Navitas Life Sciences is proud to present a webinar on “Technology Enabled Centralized Data Surveillance in Risk Based Monitoring: Thinking the Unthinkable”on 25th January 2023 between 10:00 a.m to 11:00 a.m EST.
The webinar promises to be an exciting journey into identifying how technology can be utilized for data surveillance in risk based monitoring. To get a sneak peek into what awaits at the other side of the webinar, our latest blog brings together the speakers, Dr Akash Gadgade, Senior Manager - Medical Services, Medical & Scientific Affairs, Navitas Life Sciences, Janel Shelton-DeMagnus, Clinical Research Manager, Navitas Life Sciences, and Sumit Vishwambharan, Associate Director, Clinical Data Analytics and Risk-Based Monitoring, Navitas Life Sciences. Read on to find out more.

Dr Akash Gadgade
Senior Manager - Medical Services,
Medical & Scientific Affairs
Tell us more about your professional journey
I am a Medical Doctor with over 10 years’ experience in Clinical Research domain, completed medical education (MBBS and MD) from top medical schools of India. I have presented research paper in National and International conference, publications in Journals, worked with top sponsor as well as CRO companies in India, in the clinical trials.
I have rich experience across diverse therapeutic areas and more than 20 studies across all the phases (I-IV) for both drugs, and devices.
Please briefly describe what you will be discussing during the webinar
How RBM helps Medical Monitors to review data on real time and raise the trigger alerts at the subject, site and study level.
What are the key focus areas of research in 2023?
The key areas of focus for 2023 will be Oncology, Immunology, Pulmonology, Diabetes

Janel Shelton-DeMagnus
Clinical Research Manager,
Navitas Life Sciences
Tell us more about your professional journey
My interest and passion for clinical research began during my time as a research study coordinator at the University of Texas Southwestern Medical Center Internal Medicine and Infectious Disease departments. After several years as a clinical research coordinator and post graduating from Physician Assistant school, I spent several years practicing in emergency medicine and trauma prior to transitioning to clinical research management for a traumatic brain injury clinical at a military treatment facility. In my role, I was actively involved in all aspects of clinical trial operations including protocol development, startup activities, protocol finalization and execution, participant recruitment, and through study closure. I have approximately 8 years of clinical operations management on the site side. My experience includes a vast array of experience in clinical research practices, regulatory submissions, FDA regulations, good clinical practices, and IRB submissions. With an additional 5 plus years of experience managing and overseeing clinical trials from the sponsor side, I gained an array of experience with protocol development and execution from the site side including ensuring adequate oversight of vendor management activities, clinical trial monitoring activities, and clinical supplies.
Please briefly describe what you will be discussing during the webinar
During my allotted time, I will be defining RBM and discussing the process of successful implementation of a risk based monitoring approach including the incorporation of any indicated systems. I will describe the risks and benefits as they directly relate to the implementation of a risk based monitoring approach to clinical trial conduct from the clinical operations viewpoint.
What is the global awareness about clinical research, post COVID-19?
The COVID-10 pandemic moved clinical research to a more digital, remote, and decentralized environment. With the development of vaccinations for COVID-19, the awareness of clinical research and the conduct of clinical trials was on the fore front of the news worldwide. The increased publicity surrounding clinical research has led to a more public and widespread awareness of the conduct of clinical trials. The ability for Sponsors to conduct clinical trials remotely, signifies a more streamlined and rapid approach to the initiation and conduct of clinical trials. This new approach will allow Sponsors and the FDA to bring newer and more innovative therapies and treatment options to market more expeditiously.

Sumit Vishwambharan
Associate Director, Clinical Data Analytics and Risk-Based Monitoring,
Navitas Life Sciences
Tell us more about your professional journey
After completing my Masters in 2009, I joined a sponsor company within the Clinical Research domain.I liked working with data and that lead me to shift within the Clinical Analytics domain in mid of 2015. I have worked across different teams including Centralized Monitoring, RBM and Analytics which helped me gain immense experience and knowledge.
I joined Navitas Life Sciences in 2019 and I have been leading the Analytics team for all the different services within the organization. My role includes applying modern BI/AI technologies in medical data and operational analytics, collaborating with various functional teams to develop and lead digital strategy and technology capabilities, in alignment with business objectives.
Please briefly describe what you will be discussing during the webinar
I would be a part of the panel discussion on various aspects of an RBQM study conduct and how technology helps to achieve some of the needs.
What are the action steps to be taken to improve clinical data efficiency in 2023
I am a huge advocate of Data Literacy & Digital Transformation. For me, the key actions are
- Improve Data Quality and use enterprise data analytics to help drive business decisions.
- Establish a Data Quality standard across the organization.
Data quality is directly linked to the quality of decision making.
Webinar on Technology Enabled Centralized Data Surveillance in Risk Based Monitoring: Thinking the Unthinkable
Date: Wednesday, 25 January 2023
Time: 10.00 am - 11.00 am EST
This webinar will articulate key themes like:
- Remote Data Collection, Centralized Monitoring, and Decentralized Clinical Trials
- Centralized Monitoring: a Greater Advantage to a Broader Range of Trial
- What is RBM and how the RBM approach can Improve clinical trial data quality
- Successful RBM Execution and Harmonization