Clinical Trial Supply Chain

Gaps in the good manufacturing practice controls on medicines for clinical trials are targeted in new rules from the EU.

In this article, MedCision executive discusses cell therapies.

4G Clinical head of marketing, Amy Ripston interviews Catherine Hall, director of operational excellence, at Sunovion to discuss how IRT bridges the gap between clinical and supply, and how interactive response technologies (IRT) can be leveraged to enable innovative trial designs.

Issues of counterfeit drugs being introduced into a supply chain have been a concern in comparative clinical trials. Terry Walsh of GSK speaks about the addressing this issue and ensuring that comparator drug supplies are more readily available for comparative trials.

With cell-based therapies possessing multistep supply chains and complex track and trace, logistics management systems can be useful for trials even in the protocol-planning stage.

Cellular therapies offer potential to improve medicine and fill the needs of patients with few treatment options, though these products must be stored at cryogenic temperatures. Incorporating cold chain logistics into your clinical trial can prove beneficial in making these products available to patients.

With all the focus on various data capture solutions in the clinical trials world over the past decade(s), few people seem to have noticed the exponential advances made in the real workhorse systems of the trials: RTSM. Also known as IVR, IWR and IRT, these systems actually execute randomization, blinded supply and resupply management to depots and sites, and most importantly of all, drug dispensing. Is there anything more important to get right?

This white paper discusses the benefits of predictive technology to forecast the clinical supply needs of a clinical trial.

Clinical laboratories arranged by type of diagnostic service provided