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On-Demand Webinar: Maximize Clinical Data Interoperability & Automation to Accelerate your Clinical Trials...
How Biostatisticians Use advances in Technology to Reshape Risk Based Monitoring
Preparing for the New Era: A Guide to Transitioning Clinical Trials to CTIS Regulation in the EU Bhuvaneswari...
The emergence of RWD and RWE – are they an alternative to RCT?
Navigating combination products for patient safety organizations
Exploring the potential of FHIRs and e-labelling
An interview with Dr. Yun Lu
Novel approaches in early phase Oncology trials to revolutionize Cancer care
How does Clinical Data Management adapt to Decentralized Clinical Trials?
Centralized Medical Data Review at the core of Risk Based Monitoring – the path to success
Successful submission of a complex NDA for a Pneumococcal conjugate vaccine for the NHRA in Bahrain
On-Demand Webinar: Technology Enabled Centralized Data Surveillance in Risk Based Monitoring
4 Strategies for Data Managers to Modernize and Transform Clinical Data Science
Adding value to the government’s mandated QR code on all APIs Article
Providing End-to-End IND Regulatory and Medical Writing Services
Innovations for Labeling
Webcast: Are you prepared for mandatory QR codes on APIs?
Effects of the COVID-19 pandemic on PV Strategy, Systems, and Processes of large, medium, and small companies...
Total Iron and Transferrin bound Iron assay for Iron based oral & injection formulations and elemental...
On-Demand Webinar: Innovation and Optimization in Early Phase Oncology Studies: Opportunity for speed,...
Dynamic Digital Labels – From local pilots to regional reality
Meta-data Driven Data Coordinating Center Support for Parkinson’s Foundation PD GENEration Registry
Managing a complex PV engagement by leveraging safetyREADY to deliver process optimization
Intelligent and Unified Data Analytics and Aggregation for 5 Clinical Trials, from 3 CROs, and 3 EDC...
Current Trends in Pharmacogenomics that will shape Clinical Trials
On-Demand Webinar: Digital registry platforms - Considerations for EHR/EDC Integration
On-Demand Webinar: Dont Treat Your Registry like your Clinical Trials
Successful Registry and Data Coordinating Center Support for Parkinson’s Foundation’s Parkinson’s...
Adaptive design for a global Study for a First-in-Class Therapy for Critical Covid-19 Patient
Total and Transferrin Bound Iron Assay for Iron Sucrose Formulations – Application in Regulated Bioanalysis
Virtual Clinical Trials – A Renaissance in the Making
Delivering End-to-End Global Signal Activity Services to a mid-sized global pharma company
Achieving complete Inspection Readiness in PV through integrated Processes, Technology, and Services
Methods Library
Successfully leveraging automation for expedited end-to-end ICSR processing and submissions
On-Demand Webinar: Risk Mitigation in Gene Therapy Clinical Trials Development
It’s now time for your OPDP Submissions to be FDA Compliant – Are you Ready?
Providing a Single Source of Truth
On Demand Webinar: Enhance your Data Science toolkit with open source tools - How R can create efficiencies...
5 key trends in the biologics and biosimilars market 2021
Overcoming the challenges of COVID-19
Top 5 Innovations in Clinical Trials that are benefiting the Pharma Industry
On-Demand Webinar: Shifting sands of Pharmacovigilance-Pivot, Maneuver, Breakout
Regulatory Support for Accelerated Drug Approvals
Innovative Trial Designs
7 Tech Enablers of new age Clinical Data Management
Electronic Automation and Process optimization for First-Time-Right Submissions
On-Demand Webinar: IDMP is Becoming Mandatory – A Roadmap to Compliance
Full Service Clinical Trial Support on patients with Persistent Post-Concussive Symptoms after Traumatic...
Full Service Clinical Trial Support to assess a Medical Device on Neurology Patients
Full Service Clinical Trial Support for a Global Multicenter Orphan Phase 3 Imaging Trial
Full Service Clinical Trial Support for a First-in-Human Phase I Dose Escalation Oncology Study
NextGen PV – A Digitalized Future Presented at Oracle Health Sciences Connect North America | 24 March, 2021
RWD/RWE – Introduction, Challenges, and Best Practices from a Programmer’s Perspective
qualityREADY® Analytics - Our robust Quality Intelligence Platform
Future Ready Labeling – How to Thrive and Survive
Delivering Quality Insights with qualityREADY® for a global pharmaceutical company headquartered in APAC
A Strategic Journey to RIM Maturity - Implementing a RIM system for a global mid-sized biotechnology company...
