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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 i
5 key trends in the biologics and biosimilars market 2021
Overcoming the challenges of COVID-19
On-Demand Webinar: Shifting sands of Pharmacovigilance-Pivot, Maneuver, Breakout
Top 5 Innovations in Clinical Trials that are benefiting the Pharma Industry
Regulatory Support for Accelerated Drug Approvals
Innovative Trial Designs
Electronic Automation and Process optimization for First-Time-Right Submissions
7 Tech Enablers of new age Clinical Data Management
On-Demand Webinar: IDMP is Becoming Mandatory – A Roadmap to Compliance
Full Service Clinical Trial Support for a Global Multicenter Orphan Phase 3 Imaging Trial
Full Service Clinical Trial Support on patients with Persistent Post-Concussive Symptoms after Traumatic Brai
Full Service Clinical Trial Support to assess a Medical Device on Neurology Patients
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, 202
RWD/RWE – Introduction, Challenges, and Best Practices from a Programmer’s Perspective
qualityREADY® Analytics - Our robust Quality Intelligence Platform
A Strategic Journey to RIM Maturity - Implementing a RIM system for a global mid-sized biotechnology company
Future Ready Labeling – How to Thrive and Survive
Delivering Quality Insights with qualityREADY® for a global pharmaceutical company headquartered in APAC
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
Celebrating Women Empowerment – Featuring Sowmya Kaur
rimREADY - Innovative Technology to simplify RIM operations and enable accurate and timely submissions
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?
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
Maintaining Continuity of Clinical Research in the Era of COVID-19
India can Reshape Hybrid Clinical Trials
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
Enhancing the overall efficiency of global Regulatory Information Management
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
Achieving End-to-End PV Operations through Integrated Processes, Technology and Services
Delivering an End-to-End Regulatory Technology Solution that provides One Source of Truth
Operational approaches to evaluate the safety & efficacy of therapies in moderate to severe COVID-19 patients
R Programming in Clinical Trial Data Analysis
Disrupting the Clinical Research industry by merging trial software development and trial delivery
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
Clinical Trials viewed through a Manufacturing Lens
A Comprehensive QMS implementation on TrackWise for a top 10 pharma company in India
Strategic approaches to mitigate and manage non COVID-19 Clinical Trials during a Pandemic
Be compliant with DSCSA VRS Requirements with Navitas Life Sciences’ traceREADY
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?
Leveraging AI Based Platform and Analytics to Drive Successful Clinical Trials Outcomes
RIM Maturity: A Strategic Path to RIM Excellence A multi-dimension tool for building RIM Strategy
Transform your End-to-End Safety Operations for greater visibility and control by leveraging leading edge tec
Barriers Preventing Clinical Trial Software Development
Automation, Analytics and Artificial Intelligence (AI) – A Roadmap to NextGen Pharmacovigilance (PV) Transf
Leveraging Technology for Improved Outcomes across End-to-End Labeling
The next safety database upgrade – assessing impacts of E2b(R3)
ICH E6(R2) Readiness Assessment Framework helps you ensure compliance and transform your clinical operations
RIM Maturity Model: A strategic path to next-generation Regulatory Information Management
EudraVigilance - Handling the far reaching and diverse impact on changes to EV system
Navitas Life Sciences On-Demand Webinar Clinical & Regulatory Data Convergence: Increasing Enterprise Value
The building blocks of successful outcomes in Data-Driven Clinical Trials
Regulatory Information Management Just how far have we progressed?
The safety database in a pharma company – tactical considerations for delivering on compliance and efficien
Integrated Clinical Data Services, Clinical Data Management, Biostatistics and Medical Writing
E2E labeling – Achieving Global Consistency
Digitally transformed pharmacovigilance Why we need it and why it will take a while to become reality
CDISC SDTM Conversion, a Case Study in Perfection
PV Organisations Reimagined - Roadmap to transforming into a strategic PV organisation
Organizing your Global Labeling Function – what is the optimal structure?
PSP Management
The Challenge of Regulatory Information Management
Biostatistics and Statistical Programming - Partnering to accelerate success in clinical submissions
RIM Maturity Pathway – achieving your RIM goals using the RIM Maturity Model
Succeeding with Revised GVP Module IX: Seizing the Opportunity and Managing the Challenges
Clinical Data Management Flexible Clinical Data Services Enables a Successful IND Submission
Medical Writing
The Case for Labeling Outsourcing Is labeling the next area ripe for outsourcing?
PV Safety Benefit Risk Management Optimisation and Integration
Is labeling the next area ripe for outsourcing?
Getting Inspection Ready
Data Standardization Achieving Successful Submissions while Overcoming Complexity
Will you be ready to comply with DSCSA Verified Router Services
Navitas Life Sciences On-Demand Webinar EU FMD Compliance: Are You READY?
Labeling Organization – Simplicity or Specialism?
WhitePaper - Preparing for successful IDMP submission – an opportunity to gain real business benefit and be
PV Affiliates Risk Assessment
End-to-End Labeling Tracking Tools in Action
Risk Minimisation Through the Affiliate Lens
Discovering Value with Terminated Drugs and Studies
Building a Regulatory Information Enterprise Architecture
GVP Module IX update – Impact beyond borders
Webinar series on ICH E6 GCP compliance Introducing ICH compliant RBM to your Clinical Trials Webinar
End-to-End Labeling through an Optimized Process and Technology Implementation
Client Case Study - End-to-End (E2E) Labeling
Implementing TrackWise Quality Management Systems and Document Management for Global Excellence
Client Case Study - End-to-End (E2E) Labeling
A Regulatory Outsourcing Partnership for Submission Management, Publishing and Product License Support
A unique view of sustainable IDMP solutions
Case Study - Overhauling Pharmacovigilance Processes, Governance, and Technology
Case Study - End To End PV Optimization
Ensuring SDEA Oversight and Harmonization in an M&A Context
WhitePaper - The Case for Streamlined Consulting Complaints Management in Medical Devices
Diabetes Infographic and the 14 Treatments that will Come Off Patent by 2025
Respiratory Diseases and their Treatments that will Soon Come Off Patent
Inhalation Studies
EU FMD Compliance Made Easy with traceREADY EU FMD Compliance Made Easy with trace READY
Transform Your Safety Operations With Our End-to-End Pharmacovigilance (PV) Services
Successfully rescuing an Oncology Phase III trial for a global biopharmaceutical company
Clinical Data Services
Driving successful outcomes for Clinical Trials by providing trial oversight and near-realtime insights
Regulatory Services
Accelerators for faster and better implementations of Argus Safety
Simplify and strengthen your End-to-End labeling process with Labeling Assessment Express ™
End-to-End Bioavailability & Bioequivalence Services Enabling the First-to-Market Advantage
Methods Library
Euglycemic Clamp Studies
Clinical GCP Rapid Assessment
Clinical Data Management
Data Standardization
Biostatistics & Statistical Programming
Non Interventional Studies
pharma READY – Product Suite to ensure robust process optimization for First-Time-Right Submissions
Navitas' Offering of Oracle Argus on cloud based multi-tenant platform
Pathways for successful UDI implementation
Drug meets Device Successfully integrating Combination Products and Medical Devices into a pharmaceutica
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