CRO Services
Practical Strategies for ICH Q14 and Q2(R2) Compliance
The recent adoption of ICH Q14, Analytical Procedure Development, and the revised ICH Q2(R2), Validation of Analytical Procedures, effective since June 2024, represents a significant evolution in regulatory expectations for analytical procedure development, qua
The Year in Review 2025
30 Years of Innovation in Drug Development: The Evolution of the Contract Research Organization
Over the past three decades, drug development has evolved rapidly—driven by new technologies, tighter timelines, and greater collaboration. CROs like Altasciences have transformed, shifting from service providers to strategic partners.
Case Study: Achieving a 505(b)(2) Regulatory Approval for Multiple NDA-Enabling Studies
Hybrid medicines are drugs based on an approved active substance (or previously approved drug) and have a different route of administration, format, strength, or indication from the original reference product.
They require approval for market authorization based on both data from the original reference medicine, and from new clinical trials on the modified version.
Case Study—Accelerating Recruitment in Renal Impairment Trials: Leveraging Specialized External Sites
7 Tips for Navigating the Complexities of In Vitro NAMs Studies
As a board-certified toxicologist and experienced Good Laboratory Practices (GLP) Consultant, I spend quite a bit of time advising on quality issues of New Approach Methodologies (NAMs) in support of toxicology programs. While these alternative methods are exciting and full of promise, they come with their own set of challenges.
STAT: Responsible AI Frees Scientists to Focus on Science
Clinical Trials Without Boundaries: Multi-Site Solutions at Altasciences
The Year in Review 2024
4 Essential Topics to Cover in Your First CRO Meeting
