Biosimilar Clinical Study

Ensuring Biosimilar Success with Comprehensive Support

Biosimilars development demands a strategic partner equipped with superior expertise and a deep understanding of regulatory frameworks. Navitas Life Sciences stands at the forefront, offering comprehensive support for biosimilar clinical trials. Our extensive experience in biosimilar clinical trials, combined with a thorough characterization of biosimilars, ensures robust trial design and execution. By leveraging our in-depth knowledge of the nuances between biosimilars vs. generics, we craft tailored strategies that address the unique challenges faced by biosimilars. Our holistic approach encompasses all critical aspects, from drug development and clinical study design to regulatory strategy and biostatistics, ensuring the seamless progression of your biosimilar projects.

Innovative Solutions for Cost-Effective Biologic Alternatives

As the global demand for cost-effective biologic alternatives grows, our commitment to excellence in biosimilars development positions Navitas Life Sciences as a premier Biosimilars CRO. With a proven track record in risk management, we proactively identify and mitigate potential risks, safeguarding trial integrity and optimizing project efficiency. Powering Possibilities in biosimilar programs from conception through to regulatory approval for providing innovative solutions and faster market reach.

Our Biosimilar CRO services include:

Biosimilar Clinical Trial Services for Levim Biotech

Navitas Life Sciences supported Levim Biotech's milestone achievement with a cost-effective Liraglutide biosimilar. Our expertise in operations and regulatory compliance ensured Levim's status as the first biosimilar launch in India, overcoming challenges even amidst a pandemic.

We found Navitas to be a highly reliable CRO partner with highest standards of integrity. Therefore, I will be more than happy to recommend Navitas Life Sciences for our upcoming clinical trials and to my colleagues in other companies globally.

Brochure

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Efficient Clinical Trials: Real-Time Oversight & Insights

Find out how Navitas Life Sciences ensures adherence to study timelines through In-depth domain expertise, robust medical and scientific talent pool, adoption and use of proven technologies.

CASE STUDY

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Oncology Phase III Biosimilar Rescue Trial for a Global Biopharmaceutical

Learn how When tasked with rescuing a phase III oncology biosimilar trial in India, Navitas Life Sciences delivered on-time, quality outcomes.

ARTICLE

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Current Status of Biosimilars and Their Impact on Pharmacovigilance

Published in: Pharma Exec
As the market for biosimilars expands, a nuanced approach is needed to balance cost considerations with patient safety and pharmacovigilance efforts.

Extensive Experience in Managing Efficient Biosimilar Clinical Trials

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Gain the Navitas Life Sciences Edge

Global Presence

Global Presence

Expert support available in North America, EU, and Asia Pacific.
Diverse Experience

Diverse Experience

Handling phases I to IV and beyond.
Proven Benefits

Proven Benefits

Streamlined processes, reduced costs, optimized outcomes.
Tailored Solutions

Tailored Solutions

Customized support for unique trial needs.
350+ Clients

350+ Clients

Repeat business from 90% of clients with multiple years of engagement.

BLOGS

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Biosimilar CRO: Biosimilar Clinical Trials Excellence for Levim Biotech

Find out how Navitas Life Sciences played a pivotal role in supporting Levim Biotech's Liraglutide biosimilar.
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A view on biosimilars – a status update and the impact on pharmacovigilance

In this blog, Philipp Hofmann, Director - Pharmacovigilance & QPPV, provides a status update on Biosimilars and their impact on pharmacovigilance.
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50 Sponsor Reviews You Must Read

Here is a collection of sponsor reviews of the stellar work that we provided them with, rethinking strategies and shifting priorities, even during the throes of the COVID-19 pandemic.

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