Early Phase Development

Pre-IND & IND Filing Support

Meet your critical milestones as we help you prepare your product for IND filing. From documentation to submission, we tailor your experience and help you navigate every step you need to get your product ready to begin trials – from dose selection to study design and analyzing pharmacokinetics data and writing final reports to support IND submissions.

First-in-Human Studies

With a deep understanding and expertise in your drug compound, we work closely with you to select the right patients and sites for your first-in-human trials and support dose escalation studies to assure the highest level of patient safety.

We collaborate and share knowledge to inform decisions around dosing as trials move forward, analyze Pharmacokinetics/Pharmacodynamic (PK/PD) relationships to make sure we have optimized doses, and support with strategies for sampling and data analyses.

Commercial Strategy & Clinical Pharmacology

Our clinical pharmacology package supports your BLA submission and helps you rapidly and accurately respond to regulatory queries. Our team explores exposure/risk balance to inform dose selection decisions for market authorization submissions.

Early Phase Development services:

Whether you come to us for full-service end-to-end support or on a single project basis, we support you across a wide range of services to optimize your Early Phase development procedures, including:

• Conduct final analysis of Pharmacokinetics (PK) data and write a final report to support IND submissions
• Examination of Pharmacokinetics/Pharmacodynamic (PK/PD) relationships to ensure doses are optimized to progress to Phase III
• Collaboration with teams to inform decisions around dosing in trials
• Supporting strategies for sampling and data analyses
• Exploring exposure risk balance to support submissions.
• Support dose selection for BLA submissions (market authorization)
• Clinical pharmacology packages support submissions and respond to regulatory queries.