DISCOVERY
Uncover breakthrough
innovations during the drug
discovery phase.
innovations during the drug
discovery phase.
Raw Material Control for Biotechs (Part 2): Clinical Development Considerations
Introduction
Moving from Discovery to Commercialization in Precision Medicine
The revolution in precision medicine, a form of medicine using information about a ...
Rare But Not Forgotten: Opportunities in Rare Disease Drug Development
This article was co-written by Samantha Zappia, Principal Consultant, SK Regulatory ...
Should You Bring Your Trial Master File In-House?
This article is co-authored by Mike Lynch. A Trial Master File (TMF) is an ecosystem of ...
Critical Steps Towards a Collaborative Partnership and Governance Model
When crucial clinical trial activities are delegated by a sponsor to their vendor, the ...
The Vital Role of Collaboration and Leadership in Phase 2 Trials
In the intricate world of pharmaceutical development, the journey from a promising ...
Leveraging Outsourcing and Mixed Model Staffing Amid Layoffs
In the dynamic landscape of business, layoffs or losing momentum in a program with faulty ...
Navigating the Path to FDA Approval: The Importance of a PDUFA Date
As a biopharmaceutical company advancing through the phases of clinical development, each ...
Moving Towards Sustainability in Clinical Research – Call to Action
The life sciences industry is becoming more focused on sustainability practices – a ...
Elevating Your Clinical Trial Audits with AI and Centralized Monitoring
This article is written by Elizabeth Bodi and Mike Lynch. Clinical trial audits serve as ...