Newsletter | July 23, 2024

07.23.24 -- Are Novel Drug Production And Compliance Timelines All Wrong?

FEATURED EDITORIAL

Have We Got Novel Drug Production And Compliance Timelines All Wrong?

Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

INDUSTRY INSIGHTS

When Protocol Amendments Meet RTSM

Learn why an RTSM solution should be adaptive and flexible, and should help clinical trial teams uncover the best ways to handle protocol amendments.

Sponsor Overcomes Hold And Steers Products Through Development

Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

The Catalyst Of Decentralized Clinical Trials: Combining Clinical And Digital

Decentralized clinical trials are made up of a multitude of elements, from in home clinical capabilities, logistics, digital platforms, and technology, to global reach and more. This webinar shares important factors to consider to build your DCT ‘molecule’ successfully.

SOLUTIONS

Proven Vial Containment That Scales From R&D To Commercial

The Key To Compliance, Patient Safety, And Risk Based Monitoring