Resources

White paper: Rapidly Switching to Direct-To-Patient Protocols

AUDIO: In the midst of the COVID-19 pandemic, clinical trial sponsors are having to quickly find alternative methods to keep their trials moving forward as challenges arise such as clinical sites having to close, or patients being unable to...

Update on EU Compassionate Use Programs

AUDIO: Compassionate use supplies in Europe are unlicensed medicines and not traditional clinical trial supply. As such the quality and distribution considerations are different for compassionate use supplies in Europe...

Gavin Morgan On Strategies For Utilizing Depots For Global Distribution Of Clinical Medicines

Manager of Global Clinical Storage and Distribution Gavin Morgan identifies considerations when employing a depot network for shipping to global investigational sites

Implications for Shipping of Clinical Materials into the European Market

Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mould on paracetamol (acetaminophen) tablets

Six Strategies to Stretch Your Limited Clinical Study Drug Supply

Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex

EU Good Manufacturing Practice ANNEX 13 Investigational Medicinal Products

Can you imagine working for months to ensure your clinical supply strategy is in place for your European studies, only to have them be delayed because labeling requirements were out of compliance, and the QP or the site(s) rejected the materials you

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