Almac’s global facilities remain open and operational since the initial outbreak of COVID-19 (Coronavirus). Currently, Almac Clinical Services has not experienced any significant operational impact due to the Coronavirus outbreak and our service levels remain unchanged. As the situation evolves, we continue to ensure successful drug delivery to patients for ongoing clinical trials worldwide.
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Supporting your clinical trials through COVID-19
In each territory where Almac operates and classification has been defined by local authorities, Almac is recognised as an “essential” or “life-sustaining” business. As the global spread of COVID-19 escalates and local and national governments enhance restrictions on people’s movements, we assure you that due to the essential nature of the work we carry out, Almac will continue to conduct critical business operations and our staff will continue to support your supply chain. We are living and working in uncertain, unprecedented and unpredictable times. The health and safety of our employees and our ability to ensure the delivery of medicines for our clients to their patients is our priority.
Almac Business Continuity
Upon declaration by the World Health Organisation (WHO) of this situation in late January, Almac Clinical Services enacted its Business Continuity Plan, which ensures the health and well being of personnel, suppliers and vendors, site operations and the minimisation of risk to business operations, as well as management of resources and quality to ensure our capacities and service levels are maintained for clients. Measures introduced include:
- Review of all staffing arrangements and shift patterns to ensure that Almac resource and capacity is maximized.
- Introduction of social distancing, to include a reduction of face to face meetings.
- Remote working for all employees where their role permits.
- Focus on utilizing technology to support virtual remote meetings both internally and externally.
- All employees have been issued with guidance on health & hygiene best practice and requested to report any symptoms associated with the virus immediately.
Clinical Distribution and Regional FAQs
Almac continues to ship and receive supplies globally and we strive to transport every consignment at the optimal speed using contingency plans within our business continuity response plan framework. Nevertheless, meeting new limitations set by airlines and government authorities may affect the speed and\/or cost of delivery of shipments to certain destinations. As in-country factors can rapidly change we will endeavour to keep you informed of any changes. We have developed a global shipping report providing an overview of shipping options from Almac’s global facilities including an assessment on the degree of impact to your supply chain. We hope that this will give you a quick and easy way to visualize our view of the global clinical supply chain.
NOTE: While Almac continues to monitor shipping lanes, it is important to give consideration to the ongoing status at your clinical sites including closures, limited availability of receiving personnel or restricted times of delivery. Please communicate all site limitations to Almac. Due to the changing situation, we recommend that you continue to speak directly to your Almac representative for the most current updates.
Partner Depot Management
Almac is working closely with their partner depots , receiving daily updates on operations and in country restrictions within impacted areas. Almac will continue to focus it’s efforts on building risk mitigation response plans with clients who face impacted shipments. All information obtained from the Almac Depot Network is assessed as part of the Almac BCP to identify any necessary subsequent actions or contingencies.
Direct to Patient via Site
Almac has the ability to offer and manage a global Direct to Patient via Site service option. Almac will manage this in conjunction with our qualified premium transportation partners. This service includes the supply of the Almac Pod™ shipping system and a temperature monitor. However, due to the ongoing travel restrictions within certain in-country areas and clinical site closures, Almac will develop customised Direct to Patient via Site strategies with the specific sponsor and site challenges in mind. If this is an option which you would like to consider please contact your Almac representative.
Almac to Patient (ATP) Services
Almac Clinical Services is working closely with its sponsors and identifying the most appropriate distribution model for their supply chain needs to ensure patients around the world on clinical trials receive their treatments amidst ongoing changing circumstances and increasing restrictions. If a clinical site has closed or key staff are no longer able to travel to a site due to an increase in restrictions and lockdowns, our Almac to Patient distribution solution may be utilised. In the challenging scenario where a site may be closed, Almac will ship supplies to the patient’s home directly from an Almac facility without compromising product integrity and ensuring GxP compliance throughout. Combining experienced project management and reliable courier services, Almac is uniquely positioned to remove the obstacles to ensure the delivery of essential clinical supplies to patients globally. This service complements our existing Direct to Patient via Site solution, so offering further options to maintain a secure and continuous supply chain for your patients. For further information and expert guidance and support on either of these services please contact your Almac representative directly.
Site Support Services
With difficulties travelling to sites and restrictions on activities, supply chain agility remains critical at this challenging time. As such we are highlighting a number of site supportive strategies available to you to facilitate the management of your clinical supply chain and provide additional options to remove the burden on site personnel.
Remote Drug Monitoring
Many clinical studies require a monitor to visit the clinical sites (for blinded studies an unblinded monitor may be needed); this can be very challenging if at all possible during this pandemic. For an active clinical study, it is essential that participating sites are compliant with the dosing and dispensation requirements of the trial. A remote drug monitoring approach can eliminate the need for the Clinical Research Monitor to visit the site and maintains the continued flow of used CTM back to Almac for final disposition. Dosing and dispensation records can be reviewed and compared to IRT assignments remotely to ensure accuracy and completeness of documentation. The service also includes follow-up with site personnel on discrepancies to properly reconcile material and facilitate the timely return of partially used or expiring material to Almac for destruction. If our remote drug monitoring service is an option which you would like to consider please contact your Almac representative.
Managing Temperature Data at Clinical Sites
The risk of temperature excursions is highest during storage at clinical sites, which is also where temperature-related data capture and analysis processes are typically the least robust. Almac’s temperature management software TempEZ™ addresses these problems by digitising site temperature data and providing sponsors’ visibility remotely in one centralised database. The system is designed to eliminate the need for physical interaction with site personnel; clinical sites can upload data from temperature logs or temperature devices directly into TempEZ™ for Sponsors and CRAs to review, ensuring proper temperature is maintained and held accountable for accurately logging temperature data. If you would like to consider TempEZ™ please contact your Almac representative.
Our commitment to you
Now more than ever, we see the necessity of the work that you and your staff do with us in Partnering to Advance Human Health. We are in this together and committed to supporting your clinical trial needs and the patients you serve, as always. Be assured that we are working with the relevant in-country authorities to assess and monitor the supply chain situation and as events unfold we will continue to adapt our processes, policies and procedures as required. We encourage you to bring any concerns and questions directly to your Almac representative so we are able to ensure continuity of supply for you and your patients. We hope you, your family and colleagues remain safe and well throughout these challenging times.