Sponsors often take for granted the fact that early phase trial design and operations can make or break future studies. When hard data is severely limited and is used to predict well beyond its boundaries, the quality of that data is absolutely paramount. The data obtained from phase 1 first-in-human studies through phase 2 proof-of-concept and dose range finding studies are vital to effectively designing future registration studies. Early phase clinical trials should be safe experiments on humans, not small-scale phase 3 trials. Therefore, it is beneficial to intelligently optimize early phase clinical activity to ensure successful trial execution and regulatory approval.

The mission of the 4th Clinical Trials Phase I & Phase IIA Summit is to provide attendees with the strategies and insight necessary to ensure their early stage clinical trials are executed on time and within budget, while exploring how to leverage innovative approaches to managing clinical trials for all therapeutic areas.

Top Five Reasons to Attend

1. Implement adaptive study designs and predictive models to successfully accelerate early phase trials
2. Improve vendor identification and communication from negotiation to study execution
3. Overcome the evolving challenges of patient recruitment and retention for different diseases
4. Leverage techniques to help identify genetic predisposition and risk factors for adverse events and drug reactions
5. Discuss innovative strategies to optimize early phase clinical trial operations

Who Should Attend

This conference is designed for representatives from pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:

• Clinical Research/Operations/Outsourcing/Affairs
• Early Phase Research/Development
• Pharmacology/Pharmacokinetics/Pharmacodynamics
• Pharmacovigilance
• Translational/Experimental Medicine
• Biostatistics/Biometrics
• Pharmacometrics

• Clinical Data Management/Statistics
• Clinical Innovation
• Regulatory Affairs/Compliance
• Medical Research/Affairs
• Patient Recruitment/Engagement
• Drug Safety