Meet us at ISCR: Next Steps to Efficient Clinical Trials

As a leading Global CRO, Navitas Life Sciences is happy to be a Platinum Sponsor at ISCR’s 16^th Annual Conference on ‘Demystifying Innovations in Clinical Trials’ to be held on 23-24^th February 2023 at Pullman New Delhi Aerocity, India.

ISCR is an association of Indian Clinical Research professionals, bringing together everyone engaged in clinical research activities in India. This is the first in-person annual ISCR conference since the beginning of the COVID-19 pandemic.

The conference presents an exciting opportunity to gain insights from our experts Dr. Yun Lu and Dr. Atul Gupta and on

• The important and impactful industry trends and regulations
• The most effective Innovations in Pharmacovigilance
• The key concepts in Centralized Medical Data Review
• The crux of adapting Clinical Data Management to Decentralized Clinical Trials.

We met with Dr. Yun Lu Chief Science & Innovation Officer, Navitas Life Sciences and Dr. Atul Gupta to find out more about what’s in store from them at ISCR’s 16^th Annual Conference.

Dr. Yun Lu, PhD

Vice President & Chief Science and Innovation Officer,

Navitas Life Sciences

Track Session on “How Does CDM Adapt to the DCT Trials?”

Date: 24-Feb-2023

Time: 4.30 to 6:00 pm

Duration: 20 minutes

Tell us more about your professional journey

I have vast clinical data experience, and am responsible for global development efforts towards Clinical Data Science and eSolution. I lead efforts to incorporate CDISC into the electronic data capture system and submission to the U.S. Food and Drug Administration (USFDA) and the development of therapeutic/disease specific Common Data Elements (CDEs). I have extensive experience in supporting clients in academia, government, disease foundations and the private sector.

I am the VP & Chief Science and Innovation Officer for Navitas Clinical Research (NCR), a part of Navitas Life Sciences. As an integral member of the Navitas Clinical Research Executive and Senior Leadership Team, I take an active role in Project Governance, Financial Management/Outcomes, Staffing Planning/Allocations, and, Business Development leadership/assistance.

What will your session at ISCR focus on?

I will be presenting under the Clinical Data Management Track Session 6. The session will focus on the evolving clinical data landscape, modernization of technology and data life cycle to support decentralized clinical trials (DCTs). Clinical data manager’s role and capabilities to adapt to the DCTs will also be discussed.

Why are decentralized clinical trials (DCTs) considered the future of clinical trials?

DCTs enable the implementation of patient-centric clinical trials, bringing clinical research to patients through technology. They aid in improving participant recruitment and retention by leveraging real-world data, real-world evidence, while supporting adaptive designs, accelerating clinical trials, and reducing cost.

What are the strategies to adapt Clinical Data Management to Decentralized clinical trials (DCTs)?

The clinical research landscape is continuously evolving, DCTs have a direct impact on the innovative technology and data management needs. Increasingly, clinical research involves collection of data from various sources and systems, with disparate data types and formats. Harmonizing, integrating and interpreting such data requires clinical data managers with a more complex background and skillset.

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

Published on 6th January 2023 in

Read the Article Now

Dr. Yun Lu, PhD

Vice President & Chief Science and Innovation Officer
Navitas Life Sciences

Elisa Ahmanson

Associate Vice President Clinical Operations
Navitas Life Sciences

The Society for Clinical Data Management (SCDM) Innovation Committee has been leading the effort to consider all 5 V dimensions (Volume, Variety, Velocity, Veracity, and Value). We propose 4 Strategies for Data Managers to Advance Data Science, including aligning with clinical data science strategy, analyzing key skills, effective training, and staying ahead. Data managers who can gauge the momentum of various tangible factors will help in transforming traditional data management to modern clinical data science. This will result in greater ownership of clinical trial data and ensure innovative solutions for data management and operational support for large and complex clinical trials.

Panelist for session on “Innovation as a way of life in Pharmacovigilance”

Date: 24-Feb-2023

Time: 3:00 pm – 4:00 pm.

Presentation on “Centralized Medical Data Review at the Core of RFBM: The Path to Success”

Date: 25-Feb-2023

Time: 3:00 pm - 4.30 pm

Duration: 20 minutes

Dr. Atul Gupta

Vice President,
Medical & Scientific Affairs
Navitas Life Sciences

Tell us more about your professional journey

I am a medical doctor and the VP-Medical & Scientific Affairs at Navitas Life Sciences. I have leadership experience in providing end to end scientific guidance in drug development (Phase 1-IV) across multiple therapeutic area portfolios, in diverse regulatory environments including FDA, EMA, MHRA, ANVISA and DCGI. I have worked as Global Medical Lead (USA, Europe, and Asia Pacific) in more than 50 studies across the continents for both drugs and devices. I have been involved extensively in developing complex innovative trial designs for complex protocols reducing the huge costs and time associated with standard clinical randomized controlled trials. Apart from being a medical lead, I have multifaceted experience in diverse clinical research domains including medical writing, medico-regulatory (IND, NDA, BLA), drug safety and operations. I have been the part of successful marketing authorization approval of breakthrough therapies including PD-1 inhibitors, V2 antagonist, multiple biosimilars, vaccines and several repurposed therapies (for MDD, narcolepsy, psoriasis).

Please briefly describe about your presentation at ISCR and what attendees will gain from?

I’d like to invite you all to our sessions at ISCR. I will be a Panelist for the session on “Innovation as a way of life in Pharmacovigilance” on 24th February and will be speaking on “Centralized Medical Data Review at the Core of RBM: The Path to Success” on 25th February. In my pharmacovigilance session I will be discussing the innovations in pharmacovigilance that are likely to bring a paradigm shift, especially the role of PV bots, AI, and automation. In my session on RBM, I will be focusing on the role of medical data review in centralized monitoring, which to my understanding is grossly underutilized and have huge potential to bring speed, success, and savings in clinical trials. With complex innovative designs (CID) being the way forward approach, the implementation of RBM will become even more pertinent. I will be discussing my experience with a recent ongoing large vaccine trial with more than 4000 subjects wherein RBM helped to optimize monitoring efforts and efficiency.

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