Obesity White Papers & Case Studies
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A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution
8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
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2025 Global Report For In-Vivo CAR Cell Therapy
8/14/2025
Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.
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LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations
8/14/2025
Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.
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Understanding Immunogenicity In AAV Gene Therapy
8/14/2025
As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.
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Regulatory Strategy And Submission Support
8/13/2025
This Regulatory Operations Team enables biotech and pharmaceutical companies to focus on innovation while ensuring a smooth, compliant path to market entry.
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Regulatory Strategy And Submission Support
8/13/2025
Eliminate delays and ensure seamless regulatory alignment with an experienced toxicology services team.
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Accelerate Your Drug Development With A Global Partner
8/13/2025
With the right Chemistry, Manufacturing & Controls (CMC) consulting services, your organization can excel in early-stage strategizing, accelerate timelines, optimize processes, and reduce costs.
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Demanding More From AI Governance In Drug Safety
8/13/2025
Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.
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Targeted Indication Selection Using Adaptive Design
8/12/2025
What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?
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Advancing Dose Escalation Strategies With Bayesian Modeling
8/12/2025
A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.