Evidence-based medicine, virtual trials, a patient-centric industry focus, the increased development of orphan-drug candidates and the focus on specific patient populations, such as pediatric or elderly patients, are driving the growth of DTP service offerings.
Clinical trials are more frequently being brought straight to the doorsteps of their participants, allowing patients to receive clinical trial materials at home, and have blood samples drawn and prepared for shipment through a home care nursing network. These DTP services can include the delivery of drug products and supplies, along with the pick-up of biological samples. Since 2012, Marken has managed global DTP trials, with the largest trials including over 15,000 patients; it currently supports DTP services that involve more than 1,600 investigator sites in 46 locations worldwide.
Trial-specific clinical supply chains must be appropriately designed and established, particularly for advanced therapies and personalised medicines. As a result of this, establishing a unique chain of identity for each patient is essential. Interactions between the various points in the supply chain, and particularly between the clinical trial supply chain solution provider and all involved partners, are crucial. Only logistics providers with extensive knowledge, experience and effective supporting technologies can meet these constantly evolving and increasingly complex needs.
In order to ensure the most efficient - and easiest - way to work with Marken globally, the company launched Allegro, which is an online rule-based booking tool that allows investigator sites to book any kind of shipment from a smartphone or computer, while maintaining compliance with all of the rules and conditions defined for each specific trial. The demand for Allegro is continuously growing and the tool is available in several languages.
In April 2017, Marken launched its Patient Communications Center (PCC) in Philadelphia, US, which is a 24/7 call centre that is dedicated to meeting the logistics needs of patients who are participating in home-based clinical trials. Marken's call centre further enhances their home service by allowing patients to contact a specialist to schedule a pick-up or delivery and discuss any specificities related to the logistics process. Marken's Patient Communications Center specialists are trained for each clinical protocol, providing instructions to the company's operators and drivers for each patient and delivery. Marken works with its clients, such as global pharmaceutical and biotech companies, clinical research organisations (CROs), contract manufacturing organisations (CMOs) and central laboratories to ensure strict compliance with each clinical protocol. In June 2017, Marken launched its DTP White Book Industry Guide, a client resource that provides clear logistics standards for DTP trials.
Tracking and the management of supply chain data is also enhanced, resulting in improved supply chain intelligence that allows for the optimisation of material deliveries and cost reductions. The GPS-enabled Marken device, Sentry, performs real-time tracking of a package's location and condition, as well as communicating with shippers and receivers.
In 2016, Marken established a new global control centre in Mumbai, India. The control centre monitors shipments to all of Marken's regions across the globe. The centre transmits data through its proprietary Maestro operating system that is backed by the Marken Sentry tracking device, providing real-time coverage of shipment location and temperature.
Marken's unique blend of expertise has grown from its ability to attract highly experienced and proficient experts from a variety of CROs, CMOs and other logistics providers, which has fuelled the company's growth to more than 800 employees in over 46 locations. A flexible global network ensures the seamless flow of shipments and information. This includes the reduction of waste and inefficiencies in the supply chain, despite increasing and varied customs regulations. State-of-the-art information, inventory, temperature control and other technologies enable the patient-focused delivery of clinical trial materials to any location in the world, on time and within specifications.