Insights Blog

DIRECT-TO-PATIENT LIMITS COVID-19 DISRUPTION

With the COVID-19 pandemic disrupting every facet of life, patients participating in a clinical trial have to deal with a whole new set of fears: not knowing if they will receive the medication on time (or at all), the risk of being exposed to the virus at traditional clinical trial centres, etc. Clinigen Clinical Supplies Management is committed to helping mitigate the risk of COVID-19 on clinical trials and supporting patients.

We are partnering with one of our clients to support a study for the prevention and treatment of the novel coronavirus. Using our Direct-to-Patient (DtP) model, we are treating this project with utmost urgency, and are happy to apply our expertise for the benefit of patients in these difficult times.

Our innovative Direct-to-Patient platform is a patient-centric approach to clinical supplies in which the supplies are prepared, packaged, labelled, and then shipped directly to the patient's or caregiver's home. Our DtP logistics pre-planning ensures that products are delivered at the right time, at the right temperature, and within the right guidelines, even in these unprecedented times.

We are currently supporting multiple sponsors to adapt their ongoing studies with our Direct-to-Patient services, in order to avoid disruption due to COVID-19. A traditional clinical trial can be turned into a DtP trial, either partly or completely. We have extensive experience in shipping the medication directly from the drug depot to the patient’s home, lessening the impact on sites such as hospitals that are under pressure from the current crisis. We also provide site to patient shipments, and can adapt your trial quickly, as needed.

With our agile global capabilities and expertise, we understand the needs of clinical trial sponsors and their patients, and can coordinate DtP trials and ensure their success.

 

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DIRECT-TO-PATIENT ALLOWED IN THE EU

Within the current regulatory framework, Direct-to-Patient (DtP) shipments have limitations in Europe. However, in light of the COVID-19 pandemic, DtP investigational medicinal product (IMP) delivery from site to trial participant is now accepted in several EU member states. Even DtP from depots to patients has been accepted by authorities in rare cases when justified.

 

STRONG EXPERTISE IN MANAGING DTP TRIALS

We have over a decade of experience working together with many trial sponsors, couriers, and clinical sites managing Direct-to-Patient studies, and have delivered over 7,000 DtP shipments to trial participants.

With our traditional clinical supply services, shipping from depot to site, and DtP shipments from the depot to the patient’s home or the site to the patient’s home, we are perfectly positioned to ensure trial success even in these challenging times. Our expertise in depot to patient shipments enables us to ensure that patients receive their medication and remain healthy, with much less impact on the site. We are agile and can quickly adapt a trial to suit the needs of the trial sponsor, site and the patient.

How can we help your project ?

Speak to a Clinical Supplies Management expert to discover how our Direct-to-Patient distribution can help you avoid clinical trial disruption and continue to make a difference in patients' lives.

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As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.