DISCOVERY
Uncover breakthrough
innovations during the drug
discovery phase.
innovations during the drug
discovery phase.
Reimagining Clinical Studies to Support Accelerated Approvals
There is, and always has been, a need for speed in drug development. While, in many ways, ...
Establishing a Culture of Quality: What Every CMO Should Know
Leaders at biopharma companies often ask us, “What is a culture of quality and how do you ...
A Successful Pre-IND Enabling Next Stage of Development
Regulatory Case Study Pre IND DOWNLOAD THE CASE STUDY
Halloran Opens Second Office in San Diego
“Halloran Opens Second Office in San Diego” was originally published on Contract Pharma. ...
Early Collaboration with FDA for Novel Programs: Maximizing the Emerging Technology Program (ETP)
Established in 2014, the U.S. Food and Drug Administration’s (FDA) Emerging Technology ...
FDA Issues Final Guidance About Multiple Endpoints in Clinical Trials
On October 21, 2022, the U.S. Food and Drug Administration (FDA) issued the “Multiple ...
Aligning Your Clinical Operating Model – a Case Study by CSL Behring
CONTENT IN COLLABORATION WITH CSL BEHRING Valerie Reynaert, Head of Global Clinical ...
FDORA and the Diversity Action Plan Requirement – Are You Prepared?
The U.S. Congress recently took action to improve diversity in clinical trials by ...
Critical Considerations to Advance Gene Therapy Products for Rare Diseases
The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research ...
Future Proofing Your Clinical Data Infrastructure
Content in Collaboration with eClinical Solutions Written by: Raj Indupuri, CEO, ...