Our Experts Explore the Potential of Decentralized Clinical Trials and Our Unique Capabilities

In a rapidly evolving clinical research landscape, decentralized clinical trials (DCTs) have emerged as a transformative approach, providing an efficient way to conduct clinical trials. To explore the unique capabilities at Navitas Life Sciences, we interviewed Dr Atul Gupta, Vice President – Medical Services and Client Solutions and Dr Akash Gadgade, Associate Director - Medical and Scientific Affairs who recently co-authored an article on ‘Key Takeaways from The FDA Guidance On DCTs’ published in Life Science Leader recently.

Dr Atul Gupta

Vice President – Medical Services and Client Solutions

Navitas Life Sciences is a strategic partner for multiple small to big pharma globally. How did we support the shift towards Decentralized Clinical Trials (DCTs)?

Navitas Life Sciences has always been dedicated to staying at the forefront of clinical trials. We recognized the potential of DCTs early on and made strategic investments in both technology and talent. This allowed us to seamlessly integrate novel technologies and data collection methods into our services, enabling us to efficiently support and execute DCTs.

We have the expertise to navigate the complexities of decentralized trials, ensuring we deliver results with the highest standards of quality and compliance.

What sets Navitas Life Sciences apart in terms of clinical trial capabilities, especially when it comes to supporting DCTs?

One of our core strengths is our ability to combine deep industry knowledge with technological expertise. This allows us to tailor solutions that meet the specific needs of our clients, whether they’re transitioning to DCTs or pursuing a more traditional approach.

Navitas Life Sciences leverages its domain expertise, technology knowledge, and world-class systems & processes to support unique needs. Our end-to-end clinical trials operations provide you support with Clinical program management, feasibility, site selection and activation, Patient recruitment, Site management and clinical monitoring (including Risk Based Monitoring (RBM), Central Monitoring (CM), Remote Monitoring (RM) & Adaptive monitoring).

DCTs have introduced new challenges, particularly in areas like patient safety and data management. How does Navitas Life Sciences address these challenges to ensure the success of DCTs?

Patient safety is at the heart of all our clinical trials. We have robust protocols in place to ensure that investigational products are handled with the utmost care, even in a decentralized setting. This includes comprehensive instructions, user-friendly tools, and real-time support for participants.

Dr Akash Gadgade

Associate Director - Medical and Scientific Affairs

How do you maintain data integrity and privacy during decentralized clinical trials?

We invested in advanced technologies and processes which are leveraged to manage efficient clinical trials. We have stringent data verification mechanisms, as well as privacy-preserving technologies to protect patient data. This ensures that data integrity is maintained throughout the trial.

As we move forward, what do you see as the future of DCTs, and how is Navitas Life Sciences positioned to lead in this space?

The future of DCTs is incredibly promising. We anticipate even greater adoption rates as the benefits become more apparent. Navitas Life Sciences will continue to power your clinical trials with the right expertise, experience, artificial intelligence and digital tools to avoid costly delays and gain a competitive edge. Access our global teams and get support from multiple geographic locations and patient populations to rapidly start your clinical trials with diversity and safety at the core.

Key Takeaways from The FDA Guidance on DCTs

Explore some highlights of the recent FDA guidance for conducting DCTs in the recent article, including:

• Embracing Novel Technologies
• Adapting Informed Consent
• Patient Safety and Delivery of Investigational Product
• Data Collection and Management
• Centralized Monitoring

Read Now

Dr. Atul Gupta

Vice President – Medical Services and Client Solutions

Dr. Akash Gadgade

Associate Director - Medical and Scientific Affairs

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