Transforming groundbreaking science into viable therapies demands more than ambition—it requires regulatory experience, biomarker intelligence, and a deep understanding of clinical trial intricacies.
At BioTargeted Solutions, we empower biotech and pharmaceutical pioneers to expedite IND approvals, craft biomarker-driven clinical strategies, and navigate the complexities of drug development with confidence.
Services
Drug Development & IND Strategy
Guiding companies through regulatory submissions, optimizing IND packages, and streamlining approval pathways.
Example Strategies:
Exploratory IND: Rethinking the Clinical Drug Development Strategy
Biomarker Plan Development
Designing biomarker-driven clinical trials to enhance patient selection, improve efficacy, and increase trial success rates.
Example Exploratory Endpoints:
Use of ctDNA for Early-Stage Solid Tumor Drug Development
Plasma ctDNA Response Is an Early Marker of Treatment Effect
Let’s Discuss Your Project – We offer a free initial consultation to explore how our expertise can support your success.
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