The logistics of clinical trials - a complicated business made easy with the right provider.

In order to ensure the effectiveness of the supply chain, attention must be paid to each link making sure every one complies with all necessary regulations and standards. This process must be carried out by an experienced professional, paying particular attention to the end result.

Can you tell us what’s involved in the "Logistics of clinical trials"?

Logistics of clinical trials involves the following activities: sourcing and supply, customs clearance, storage in compliance with the appropriate temperature regime, as well as transportation and delivery of all trial-related materials to clinical trial sites and where indicated direct to the patient. It also includes the retrieval, collection, and certified destruction of trial materials when the study is complete.

Dealing with the logistics of clinical trials is a complex process as the sector is highly regulated. Can you tell us a bit about what standards, directives regulate transport, storage, and delivery of clinical trial supplies?

Storage conditions for investigational drugs, comparators and concomitant therapies are governed by the World Health Organization (WHO) and specific requirements for storage and transportation are laid out in the following documents:: “Good Storage Practice for Pharmaceutical Products” (Guide to Good Storage Practices, GSP), and “Good Distribution Practice” (Good Distribution Practice, GDP).

What is involved in the delivery of logistics of clinical trials?

Local customs and importation regulations must be followed when importing and delivering clinical supplies in any particular country. For example to import any drugs or materials for clinical trials into the customs territory of Ukraine, an Order of the Ministry of Health of Ukraine on the approval of such a clinical trial, certificates of analysis and a certificate of conformity must be submitted.

It’s clearly a complicated business - how do you choose the right company to deliver these services to support clinical trials?

First of all, you need a full-cycle company, that is, one that includes in its service offering all aspects of logistical support for clinical trials from sourcing and supply to delivery. You also need a company committed to constantly reviewing all links in the supply chain to ensure the utmost efficiency and transparency. The optimal choice is a provider guided by the “single window” principle, that is when the customer submits an application online and waits for the result, they are enabled to monitor the progress of work at any stage.

Who controls the supply chain: customer (Sponsor), sender, carrier, recipie? If you choose to cooperate with a full-cycle company, then they assume responsibility for the supply chain so you can concentrate on other aspects of your study.

By what means do logistics companies provide their customers with transparency? What role do loggers, thermal sensors, online surveillance, etc. play?

In the logistics of clinical trials, temperature indicators are of key importance because any variation can directly affect the quality and safety of the product. This is why a provider will use a variety of means to monitor temperature regimes - providing special vehicles with thermal boxes and sensors connected to an online surveillance system. In addition, high-precision loggers are used to monitor temperature and humidity levels.

Is it possible to describe a typical logistics chain, indicating the participants and risks within each stage?

The logistics chain provides for the fastest and most efficient delivery of goods from the manufacturer (supplier) to the consumer, so the process is classified as complex, since several links and actors are involved in it. The logistics company undertakes the planning, control, and management of the supply chain in order to mitigate any risks that, hypothetically, may hinder the execution of the task.

When considering risks one must take into account multiple factors including human error, transportation issues e.g. vehicles breaking down or re-routing being required due to road closures or bad weather, as well as organizational and strategic failures. To prevent these risks, a full-cycle company takes steps including working exclusively with trusted partners and certified lawyers, using a modern specialized fleet of vehicles and equipped warehouses, and implementing the most transparent, multi-level logistics scheme without the possibility of force majeure.

A full-cycle company with extensive experience identifies potential risks each stage - from the sourcing and purchase of supplies to the receipt of the goods by the customer, and uses strategies to minimize this. That is why we develop plans down to the minute whereby protocols for handling the goods are prescribed (temperature regime, air humidity, preservation of integrity, lighting, etc.), the number of permissible stops and their duration are defined (with temporary fixation), and the necessary documentary support is clearly identified.

Who evaluates the effectiveness of the supply chain: auditor, customer, etc. How should this be done?

International best practice as well as local regulations must be followed to ensure the effectiveness of the supply chain. This process should be carried out by a competent and experienced provider, paying attention, in particular, to the final result. The global logistic algorithm includes a chain: plan → do → check → act, which ensures the efficiency of the process and facilitates evaluation. The main criteria for the latter are customer satisfaction, process flexibility, and productivity.

Tell us about the reverse logistics service.

Reverse logistics is an integral part of logistics in general (including clinical). It is often identified with the disposal and recycling of waste, but its functions are not limited to this sector. Reverse logistics includes the purchase of returned or obsolete products for the purpose of further processing. The first and main advantage of this section of logistics is environmental protection. In the context of clinical logistics, the reverse direction is especially relevant.