Celebrating Excellence in Clinical Research on World Clinical Trials Day

A day dedicated to raising awareness about clinical trials and honoring professionals associated with clinical research, World Clinical Trials Day, is celebrated on May 20th, 2022. It commemorates the first randomized clinical trial led by James Lind, a Scottish naval doctor in 1747 who started comparing treatments for scurvy on board HMS Salisbury. Together, we have traversed a long path, 274 years of clinical trials, to improving care for patients in need. The importance of clinical trials is becoming increasingly crucial, with decentralized clinical trials emerging as an essential tool in this pursuit.

Navitas Life Sciences is committed to Supporting Efficient Clinical Trials

Navitas Life Sciences has remained flexible and agile in delivering clinical development solutions specific for innovative emerging biopharma. Biotech companies partner with us to gain three decades of experience supporting the industry, from study design through execution. From phase I to phase IV, we support clinical trials from startup to closure with our regulatory insights and quality approach. Our services are backed by technology & analytics that are developed specifically to meet any unique challenges.

Global Clinical Research Services

At Navitas Clinical Research, we offer a unique flexible early engagement model to emerging biopharma and provide access to our global expertise to support your clinical development need.

We met with Sowmya Kaur, Executive Vice President Navitas Clinical Research and Dr. Yun Lu, Vice President & Chief Science and Innovation Officer, Navitas Clinical Research to find out what it is to be in this ecosystem.

What does it mean to be in the clinical trial industry?

Over the years, we have encountered incredible times within the Clinical Research segment. When I step back to reflect, there is a sense of satisfaction when I realize how our work has helped improve the quality of patients’ lives. The main goal of every project and every collaboration has been to augment the pace of product reach to patients.

Today when I hear stories of how patients benefitted from our innovative approach and collaborative efforts in bringing drugs faster to them, it is deeply gratifying, infusing in me the energy to begin another exciting day with hope. Some of these drugs are used by my own family, which is an extremely pleasant and soul-filling experience. There are so many families like this whose lives we have been able to touch, something that is worth the enormous amount of effort and resources required to develop drugs.

I am extremely proud when a drug, that was studied in a trial that I was a part of, makes it to the market and benefits people around me.

Sowmya Kaur

Executive Vice President

Navitas Clinical Research

What are the current trends in the clinical trials Industry?

There has been a paradigm shift towards digital and technology adoption across various stakeholders within the industry. Decentralized trial connectivity has brought in unprecedented levels of collaboration.

Across the clinical sphere, clinical trial execution and operation leveraging digital tools and solutions will be the key to innovation. I truly believe that this pandemic has drastically changed how we execute clinical studies, with safer and efficient study designs and greater patient centricity. Decentralized tools like remote monitoring, digital tools, telemedicine, and remote monitoring are the future implementation strategies for successful clinical programs and paving the way for patient-centric approaches.

In addition, post the pandemic, the biopharma sector views CRO partners with strategic and long-term intent. The need for guidance earlier during the portfolio planning phase and creating an alignment is critical toward a strategic direction. The partnerships have originated from initial strategic guidance, end-to-end solutions for overall development, and meeting their end goals of getting treatments faster to patients. The CRO partnership initiates even before Investigational New Drug planning and submission.

How did the clinical trial industry help the fight against COVID-19?

COVID-19 brought unprecedentaged changes to our lives and affected millions across the world. Scientists and clinical researchers across the world joined hands to support the scientific fight against COVID-19, in terms of developing new drugs, vaccines and pivoting existing drugs.

The tireless and concerted efforts of scientists and clinical researchers across the world aided in bringing vaccines for COVID-19 within a year. Previously, the vaccine that was brought fastest to the market was the mumps vaccine in 1960s, within a span of 4 years.

Navitas Life Science’s deft handling of raging logistics issues and its ability to leverage multiple strengths, including swiftly adapting to technological advancements, helped in the continuation of non-COVID and COVID clinical trials during the pandemic. Some key strategies adopted include online consultations, direct to patient shipment, home care visits to evaluate safety of patients and amendments to protocols. Patient safety and data integrity remained our biggest priority during the entire exercise.

What makes the clinical trial industry special?

The purpose of running clinical trials is to find new treatment, diagnosis and prevention of a disease and gain approval of a new product (drug or device). Clinical research brings the basic and translation science together with new treatment and care for patients.

How are disease registries different from clinical trials?

Patient or Disease registries are observational, based on the real world evidence, use data of patients from standard care, patient reported outcomes, and patients’ information of medical history, treatment and other information. The purpose of implementing a registry program is to characterize a disease and progress, define patient population and sub-populations, exam the use of certain approved drug or medical device, inform patient care and treatment. Registries can be very valuable to inform clinical research and future clinical trial design, possible targeted participants for recruitment, healthcare cost and policy decision.

Dr. Yun Lu,

Vice President & Chief Science and Innovation Officer,

Navitas Clinical Research

How is artificial intelligence enhancing clinical trials?

Clinical data are valuable assets. Machine Learning (ML) and Artificial Intelligence (AI) together with other modern technologies and approaches can help optimize clinical design, operation and innovation, predict and improve outcomes, reduce trial enrollment target and timeline, lower cost.

OneClinical^® provides near real time data during the clinical trial that can be used to take proactive corrective action, resolving critical issues at the onset. This will help in the intelligent deployment of resources, which can save your time and your money.

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