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Navitas Life Sciences’ Top 10 Blogs for 2022
Our top 10 blogs provide an aerial view of trends that were considered big in early 2022, some of the events that we were associated with and unique solutions that we continue to provide to enhance clinical trial efficiency.
Here is the list of top 10 blogs for 2022
1. Clinical Trials Trends for 2022 that you need to Know: This blog looked at some of the interesting trends to look out for in 2022, across services.
Srinivasan HR,
Chief Executive Officer,
Navitas Life Sciences
The Great Healthcare Acceleration
"The past couple of years saw a massive change in the way clinical trials were run and in the need for improved healthcare. Technology-led innovation has seen an exponential uptake, with McKinsey estimating that between $350 billion to $410 billion in Annual value can be created by utilizing such innovation to provide individual care. Clinical trial protocols have been quick to imbibe these innovations with oximeters, e-Consent forms, and tablets used for data collection. According to Global Data, a dramatic 93% increase in the uptake of decentralized clinical trials is expected in 2022, when compared with numbers in 2020.
Apart from COVID-19 vaccines and therapeutics, 2022 will witness clinical trials that study the use of monoclonal antibodies, CRISPR-based gene therapy, and even oncolytic viruses for multiple conditions including cancer. Diabetes, cardiovascular disease as well respiratory diseases are among the conditions that are expected to be most studied in 2022.
Navitas Life Sciences’ futuristic approach to clinical trial management enabled investments in technological innovation over several years, spearheading effective data management and near-real-time information-led decision making. Our vast experience and expertise across 20+ therapeutic areas and stringent adherence to protocols have garnered repeated engagements with leading pharmaceutical companies and a conclusive “without any observations for discussion” post remote record review by US-FDA."
2. How Navitas Life Sciences is attracting more women to pursue a career in supporting Global Public Health: According to a McKinsey report, nearly half of the degrees earned in science and engineering are by women. However, they constitute less than 20% of people involved in such fields. At Navitas Life Sciences, we provide a great platform for the right talent to excel. It is heartening that 42% of the Navitas Life Sciences team are female. This blog provided insihts on how Navitas Life Sciences provides the right platform for women to transition to a career in science.
“My father had his first heart attack when I was 13 and when I was 17 he had a 10 hour open heart surgery at a time when there were only 6 physicians in the country performing open heart surgeries. From then on, I was always interested in medicine but didn’t think I had the academic "chops" to succeed and I didn’t have anyone to encourage me. I was working as an office manager in a neurology office when the PI urged me to train as a study coordinator and that was it, I was hooked. Almost 30 years later I’ve had a wonderful career.”
Betsy Knight
Senior Clinical Research Associate; Clinical Research Manager
“I always wanted to be a scientist because there is a finite delight to compare to that of discovery. Science involves in every aspect of our lives. As a female scientist, I can explore the world with a new approach, make fascinating discoveries and develop scientific innovations that improve the lives of others, and I am proud of it”.
Greeshma Bhaskaran
Manager - Clinical Laboratory
3. Navitas Data Sciences will be at the PHUSE India Autumn Single Day Event: Navitas Data Sciences, a part of Navitas Life Sciences, was a media sponsor for the upcoming PHUSE India Autumn Single Day Event held on 17 September 2022. PHUSE is a Global Healthcare Data Science Community where ideas, tools, and standards around data, statistical, and reporting technologies are shared.
Shrishaila Patil, Senior Vice President, Navitas Data Sciences, has been nominated as PHUSE India's Single Day Event Lead. Shrishaila and our Associate Manager and Statistical Programmer, Ram Mohan Konda, were at the event to share their unique insights. This blog included a short interview to understand more about their roles and to shine a light on their experiences.
Appreciation for Navitas Data Sciences
“The studies have been finalized and I wanted to send a note of appreciation to the US team. The team did a tremendous job working through a number of milestones over the past 16 months. Through Navitas Data Sciences’ excellent leadership, the final submission deliverables were finalized. A special thank you to the team for doing a fantastic job critically reviewing data issues during the development of the SDTM and ADaM. The source data was especially challenging for these trials, but the team prevailed!!! Thank you.”Associate Director, Biostatistics Programming -
Top 50 US Pharmaceutical Company
4. Key Insights on Maintaining Digital Resilience and Data Security: Data Security is about managing risks and about coping with evolving needs, strategizing effectively for optimal efficiency. The coronavirus pandemic resulted in massive changes in how people worked, and to ensure business continuity, there was a need to embed security considerations while ensuring digital resilience to maintain the pace of innovation and for the decentralized nature of working.