Clinical Data Standards in the era of AI, ML, and Digital Transformation
FDA UDI vs. EU MDR Regulations - Consideration of the Regulations and Implications for EU Labeling
How can Dispensers combat counterfeiting?
Statistical Programming support for an urgent ISS for a top 20 global pharmaceutical company
On-Demand Webinar: Enabling Digital Quality Transformation
Drug Data Coding Conventions – the Coding Process and Challenges
A Global FSP helping you to meet the challenges of data requirements in clinical trials
Rapid optimization and upgrade of PV business intelligence technology for improved analytics and insights
Complex Safety Data Migration of over 200,000 cases from a homegrown system to Oracle Argus
Successfully managing ongoing and new Oncology studies throughout the COVID-19 pandemic
Brexit and Pharmacovigilance – where may pharmaceutical companies go?
Phase I Double Blind Safety, Tolerability and PK Evaluation of a COVID-19 Therapy in Healthy Volunteers
Implementing Oracle Argus to support AEs & Technical Product Complaints processing for a device manufacturer
Leading from the Front – Featuring Sowmya Kaur
rimREADY - Innovative Technology to simplify RIM operations and enable accurate and timely submissions
Celebrating Women Empowerment – Featuring Sowmya Kaur
Configuring Oracle Argus to meet Device and Combination Product Regulatory Requirements
Clinical Data Standards in the era of AI, ML, and digital transformation
Are your Regulatory Submissions Brexit Ready?
Driving successful outcomes for Clinical Trials by providing trial oversight and near-realtime insights
End-to-End Bioavailability & Bioequivalence Services Enabling the First-to-Market Advantage
Nuclear Point for Macro-Sized Clinical Research and Development
traceREADY A NextGen Mobility Platform Providing Insights from the ‘Point of Action’
Moving Ahead with Intelligent Virtual Clinical Trials
Implementing a Regulatory Technology Solution to support DMS, eCTD, and SPL needs
Partnering to deliver End-to-End Labeling Services to support Labeling and Artwork Management
A collaborative partnership providing resources for Regulatory Affairs Technical and Publishing
Enhancing the overall efficiency of global Regulatory Information Management
Maintaining Continuity of Clinical Research in the Era of COVID-19
India can Reshape Hybrid Clinical Trials
Regulatory Services
A Regulatory Outsourcing Partnership for Submission Management, Publishing and Product License Support
Highly Efficient Safety and Efficacy Evaluation of COVID-19 Therapies in Moderate to Severe Patients
Optimized Safety and Efficacy Clinical Trials for a Combination Therapy on Moderate COVID-19 Patients
Successfully rescuing an Oncology Phase III trial for a global biopharmaceutical company
Clinical Data Services
Data Standardization
Clinical Data Management
Biostatistics & Statistical Programming
Providing Regulatory Affairs support to manage Life Cycle Maintenance Submissions for a mid-sized biopharma
Regulations to enable safe, effective, & high-quality AI, ML & Digital Solutions in Drug Development
Driving accelerated compliance and delivering First-Time-Right Submissions with pharma READY
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
Delivering an End-to-End Regulatory Technology Solution that provides One Source of Truth
R Programming in Clinical Trial Data Analysis
Can your Regulatory Technology Drive Accelerated Compliance and Deliver First-Time-Right Submissions?
QMS implementation on TrackWise Digital for the US operations of a top 10 pharma company in India
Enabling process excellence for Quality Management and Regulatory Affairs Operations with TrackWise
A Comprehensive QMS implementation on TrackWise for a top 10 pharma company in India
Inhalation Studies
Strategic approaches to mitigate and manage non COVID-19 Clinical Trials during a Pandemic
Delivering cost effective End-to-End Pharmacovigilance Services from Clinical Trials to Post-Marketing
Delivering Integrated PV Services and Technology to ensure Compliance
Reducing costs, increasing efficiency and compliance while improving Patient Safety
Can Pharmacovigilance meet the COVID-19 Challenge? A checklist approach to PV Business Continuity
Enhancing the overall efficiency of global Regulatory Information Management
Managing the Operational Challenges of COVID-19 Clinical Trials
Are you prepared for the new EU Medical Device Regulation (MDR) requirements?
