demand Webinar: IDMP is Becoming Mandatory – A Roadmap to Compliance

Prospective Full Service Medical Device Clinical Trial on Patients with Persistent Post-Concussive Symptoms after Traumatic Brain Injury

Full Service Clinical Trial Operation, Monitoring, Safety and Data Management support for a First-in-Human Phase I Dose Escalation Oncology Study

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

Future Ready Labeling – How to Thrive and Survive

A Strategic Journey to RIM Maturity - Implementing a RIM System for a global mid-sized biotechnology company in the US

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

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

Drug Data Coding Conventions – the Coding Process and Challenges

Rapid optimization and upgrade of PV business intelligence technology for improved analytics and insights

Successfully managing ongoing and new Oncology studies throughout the COVID-19 pandemic

Phase I Double Blind Safety, Tolerability, and PK Evaluation of a COVID-19 Therapy in Healthy Volunteers

Leading from the Front – Featuring Sowmya Kaur

rimREADY – Innovative technology to simplify RIM operations and enable accurate and timely submissions

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

Nuclear Point for Macro-Sized Clinical Research and Development

Moving Ahead with Intelligent Virtual Clinical Trials

Partnering to deliver End-to-End Labeling Services to support Labeling and Artwork Management

Enhancing the overall efficiency of global Regulatory Information Management

Regulatory Services

Highly Efficient Safety and Efficacy Evaluation of COVID-19 Therapies

Oncology Phase III Biosimilar Trial in India

Regulations to enable safe, effective, & high quality AI, ML & Digital Solutions in Drug Development

Delivering Publishing and Submission Management Services for a mid-sized global biotechnology company

Operational approaches to evaluate the safety & efficacy of therapies in moderate to severe COVID-19 patients

pharmaREADY - Product suite to ensure robust process optimization for First-Time-Right Submissions

Enabling process excellence for Quality Management and Regulatory Affairs Operations with TrackWise

Strategic approaches to mitigate and manage non COVID-19 Clinical Trials during a Pandemic

Integrated PV Services

Can Pharmacovigilance meet the COVID-19 Challenge?

Managing the Operational Challenges of COVID-19 Clinical Trials 

Non Interventional Studies

Barriers Preventing Clinical Trial Software Development

Will you be ready to comply with DSCSA Verified Router Services 

Labeling Organization – Simplicity or Specialism?

Clinical Trials viewed through a Manufacturing Lens

Client Case Study - End-to-End (E2E) Labeling

Leveraging Technology for Improved Outcomes across End-to-End Labeling

Navitas' Offering of Oracle Argus on cloud based multi-tenant platform

rimnet

Accelerators for faster and better implementations of Argus Safety

pvnet

Navitas Life Sciences On-Demand Webinar  EU FMD Compliance: Are You READY? 

labelnet

Pathways for successful UDI implementation

RIM Maturity: A Strategic Path to RIM Excellence - A multidimension tool for building RIM strategy

RIM Maturity Model: A strategic path to next-generation  Regulatory Information Management

Organizing your Global Labeling Function – what is the optimal structure?

The building blocks of successful outcomes in Data-Driven Clinical Trials

Is labeling the next area ripe for outsourcing?

CDISC Data Standardization Challenges and Solutions

Integrated Clinical Data Services, Clinical Data Management, Biostatistics, and Medical Writing

Clinical Data Management - Flexible Clinical Data Services Enables a Successful IND Submission

The Case for Labeling Outsourcing - Is labeling the next area ripe for outsourcing

A unique view of sustainable IDMP solutions

Drug meets Device - Successfully integrating combination products and medical devices

PV Affiliates Risk Assessment

PSP Management

GVP Module IX update – Impact beyond borders

Discovering Value with Terminated Drugs and Studies

The next safety database upgrade – assessing impacts of E2b(R3)

Risk Minimization Through the Affiliate Lens

PV Organisations Reimagined - Roadmap to transforming into a strategic PV organisation

End-to-End Labeling Tracking Tools in Action

The Challenge of Regulatory Information Management