Mission Possible: Excellent Clinical Logistics

Insightful integration of Contract Manufacturing Organizations into clinical trial business

By Jens Mattuschka and Henriette Frangillo-Engler, Clinical Logistics Services, PAREXEL International

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The clinical trial supply chain is a conglomerate of many individual, sometimes multifarious, links that must be reasonably assembled to form a stable chain. It’s not simply a linear row consisting of a few simple tasks.

One significant supply chain challenge is properly incorporating third-party providers, such as manufacturing companies, focused on primary and secondary packaging of investigational medicinal products (IMPs) and other clinical trial materials (CTMs). Insufficient connections and non-existent manufacturing supply strategy could delay production timelines and potentially lead to considerable overspending. Inadequate product quantities or manufacturing capacities when needed are often the result of an improper planning process. This could increase costs along the entire clinical supply chain and raise the likelihood of study delays.

There are essential supply chain elements to consider when integrating third-party providers, especially with contract manufacturing organizations (CMOs), as well as best practices to improve information flow among clinical, logistics, manufacturing and IT teams.

Favorable clinical trials are those having a positive effect on the tested substance. Certainly, patient safety is a key focus. Formulation of the investigational product, its stability and all associated packaging aspects are essential in this regard. Sometimes good manufacturing practice (GMP) efforts to finish a product are underestimated by clinical R&D personnel. The only appropriate response for CMOs is to consistently educate sponsors and CRO stakeholders. Implementation of robust quality/technical agreements should be a given.

Recognizing the highest impact and importance of quality within the supply chain is a basic but often neglected element. Without an elaborated quality management mindset that embraces the supply chain, a clinical trial may not be successful. Quality does not start or finish with product manufacturing, however, it is one essential part that should never be omitted. The final study result is valuable only when all processes have been developed well in advance and when all possible known consequences have been thoroughly considered. The awareness of the field of work in which we are operating must be omnipresent and repeatedly verified.

Who has not experienced the bullwhip effect in clinical supply chains? Due to limited transparency of demands along the supply chain — from the patient, investigator, clinical monitor, local depot, central distribution center, CMO or third party vendor involved in pre-production activities — last-minute orders or misuse of available stock hinders trial continuity and produces considerable inventory swings. This can not only have dramatic cost implications, but may also impact safety. Patients already enrolled into a clinical trial can be put at risk if not supplied with sufficient trial medication on time.

To make clinical logistics more efficient, one must understand the dependencies and evaluate and mitigate associated risks in advance. A single weak link in the chain can cause the entire ensemble to break.

Clinical supply planners are challenged with evaluating several aspects during the start-up phase, however, they often find themselves disconnected from the clinical team. Since CMOs are involved early in the supply chain stage of production, it is essential to embed manufacturing experts into the clinical trial core planning structure. CMOs must know the expected delivery time to sites and patients, as well as the required quantity and availability of the initial IMP batch. Likewise, they must have information about drug product shelf life and stability, which are essential for expiry management and drug handling at sites/patients.

A forward-looking distribution strategy includes the entire manufacturing element as part of the overall plan, forming a coherent, logical process long before packaging is complete. Expiry date management and distribution schemes should also be factored into the strategy. Packaging and label design, plus the impact of product characteristics — dosage form, temperature conditions — must also be considered.

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