World Health Day 2023: Spotlight on our Services that Support Transformation in Healthcare

7^th April is World Health Day and it also marks the 75^th Anniversary of the World Health Organization, an important occasion that reminds us of the need to prioritize health and well-being. At Navitas Life Sciences, we are committed to advancing healthcare by offering a suite of services for pharmaceutical and biotechnology companies, including end-to-end clinical trial services, regulatory and pharmacovigilance services to ensure safety for patients around the world.

Navitas Life Sciences supports small to large pharma, biotech and devices companies, generics manufacturers, and U.S Federal agencies like Centers for Disease Control and Prevention (CDC) and The U.S. Department of Defense (DoD), delivering platform-driven full-service Clinical, Regulatory and Safety solutions and services.

Clinical Research

The biopharmaceutical sector is currently experiencing significant changes that are moving towards patient-centric models to deliver better outcomes and value-based approaches. With technology serving as a catalyst, companies are using artificial intelligence (AI) and machine learning (ML) to tackle various difficulties associated with managing and conducting clinical trials. At Navitas Life Sciences, we provide a powerful blend of life sciences knowledge and technological expertise to assist you in managing your clinical trials effectively. Our comprehensive and innovative services cater to your needs and overcome the obstacles faced during clinical trials, resulting in improved outcomes across the drug development process.

A technology led full-service CRO, Navitas Life Sciences has 30+ years of rich experience across 600+ phase I-IV clinical trials, 20+ therapeutic areas, including Oncology. Our trial excellence is enhanced by our proprietary OneClinical Analytics platform, providing oversight and key data insights.

Article

Novel approaches in early phase Oncology trials to revolutionize Cancer care

Our article ‘Novel approaches in early phase Oncology trials to revolutionize Cancer care’ by Sowmya Kaur, Dr. Atul Gupta, and Dr. Akash Gadgade was published in the 50th issue of PharmaFocus Asia magazine.

Read the article to find out how the pursuit for effective treatment modalities for cancer rides on sustained efforts with catalyzed adoption of technological advancements that surpass traditional paradigms.

Published by PharmaFocus Asia

March 2023 | Issue 50 | Pages 44 - 47

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Clinical Registries Support

We have over 30 years of expertise in managing early through late phase clinical trials and registries & other observational studies. Our clients span the range of US Federal Government institutes and non-profits.

COMPREHENSIVE SERVICES TO MEET ALL YOUR REGISTRY DESIGN & IMPLEMENTATION NEEDS

• Common Data Element (CDE) and metadata driven Registry eSolution implementation
• Development of Pilot Registry with core and focused data elements and data sets
• Creation of data collection forms
• Development of patient reported outcomes module
• Clinical registries aid in gaining real world evidence

Case Study

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

The Parkinson’s Foundation (PF) works towards improving care for people with Parkinson’s disease (PD) and people at risk of developing PD and advancing research to find a cure. The foundation has a multi-center community and offers genetic testing to create a genetic data and sample repository. This registry program also provides genetic counselling to the participants. The PF required the services of an experienced clinical research organization as the Registry Coordinating Center supporting their large genetic registry program.

Read the Case Study and learn how we

• Streamlined process and support to over 90 sites
• Provided efficient and effective data management and quality control
• Ensured successful Integration of the clinical data of nearly 2000 patients with the genetic data
• Shared data sets with The Global Parkinson’s Genetics Program (GP2), National Institute on Aging (NIA) and Michael J Fox Foundation

Read our Case Study

Clinical Data Support

Our expert-driven Statistical Programming, Biostatistics, and Data Management services support successful clinical trial outcomes. Our clinical data management expertise supports all clinical trial phases throughout the drug development life cycle.

Innovation, technology, and expertise can support data management in clinical trials by improving data collection, storage, and analysis. This can lead to more efficient and accurate clinical trials, which can ultimately improve patient outcomes.

Article

4 Strategies for Data Managers to Modernize and Transform Clinical Data Science

Our article written by Dr.Yun Lu, Chief Operating Officer and VP Data Management and Standards, and Elisa Ahmanson, Associate Vice President - Clinical Operations, article published by Applied Clinical Trials looks at

• Why it is important to track the changing requirements of data manager
• Anticipating future trends
• Highlighting factors that could spearhead innovation and efficiency

Published by Applied Clinical Trials

06 January 2023

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Article

The Emergence of RWD and RWE – Are they an alternative to RCT?

Our article by Venkatesan Balu, Associate Director, Global Data Sciences, Navitas Life Sciences published in Express Pharma, discusses the use of Real World Data(RWD) and Real World Evidence(RWE) in clinical trials.

