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Catalent, a clinical supply service, has announced the launch ofFlexDirect, a new direct-to-patient service for clinical trials. The FlexDirect service provides sponsors with the choice of site-to-patient distribution, or Catalent’s new pharmacy-to-patient service, both of which can be combined with standard distribution of clinical supplies to offer a customized hybrid approach as needed. Catalent’s pharmacy service is located within the same facility as standard distribution, enabling clinical supplies distributed to both clinical sites and directly to patients to originate from a single location, eliminating the need to maintain separate inventories.
The FlexDirect service offers benefits to both sponsors and patients undertaking clinical trials. For sponsors, direct-to-patient distribution of clinical supplies (patient kits) supports improved recruitment and retention of patients by delivering treatments directly to their homes, removing barriers such as transportation challenges and addressing the constraints of underlying health conditions that may hinder patients’ visits to clinical sites. The service also makes trials more patient-centric by improving convenience, supporting busy lifestyles and reducing the number of clinical visits that are necessary. Site-to-patient services are available in the U.S. and Europe. Pharmacy-to-patient services are accessible in the U.S. via Catalent’s on-site pharmacy at its Philadelphia location, offering sponsors a streamlined and compliant solution that eliminates the need for clinical sites to physically receive, store and dispense patient kits.
“The nature of clinical trials has evolved, but the needs for a trial to maintain patient engagement and ensure dosing regimens are adhered to remain paramount, and direct-to-patient supply reduces the burden of patients to visit clinical sites and maintain participation,” explained Kristen DeVito, Global Director Clinical Supply Services. “FlexDirect increases the options available to study sponsors and offers increased flexibility in distribution, reducing the strain on clinical sites by offering a pharmacy-based service and promoting patient retention.”
The Philadelphia facility is the largest site in Catalent’s global clinical supply network, and in 2018, celebrated 20 years of operations. Originally constructed in 1969, the facility was renovated in November 1998 to add clinical packaging, storage and distribution capabilities to the commercial packaging service already in place. Since then, it has increased its storage and distribution capacity and grown from 45,000 to 200,000 square feet. In April 2019, a $5.5 million expansion program at the site was completed, offering increased storage space, additional cold chain packaging areas, and a new clinical label design and printing area.