Operating clinical trials in the Covid-19 climate

Abi Pesun, director at Almac ONE explains how a shift towards unified supply chain management can accelerate timelines and help mitigate risk for clinical trials during Covid-19.

In light of the global pandemic, sponsors are having to strategically re-evaluate their R&D pipelines and decide whether or not planned clinical trials can go ahead in existing timeframes and if existing trials can continue in their current scope of work, due to in-country restrictions globally. For sponsors conducting Covid-19 studies, they need to decide whether to re-prioritise over existing studies and if so, they have to set up with accelerated timelines, due to the urgent need to establish drug efficacy in prevention or treatment of the virus.

With so much new and additional disruption and complexity to navigate, designing and maintaining streamlined clinical supply chains that safeguard timely, compliant and cost-effective drug production and distribution to patients matters more than ever.

Identifying the blackhole

Yet, if supply chains are fragmented, the heightened risk Covid-19 presents can escalate further. If the physical supply chain (the network of manufacturing facilities, buildings, warehouses, trucks, planes and people through which drugs are produced and distributed) fails to align with the digital supply chain (the systems that capture, store and disseminate supply chain data to power, monitor and track ordering, movement and administration of clinical supplies) the opportunity for error, delay and negative patient impact multiplies. 

Typically, sponsors outsource the management of the physical and digital supply chain to separate vendors. This can create an unintentional yet inevitable void between the two disciplines; a blackhole where vital study data can be lost, errors breed and the opportunity for process automation and continuous improvement missed. The outcome of all of this is fragmented, at times unresponsive, cumbersome and error-prone supply chains that cause delay and disruption to a sponsor’s ability to safely and cost-effectively deliver the right drugs to patients at the right time, place and temperature.

For sponsors needing to amend protocols to accommodate evolving requirements caused by the pandemic, the lack of speed and agility offered by such disparate systems, processes and suppliers can make change slow and difficult to achieve. 

Prioritising time and resource

This fragmented way of working also demands excessive time and resources from sponsor teams, who need to piece disparate data together, liaise between multiple vendors to set expectations, troubleshoot issues and negotiate resolutions. With Covid-19 forcing many sponsors to proactively re-evaluate R&D pipelines and existing supply chains, there is renewed emphasis on the importance of appropriate time and resource allocation. The ability to prioritise core, strategic activity that champions business continuity will be afforded to sponsors that aren’t restricted by traditional vendor management models but can instead reliably handover clinical supply set up and maintenance tasks to a single vendor with dual expertise.

Bridging the physical and digital divide

To create agile and effective operations, the gap between the physical and digital supply chain must be bridged. The primary way to achieve this is by utilising a single vendor with the dual expertise and capability to create one harmonised operation that unifies the physical supply chain with the technology that underpins it. Through a strategically developed single set of processes, combined with proven closed loop technology (mutual recognition procedure (MRP), interactive response technology (IRT), event related potential (ERP), forecasting and temperature management systems), data can be effectively managed, end-to-end, to provide greater visibility and control from production line to patient.

Access to dual expertise in clinical supplies and technology all under the same vendor roof, results in a typical five-fold reduction in errors when releasing inventory and raising shipment orders; requires less time and resource from sponsors; delivers process automation to drive efficiency and offers a unified view of data, which facilitates smart decision-making and continuous improvement.

Achieving seamless and streamlined supply chains

Utilising a single vendor model with dual expertise across clinical supplies and technology, better supports sponsors to effectively respond to the supply chain challenges and constraints caused by the shifting clinical trials’ landscape; culminating in a seamless and streamlined supply chain experience during the Covid-19 climate and beyond.

Established, pre-validated processes and procedures translate into faster yet highly controlled, physical and digital supply chain set up. This removes delays that typically manifest when multiple vendors are involved and need to input into interdependent tasks, such as IRT design and physical supply chain planning. For all sponsors, especially those initiating Covid-19 studies, the ability to set-up core functions at rapid pace to align with ambitious study start dates is imperative. Indeed, utilising a unified supply chain strategy has supported reduced study set up time for several sponsors, with one Covid-19 trial sponsor up and running in two and a half weeks. Timelines that are inconceivable with a fragmented approach, yet have the potential to facilitate urgent scientific breakthroughs.

By unifying the supply chain, sponsors can effectively manage changing study supply strategies, reprioritise deliverables and manage the wider business impact of the pandemic. Equally, by removing the data blackhole that exists in a multi-vendor model, a ‘right first time’ ethos can be established that mitigates error and delay. Instead, key experts across supply chain management, manufacturing and logistics can work in partnership, uninhibited by the constrictions of a multi-vendor model and with a common goal, to ensure alignment between physical processes and the supporting technology.

A new benchmark for future preparedness

During the current climate, this means packaging and distribution strategies can be rapidly aligned with any changes required in the IRT and protocol amendments, required to assure resupply to active patients despite quarantines and site closures, can be effectively integrated within the physical and digital supply chains.

The shift in how clinical trials have been conducted in the past few decades has been significant. Complex therapeutic areas, globalisation of clinical trials and the increase in regulatory requirements to name but a few mean sponsors must continue to evolve their operations to keep pace with new demands. Covid-19 represents an extension of this evolution, as sponsors recognise the restrictions siloed supply chains have on their ability to respond with speed and precision to urgent demand and effectively manage risk.