Navitas Life Sciences leveraged its vast investment in the right technology and expertise to put together cybersecurity and digitization initiatives to strengthen its operations, during the pandemic and beyond.
This blog included an in depth discussion with Mr. S. Maharajan, Associate Vice President IT Infrastructure, Navitas Life Sciences, who helmed the digital transformation at Navitas Life Sciences, ensuring cybersecurity and business continuity, even during uncertain times.
5. Importance of Quality Assurance in Clinical Trials: Quality is at the core of our efforts, and we adapt effectively to changing needs and conditions.
In this blog, we met with Anand. C. Rao, Vice President Quality Assurance at Navitas Life Sciences to get more insights about quality practices at Navitas Life Sciences and learn how to embark on a journey towards optimum quality. Anand received the “Top Most Quality Leader Award” 2022 from World Quality Congress and Awards in recognition of his sustained commitment to ensuring quality at every stage in our organization.
6. A closer look at the USFDA review of our generics studies: This blog focussed on the remote review of our Generics Business Unit’s Bioequivalence Studies conducted by The U.S Food and Drug Administration (FDA). The review was conducted bywith 4 inspectors from their US office (Office of study integrity and surveillance, Division of Generic Drug Study Integrity), across 4 days covering the study data, systems, processes and controls.
Navitas Life Sciences fully and successfully supported the seamless conduct of the review with prompt data provision, that culminated in a successful closeout, “without any observations for discussion”
Thank you for sharing this great news with us. Congratulation Navitas Life Sciences team for the successful FDA Audit.
– Global leader in Generic Pharmaceuticals.
Congratulations for successful USFDA audit with no objectional conditions.
– Leading Global Generic Pharmaceutical company.
Congrats and great to hear about the USFDA inspection without any findings.
– Leading Malaysian Pharmaceutical Consultant.
7. Is the Spontaneous Reporting System for Adverse Drug Reactions delivering as it should?: To ensure public health safety, the use of drug products or medicines must be monitored using an effective pharmacovigilance (PV) system. A Qualified Person responsible for Pharmacovigilance (QPPV) is accountable and must ensure that all legal obligations of the Market Authorization Holder (MAH) are met in respect of pharmacovigilance and the monitoring of the drug product in the market.
In this blog, Navitas Life Sciences’ Director of Pharmacovigilance and Global QPPV, Dr. Philipp Hofmann, MD, explored the spontaneous reporting system of adverse drug reactions (ADRs) as he looked at whether it was delivering as it should.
What is a Spontaneous Report?
According to the European Medicines Agency (EMA) a Spontaneous Report is ‘An unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organisation (e.g. the World Health Organization, a regional centre, a poison control centre) that describes one or more adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.’
8. How Navitas Life Sciences Supports Efficient Total and Transferrin bound Iron assay for Iron Sucrose formulations: To meet the demands of the healthcare industry, Navitas life sciences has developed robust methodologies for evaluating Iron-Carbohydrate preparations, leveraging our extensive knowledge about the complexities in iron sucrose preparations and the availability of the right resources. Our ability to find unique solutions to addresses customer expectations in a regulated bioanalysis environment aid us in bringing your iron preparation to the market faster.
This blog includes an interview with K V Lakshminarayana, General Manager-Bioanalytical, Navitas Life Sciences to understand more about the facilities and capabilities offered by Navitas Life Sciences towards supporting efficient Iron Sucrose Bioequivalence studies.
9. What makes our QPPV Services Unique?: A Qualified Person for Pharmacovigilance (QPPV) is personally responsible, by law, for the safety of the human pharmaceutical products marketed by that company in the EU. The QPPV must reside in the EU and should provide support across the globe through in-house QPPVs and a network of Local QPPVs.
This blog examined just what makes our QPPV services unique, we also explore the journey of our Head of Pharmacovigilance, QPPV, Dr. Philipp Hofmann, MD following his decision to move away from medical practice to the pharmaceutical world. Learn how he has applied his experience to evolve strategies that ensure the delivery of a world class PV system.
10. Celebrating 10 years of partnership for Regulatory Services with a Top 10 Global Pharma: Navitas Life Sciences celebrates 10 years of partnership for regulatory services with a top 10 global phama, aiding them in taking their products to the global market by providing vital support to cater to regional regulatory requirements.
To understand more about the support offered to the Top 10 global pharma, we met with Mr. Mallikaarjunan, Vice President - Regulatory Services at Navitas Life Sciences for an insight rich interview session. Read the blog to find out how the expertise of Navitas Life Sciences helped meet the needs of the global pharma, resulting in a long lasting partnership.
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