Top Pharma Articles of 2023: Year in review

Clinical Research Organizations (CROs) play a significant role in clinical research and in transforming healthcare. Ranging from catering to specialized niche pharmaceutical companies to expansive global pharma companies, CROs serve as the driving force behind the journey of new drugs and medical devices from conception to FDA approval. CRO’s invaluable service by relieving drug sponsors of the need for in-house staff maintenance, allow them to focus on the core aspects of their innovations.

Among the largest contract research organizations, Navitas Life Sciences has emerged as a beacon of expertise and influence, leaving an indelible mark on the discourse and strategies within the industry. With a proud legacy spanning over 30 years, Navitas Life Sciences has spearheaded more than 600 clinical trials across a diverse spectrum of therapeutic areas, including in Oncology. OneClinical^® Analytics platform, a technological advancement enhances clinical trial efficiency by providing comprehensive oversight and unlocking key data insights.

As we bid farewell to 2023, this blog focuses on the big pharma articles that provide a glimpse into the cutting-edge advancements and groundbreaking strategies via pharma research articles and pharma review articles that will continue to propel the industry forward.

Navitas Life Sciences: Top Articles of 2023

1. 4 Strategies for Data Managers to Modernize and Transform Clinical Data Science

Our article ‘4 Strategies for Data Managers to Modernize and Transform Clinical Data Science’ by Dr Yun Lu, Chief Operating Officer and VP Data Management and Standards, and Elisa Ahmanson, Associate Vice President - Clinical Operations, looks at why it is important to track the changing requirements of data managers, anticipating future trends, to understand the factors that could spearhead innovation and efficiency. The article also includes 4 Strategies for Data Managers to Advance Data Science.

2.Novel Approaches Revolutionize Cancer Care

In this interesting article, published in PharmaFocus Asia, Sowmya Kaur, Dr Atul Gupta, and Dr Akash Gadgade look at how the pursuit for effective treatment modalities for cancer rides on sustained efforts with catalyzed adoption of technological advancements that surpass traditional paradigms. The article shines a spotlight on innovations in early phase oncology trials design and in clinical drug development, moving towards the implementation of adaptive designs and master protocols, are encouraged by regulatory agencies. Early phase adaptive clinical trial success story continues to inspire and influence the development of next generation trial designs in oncology as well as other therapeutic areas. flexible methodologies in adaptive clinical trial design are critical enablers of scientific breakthroughs that will aid in faster pace of drug development. Such developments not only influence the trajectory of oncology clinical trial designs but extends its impact to other therapeutic areas as well.

3. Exploring Potential FHIRs and E-labelling for Market Access

In ‘Exploring the potential of FHIRs and e-labelling,’ Mallikarjun R , Murali Prasaanth Babu, Priya Arunachalam and Palli Nomuganesh discuss the potential benefits of using Fast Healthcare Interoperability Resources (FHIRs) and electronic labelling (e-labelling) in the healthcare industry. FHIR Fast Healthcare Interoperability Resources allow fast to build REST based APIs, and are revolutionising the way healthcare providers, patients, and vendors share and access sensitive data. As an emerging health data exchange standard, FHIRs allow for secure storage and easy-to-understand data communication.

4. The emergence of RWD and RWE – are they an alternative to RCT?

Authored by Venkatesan Balu, Associate Director of Global Data Science, Navitas Life Sciences, the article explores the accumulating evidence from real world data (RWD), what real world data is and advances in technology that suggest that hybrid clinical studies that utilize RWD have the potential to support regulatory decisions in the absence of randomized controlled trial (RCT) data.

5. Preparing for the New Era: A Guide to Transitioning Clinical Trials to CTIS Regulation in the EU

Read the insightful article on transitioning to the CTIS portal authored by Bhuvaneswari Sivaraman, Regulatory SME, Regulatory Operations, Ragini Tushar Bhandari, Senior Manager, Regulatory Operations and Velkumar Kuzhandhaipandian, Senior Manager, Regulatory Operations to find out about Clinical Trial Information System, the vital prerequisites for accessing the Clinical Trials Information System portal, key benefits of utilizing the CTIS portal and getting authorization right.

6. How Biostatisticians Use advances in Technology to Reshape Risk Based Monitoring

This article written by Venkatesan Balu, Associate Director, Global Data Sciences, Navitas Life Sciences sheds light on the role of Biostatisticians in the emerging field of Risk Based Monitoring. The increased frequency of offsite monitoring in clinical sites has resulted in a growing demand for the implementation of Risk Based Monitoring (RBM) and Centralized Monitoring (CM). In order to establish a strong centralized monitoring team, it is essential to include biostatisticians and statistical programmers who may not have been traditionally involved in onsite monitoring but play crucial roles in ensuring robust monitoring processes.

7. Spontaneous Reporting System for Adverse Drug Reactions in Germany

Dr Philipp Hofmann examines the implementation and success of a spontaneous reporting system for adverse drug reactions in Germany. The article showcases how this system leads to more efficient identification and management of adverse events with reduced resource requirements, offering insights for enhanced pharmacovigilance in a Germany cro.

8. Key Takeaways from The FDA Guidance On DCTs

This article by Dr Atul Gupta and Dr Akash Gadgade summarizes key insights and strategies from the FDA guidance on Decentralized Clinical Trials (DCTs), illustrating how companies can conduct trials with increased efficiency and reduced costs. The article emphasizes the pivotal role of technology and Decentralized Clinical Trial approaches in achieving more meaningful results in clinical research.

9. Navigating Data Integrity for Generic Drug Approvals

This article provides insights into data integrity challenges in the context of generic drug approvals, this article offers practical solutions and best practices. Navitas Life Sciences showcases case studies of successful generic drug approvals achieved through streamlined data management processes.

In 2023, Navitas Life Sciences continues to lead the way in providing thought-provoking pharma articles that shape the future of healthcare. As we look forward, these insights will undoubtedly serve as a compass for navigating the ever-evolving landscape of life sciences.

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