Clinical Trial Supply Chain

In an earlier article, we reviewed the randomization risks that could arise if an interactive response technology (IRT) system isn’t designed and/or implemented correctly. Here we address the consequences that trial sponsors could face if their IRT system isn’t adequately designed to handle the many and often complex drug allocation and trial supply aspects of their clinical trials.

It is unrealistic to include infinite adaptations in an IRT system, thus identifying the optimal level of adaptations requires examination of the study’s characteristics and planning phase considerations.

This is the first of two articles on the consequences that could arise if an interactive response technology (IRT) system isn’t designed and/or implemented correctly and how a trial could quickly go off track based on risks related to randomization, drug allocation, and trial supply.

Identifying areas of burden and steps supply chain operators can take to alleviate them.

AI can also help reduce waste from 70% to 25%.

Panel at SCOPE discusses the possibilities of research in a post-COVID world.

Concept of flexibility acting as driving force behind industry’s swift response to COVID-19.

How smart packaging can aid clinical trial adherence.

COVID-19 provides unique opportunity for overhaul of logistics.

The success of the decentralized model hinges on coordination between stakeholders across the supply chain to ensure that date is secure, medication is delivered on time, and in proper condition.

Expectations for trial design will continue to change, and it’s critical that IRT vendors continue to listen to their customers and evolve their offerings accordingly.

The importance of examining this generation’s influence on the clinical trial value chain.

Automation will be key to improving efficiency and mitigating risk during the complex process of cell therapy production and delivery.

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 Packaging

Clinical laboratories arranged by type of diagnostic service provided