Dr. Manish Harsh, Vice President, Clinical Data Services provides key insights about the impact of technology on efficient clinical data management
The clinical trial industry has entered a new era in which the physical aspects of the trial are becoming increasingly associated with the digital realm. There is data generated from watches, cell phones, to smart clothes, allowing access to better insights to optimize operations and, thereby, to improve productivity.
In 2021, the global clinical data analytics market was found to be $8 billion and it is estimated to grow to $50.7 billion in 2026 at an estimated CAGR of nearly 45%. Data in itself is not useful, unless it is utilized to provide rich insights. Navitas Life Sciences has been investing in the right technology for many years to ensure that the complete value of clinical trials is captured seamlessly.
Dr. Manish Harsh,
Clinical Data Services
Navitas Life Sciences
Navitas Life Sciences’ Skyrocketing Influence on Enhancing Clinical Trial Value
Navitas Life Sciences offers end-to-end data management solutions that combine data management with analytics, adding value to clinical trials. There is considerable reduction in manual work, with improved personalization and forecasting that aid in better management of clinical trials.
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) leverage data to improve efficiencies.
Navitas Life Sciences’ Technological Prowess
- Deep acumen in technology and expertise in analytics and data sciences
- OneClinical®, AI and analytics-based clinical trials management platform
- Eight unique technology IIPs customized around Life Sciences
- The only Company to host 10 unique proprietary Life Sciences industry’s network forums
- Two ISO 27001 compliant data centers
In a recent interview, Dr. Manish Harsh, Vice President, Clinical Data Services, discussed how Navitas Life Sciences provides a competitive advantage by utilizing technology to make distinctive improvements to processes and capabilities
When did you identify clinical data services as the right career for you? How has the journey been so far?
My interest in healthcare based data analysis began when I was studying medicine. When in medical college I participated in medical surveys and data science related pilot projects. In 2008, when I worked for a pharma company, I worked on a project on a large scale project involving cardiac patients. This helped me understand the extent of impact of good data management and the power of data. That was the beginning of the journey, and it continues till today, as I seek newer and better ways to utilize data.
What are the essential skillsets and competencies for Clinical Data services?
The first and the most important is to have an in-depth knowledge and a practical understanding of the implementation of Good Clinical Practice (GCP).
Another key criterion is for all the professionals to understand the impact of these practices on patient safety. Ultimately, it is all about patient safety.
What are the emerging trends in Clinical Data Services?
Digitalization is a part of everyone’s life, whether it is consumer based or service based sector. During the last 10 to 12 years, the evolution of data sciences has been significant. In 2004-2005, there was a lot of paperwork, after which electronic data capture (EDC) platforms were adopted. Around 2011-2012, there was risk based monitoring, with a digitalized approach to data management.
At this juncture, the overall cost of development of drugs was high, with most of the cost going into clinical monitoring. There was collective requirement to leverage the latest technologies to convert the entire process into a digital form and then adopt the new processes in a more digitalized manner.
The current trend is that most customers are inclined towards the automation and digitalization of the processes and open to adopt tools and technologies for processes that were traditionally manual. Adoption of tools and adopting new trial designs are the two most prominent trends.
How is Technology supporting Clinical Data Services?
The overall clinical trial process is very complex, from protocol development to clinical study report. Technology helps reducing redundancy. For example, in clinical monitoring, which is an expensive part of the drug development cycle, a CRA prepares for site visit, then goes to the site, completes work there and gets back to write the reports. A lot of time is consumed, which affects the overall time and cost of clinical trials.
Now, there are a lot of tools to reduce such manual work, thereby reducing time, cost and efficiency of clinical trials.
What is your perspective on the use of digital tools for Clinical Data?
We are at an early stage of digitizing data collecting during clinical trials. Apart from EDC, there are newer methods like the use of e-source or collecting data through IOTs. Such methods, if validated and found relevant, will help in transforming clinical trials.
How has Navitas Life Sciences adopted to technological advancements?
Navitas Life Sciences is on par with industry adoption of digital tools. During the pandemic there were strict timelines and we had to conduct remote trials. One trial was for a COVID drug.
While the trial was conducted in the middle east, the data was collected by remote clinical research associates (CRAs) in India. We used cutting edge technology like OneClinical and Advanced Analytics that gave us a good competitive edge. The e-probe based and IOT based are technologies that we are exploring, and which will further enhance our technological strength.
How did Navitas Life Sciences exhibit resilience during the COVID-19 pandemic?
We have done multiple COVID- 19 trials and grown significantly as we were one of the successful CROs. Most Indian pharma interact with Navitas Life Sciences for their clinical trial needs. Even in global scenario, we have a good presence in the U.S and in Russia, with U.S Federal agencies choosing us for some of their work. There are multiple commercial pharma companies who continue to work with us globally. Recently a global big pharma and commercial company has shown keen interest in our work.
Highly Efficient Safety and Efficacy Evaluation of COVID-19 Therapies in Moderate to Severe Patients
- Quickly activated sites within 20 days
- Achieved FPI within 30 days of study award
- Recruited Patients ahead of time
- Comprehensive trial oversight through our in-house analytics platform
How has OneClinical® risen as an essential tool for efficient clinical data services?
The feedback about OneClinical® has been very encouraging, with a demonstration of our ability to use such tools garnering a lot of interest from global pharmas who choose to partner with us. We have been able to bring heightened efficiency into our clinical trials with OneClinical®.
OneClinical® is also evolving with changing needs of the industry. Currently it is helping us significantly improve clinical trials. The next release or version of OneClinical® is scheduled in October, with more functionalities being added and with enhancement of capabilities.
What is the advantage of choosing NLS for Clinical Data services?
The first part is that our thought process is very digital. From the very first day we think digitally, which saves sponsor time and money without compromising on quality. In the future, we want all the manual processes to be done away with.
Currently, whether it is data management or core project management, we provide dashboards that let sponsors understand the study progress. We understand the depth of involving technology into multiple aspects.
The second critical factor that makes Navitas Life Sciences stand out is our onus on quality. Whether it is for a local authority or a global business, our training methodology and approach to delivery is focused on quality, with no compromise. Quality stands above profitability and is at the heart of everyone at Navitas Life Sciences.
The third aspect is the segment in which we operate. We are the only mid-size CRO, which offers Phase I to Phase IV clinical trial support at a very reasonable budget, which is our strength.
Meet our Experts at SCDM Live to learn more about our Unique Data Management Services
Date: September 26-29 2021
Theme: Future Now v2.021
Topic: Decentralized Clinical Trials, AI/ML, RBQM, Post Covid Impact, CDM, Technology, Data and Communications, and more.