Read the article and get insights on

• Real World Data (RWD) – Implementation and Strategy
• Inclusion of RWD in Hybrid Clinical Trials
• Barriers to Utilizing RWE in Clinical Trials
• Navigating the Regulatory Framework
• Statistical tools Used to Collect RWE

Published by Express Pharma

April 2023

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Regulatory Affairs

Strategic Partnerships to optimize your Regulatory Processes, drive First-Time-Right Submissions, and enable Life Cycle Management

With today’s ever evolving regulatory environment placing increased emphasis on Patient Safety, we successfully partner with our clients to navigate the landscape and ensure Patient Safety. With a rich legacy of experience and expertise, we serve as trusted advisors and provide tailored solutions grounded in industry best practices.

Navitas Life Sciences has 132000+ eCTD Submissions, 28000+ NeES Submissions, 40000+ Paper Submissions, 160+ Regulatory Professionals, 200+ Customers, and 5 Technologies to its credit to provide fit-for-purpose and cost-effective solutions for small, mid-sized, and large pharma companies.

In our End-to-End Regulatory Services support, you'll find key strategy-strengthening and data-backed insights that include:

• Benchmark insights into the latest industry trends from our Proprietary Regulatory Networks
• Vast expertise and global 24x7 delivery model to ensure proactive quality, compliance, and First Time Right submissions
• A rich legacy of experience, aiding us in serving as trusted advisors to provide tailored solutions grounded in industry best practices
• Strong experience in Medical Writing and Submission for IND / NDA / ANDA
• Expertise in building an experienced global team to support clients to manage products in a cost effective manner.

Article

Exploring the potential of FHIRs and e-labelling

Our article by Mallikarjun R , Murali Prasaanth Babu, Priya Arunachalam and Palli Nomuganesh published in Pharmaphorum discusses the potential benefits of using Fast Healthcare Interoperability Resources (FHIRs) and electronic labelling (e-labelling) in the healthcare industry.

Read the article and get insights on

• How FHIR is different from other interoperability standards
• How healthcare systems benefit from FHIRs
• How an FHIR is linked to electronic Product Information (ePI)
• Why there is a need for end-to-end ePI support

Published by Pharmaphorum

March 2023

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Pharmacovigilance Support

Navitas Life Sciences has been at the forefront of new developments in Pharmacovigilance for more than 30 years. Our Consulting Team has defined and implemented PV processes, governance practices and even organizations in more than 300 Life Sciences companies.

Many of the top 100 biopharma companies are members of pvnet or pvconnect, our Safety Networks. They benefit from round-the-year insights on operational performance, compliance and the latest trends highlighted during our forums, and frequent interactions with our experts.

This wealth of experience and PV knowledge combined with our Technology capabilities is utilized across all our PV services and solutions.

Industry Leading Networks

Celebrating 20 years of Harnessing Emerging Trends in our industry leading Pharmacovigilance and Regulatory networks

The unique perspectives and topics discussed in our networks have helped in examining new ways of optimizing processes in the biopharma industry, providing access to an independent community that delivers peer-to-peer interaction with regular opportunities to exchange insights, compare performance, and debate strategies to tackle the latest issues.

The foundation for the networks was laid in 2001, when pvnet® was founded by industry professionals with shared common challenges. The radically innovative strategies discussed helped in building the family of networks to 8, now boasting 110+ member companies, many of whom have remained loyal members who continuously benefit from the competent and consistent strategies shared.

Industry Survey

Effects of the COVID-19 pandemic on PV Strategy, Systems, and Processes of large, medium, and small companies – An Industry Survey

Our article, Effects of the COVID-19 pandemic on Pharmacovigilance strategy, systems, and processes of large, medium, and small companies – An industry survey, has been published in Volume 44 of the Clinical Therapeutics Journal.

The original research article, co-authored by subject matter experts from Navitas Life Sciences, Tufts University School of Medicine, Pfizer, and ResMed Limited presents the findings of a survey completed as part of Navitas Life Sciences’ industry leading pvnet and pvconnect networks.

Published by Clinical Therapeutics

September 2022

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At Navitas Life Sciences, we are committed to conducting clinical trials that are efficient, cost-effective, and of high quality. Our end-to-end services are designed to help sponsors navigate the complex drug development and regulatory process and bring safe and effective medicines and therapies to patients around the world. On this World Health Day, we reaffirm our commitment to advancing healthcare and contributing to a healthier world.

To learn more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.