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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 for a Global Multicenter Orphan Phase 3 Imaging Trial

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 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

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?

End-to-End Bioavailability & Bioequivalence Services Enabling the First-to-Market Advantage

Driving successful outcomes for Clinical Trials by providing trial oversight and near-realtime insights

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

Biostatistics & Statistical Programming

Data Standardization

Clinical Data Management

Clinical Data Services

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

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

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

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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)...

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WhitePaper - Preparing for successful IDMP submission – an opportunity to gain real business benefit and be...

Accelerators for faster and better implementations of Argus Safety

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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

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EU FMD Compliance Made Easy with traceREADY EU FMD Compliance Made Easy with trace READY

Pathways for successful UDI implementation

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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

Case Study - 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

Medical Writing

Integrated Clinical Data Services, Clinical Data Management, Biostatistics and 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

A unique view of sustainable IDMP solutions

Building a Regulatory Information Enterprise Architecture

Drug meets Device Successfully integrating Combination Products and Medical Devices into a...

Ensuring SDEA Oversight and Harmonization in an M&A Context

PV Affiliates Risk Assessment

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