Resources

Expedite your clinical study with a Pre-IND Speed to Study Strategy

Is your drug product manufactured outside of the United States? Do you have challenging dosing milestones?

Delivering the Full Value Chain for Oncology Clinical Trials

Oncology clinical trials are always challenging, and clinical approaches and the needs for supportive services continue to evolve

Choosing The Right CDMO For HPAPI Manufacturing, Development & Packaging

Safe handling of highly potent molecules is complex, and the associated regulatory requirements are growing. As a result, pharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging a

Partner Perspectives To De-Risk Commercialization Of Combination Products

Developing an effective drug-device combination product for self-administered biologics is a complex process

Navigating the New EU Clinical Trial Regulation: 536/2014

The European Clinical Trial Regulation 536/2014 (CTR) will be coming into full effect in 2022, and will significantly change how companies conduct their trials.

Water Cooler Chat: Are You Ready for your Qualified Persons Audit?

Many of our sponsor companies, have not had previous experience of European Union requirements for clinical trials or commercial products, in this session we will discuss the requirements of Qualified Person audits.

When it comes to pharmaceutical and biopharmaceutical supply chain expertise who do you trust?

Your bridge between life-changing therapies and patients