Non Interventional Studies
pvindia
Barriers Preventing Clinical Trial Software Development
Transform your End-to-End Safety Operations for greater visibility and control by leveraging leading edge...
Will you be ready to comply with DSCSA Verified Router Services
Be compliant with DSCSA VRS Requirements with Navitas Life Sciences’ traceREADY
Respiratory Diseases and their Treatments that will Soon Come Off Patent
Diabetes Infographic and the 14 Treatments that will Come Off Patent by 2025
Labeling Organization – Simplicity or Specialism?
Disrupting the Clinical Research industry by merging trial software development and trial delivery
Clinical Trials viewed through a Manufacturing Lens
Client Case Study - End-to-End (E2E) Labeling
Client Case Study - End-to-End (E2E) Labeling
End-to-End Labeling through an Optimized Process and Technology Implementation
Leveraging Technology for Improved Outcomes across End-to-End Labeling
Implementing TrackWise Quality Management Systems and Document Management for Global Excellence
Navitas' Offering of Oracle Argus on cloud based multi-tenant platform
Automation, Analytics and Artificial Intelligence (AI) – A Roadmap to NextGen Pharmacovigilance (PV)...
rimnet
WhitePaper - Preparing for successful IDMP submission – an opportunity to gain real business benefit and be...
Accelerators for faster and better implementations of Argus Safety
pvnet
pvconnect
Euglycemic Clamp Studies
Leveraging AI Based Platform and Analytics to Drive Successful Clinical Trials Outcomes
Navitas Life Sciences On-Demand Webinar EU FMD Compliance: Are You READY?
labelconnect
labelnet
EU FMD Compliance Made Easy with traceREADY EU FMD Compliance Made Easy with trace READY
Pathways for successful UDI implementation
pvtech
RIM Maturity: A Strategic Path to RIM Excellence A multi-dimension tool for building RIM Strategy
Digitally transformed pharmacovigilance Why we need it and why it will take a while to become reality
RIM Maturity Model: A strategic path to next-generation Regulatory Information Management
Regulatory Information Management Just how far have we progressed?
Organizing your Global Labeling Function – what is the optimal structure?
Case Study - End To End PV Optimization
The building blocks of successful outcomes in Data-Driven Clinical Trials
Overhauling Pharmacovigilance Processes, Governance, and Technology
Is labeling the next area ripe for outsourcing?
RIM Maturity Pathway – achieving your RIM goals using the RIM Maturity Model
CDISC SDTM Conversion, a Case Study in Perfection
Integrated Clinical Data Services, Clinical Data Management, Biostatistics and Medical Writing
Medical Writing
Data Standardization Achieving Successful Submissions while Overcoming Complexity
Clinical Data Management Flexible Clinical Data Services Enables a Successful IND Submission
Biostatistics and Statistical Programming - Partnering to accelerate success in clinical submissions
The Case for Labeling Outsourcing Is labeling the next area ripe for outsourcing?
Succeeding with Revised GVP Module IX: Seizing the Opportunity and Managing the Challenges
Point of view - Building a Regulatory Information Enterprise Architecture
A unique view of sustainable IDMP solutions
Drug meets Device Successfully integrating Combination Products and Medical Devices into a...
PV Affiliates Risk Assessment
Ensuring SDEA Oversight and Harmonization in an M&A Context
EudraVigilance - Handling the far reaching and diverse impact on changes to EV system
PSP Management
PV Safety Benefit Risk Management Optimisation and Integration
GVP Module IX update – Impact beyond borders
Clinical GCP Rapid Assessment
Discovering Value with Terminated Drugs and Studies
The safety database in a pharma company – tactical considerations for delivering on compliance and...
The next safety database upgrade – assessing impacts of E2b(R3)
E2E labeling – Achieving Global Consistency
Risk Minimisation Through the Affiliate Lens
Simplify and strengthen your End-to-End labeling process with Labeling Assessment Express ™
PV Organisations Reimagined - Roadmap to transforming into a strategic PV organisation
Getting Inspection Ready
End-to-End Labeling Tracking Tools in Action
WhitePaper - The Case for Streamlined Consulting Complaints Management in Medical Devices
The Challenge of Regulatory Information Management
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