Covid-19 poses an unprecedented threat to the continuity of supply of vital medications to patients enrolled in clinical trials around the world. To rise to the rapidly developing clinical supply chain challenges caused by this global pandemic, sponsors are reviewing protocols, seeking expert guidance from their contract development and manufacturing organization (CDMO) and acting with agility by implementing necessary strategic actions.
 
Quarantines, travel restrictions, site closures and limited site personnel, are some of the factors contributing to this increased level of risk, which is presenting unprecedented challenges to those tasked with delivering the right drug to patients, at the right time and at the right temperature. Sponsors and their partners are working closely to ensure patients receive their treatments amidst changing circumstances and increasing restrictions. Delays are not an option and it is mission critical to deliver for patients. There are several key strategies for companies involved in the clinical supply chain.
 
Supply chain agility
 
The close dialog and established processes between sponsor and supporting CDMO organizations will facilitate monitoring of the status of clinical sites and patients activities that will drive actions across the supply chain. For instance, there may be changes in patient recruitment levels, study start-up activities, maintenance requirements and possible changes to the timelines for key protocol milestones.
 
This will drive a managed and agile approach to clinical supply inventory strategies i.e. shipping to sites, stock held at sites or changes to the overall quantities of supply. Incorporation and alignment of supply chain managers, IRT/IXRS project staff and sponsor clinical professionals is essential, as they will be able to adjust these parameters to facilitate the fluctuations in patient availability during the COVID pandemic. Supply chain managers will also provide alternative solutions to particular study considerations—such as switching to a just-in time approach for packaging of supplies that is more in line with “on demand” need at the patient level.
 
Disruption demands distribution flexibility
 
Direct to patient via site
Given Covid-19 and the acceleration of this pandemic, increasing numbers of patients are unable to travel to site due to Government restrictions on movement. In cases where patients can no longer travel to site, a Direct to Patient via Site model ensures continuity of drug supply to the patient’s home. This service provides for patients that have critical needs, leveraging mechanisms typically employed in normal circumstances when patients cannot visit clinical sites due to, for example, their age, illness or proximity.
 
Although a DTP via Site distribution model may represent a feasible solution for many sponsors, its viability will depend on several factors, including participating countries. Many EU nations, the USA and China support the DTP via Site model, yet a significant number of countries do not. With the landscape changing so rapidly, prioritizing access to real time information is key. As such, sponsors should seek expert guidance from their CDMO partners.
 
CDMO to patient                                                                                                                                                                   
If the clinical site has closed or key staff are no longer able to travel to a site due to an increase in restrictions and lockdowns, a CDMO to Patient distribution solution may be utilized. In the challenging scenario where a site may be closed, supplies are shipped to the patient’s home directly from its CDMO facility without compromising product integrity and ensuring GxP compliance throughout. Additionally, some regulatory authorities are evolving their trial management criteria in order to facilitate this solution under specific conditions. The regulators such as the FDA and MHRA are becoming more open minded to alternative approach to ensure the patient is at the forefront of any actions or decisions made. By combining experienced project management and reliable courier services, the delivery of essential clinical supplies to patients globally is maintained.
 
Site supportive strategies
 
Remote drug monitoring
As many clinical studies require a blinded/unblinded monitor to visit the clinical sites, this can be very challenging if at all possible during this pandemic. For an active clinical study, it is essential that the participating sites are compliant with the dosing requirements of the trial. Dosing and dispensation records can be reviewed remotely to ensure accuracy and completeness. A remote drug monitoring approach can eliminate the need for the Clinical Research Monitor to visit the site and the paperwork and procedures provided can assist in organizing the documentation at the clinical site.
 
Temperature control
Sponsors need to ensure the quality and integrity of the drug product throughout the supply chain and the journey of any temperature controlled pharmaceutical product needs the perfect environment to ensure efficacy. Regulations require the sponsor to provide proof the drug product remained within the labelled temperature conditions from manufacturing through to the clinical site. An end-to-end temperature management strategy provides the assurance that medication is fit for use, that all temperature data is collated, stored, and accessible to the sponsor and the material is available for dispensing to the patient.
 
Business continuity and risk mitigation
All the response strategies outlined rely on the bedrock of an effective Business Continuity Plan. This ensures the health and wellbeing of personnel, suppliers and vendors, site operations and the minimization of risk to business operations. An effective Business Continuity Plan also safeguards the management of resources to ensure quality, capacities and service levels are maintained for sponsors. This provides sponsors with the assurance of a managed response to the evolving situation, clear lines of communication, information and promotion of close dialogue to ensure the timely provision of clinical materials. This also provides a platform for supply chain flexibility that can be infused across all studies as they react to changing recruitment and site supply strategies, alongside any changing “on the ground” realities led by the Governments and local Health Authorities worldwide.
 
Safeguard timely, compliant and cost-effective patient supply
 
We live in unprecedented, uncertain, challenging and concerning times. As great members of our general public the world over are becoming patients due to the Coronavirus, sponsors are not only providing for existing patients on active clinical trials but also moving to accelerate the commencement of new trials. This is part of the wider research drive they are involved in to find a vaccine/treatment for Covid-19, requiring increasing supply chain flexibility and novel approaches from all partners involved in the clinical supply chain.
 

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Sharon Courtney is Almac’s Logistics Services Manager. She is an international logistics specialist having worked for 18 years in clinical supply chain operations. She has expert knowledge in a number of key areas within the end to end supply chain process including management and control of temperature sensitive shipments; risk mitigation; developing and managing robust relationships with transport partners; chain of custody responsibilities; active and passive shipping solutions and import/export country knowledge.