Direct-to-patient (therapy)
The ability to expedite enrollment and retain patients throughout your clinical trial is key to the efficient commercialization and clinical development of your therapy. Ultimately, compressing a therapy's time in development can allow sponsor companies to better allocate resources and ensure patient populations throughout the world receive the treatment they need. That’s why pharmaceutical companies continue to look for more patient-centric solutions to attract and retain participants. A direct-to/from-patient (DTP/DFP) model is one such solution, adding convenience for patients who are unable or unwilling to travel to testing sites as well as extending your reach to include patients in remote areas who might not otherwise have been able to participate in your trial.
Direct-from-patient (samples)
Adding a DTP/DFP methodology to clinical trials has several benefits—including expedited patient recruitment and increased patient retention. That’s why samples must be picked up from patients and delivered to central or specialty labs within a specific timeframe—often in coordination with a home health nurse collecting samples. Biological samples are also temperature-sensitive and often require an understanding of dangerous goods and customs regulations expertise to ensure the proper classification, packaging and labeling.
Direct-to-patient (medical devices)
From blood glucose monitors and pulse oximeters to portable EKG machines—at-home medical devices can be lifesaving. These types of devices are also perfect for direct-to-patient (DTP) clinical trials, giving you access to a wider, more diverse range of participants from all parts of the world. Our team of experts will develop a plan with an individual supply chain for each DTP shipment designed to get your medical device shipments to patients as quickly as possible to keep your clinical trial moving.
Here are some of the features we offer:
- A market-leading online IT platform, QuickOnline 2.0, with the ability to blind patient data combined with project management tools such as real-time shipment monitoring and status alerts.
- Access to certified dangerous goods specialists, if needed, with an in-depth knowledge of international laws around shipping hazardous materials.
- Clinical trial materials delivered to the patient’s home within product specifications and time constraints in coordination with the home health nurse or patient for administration of investigational drugs.
- Door-to-door route planning and real-time GPS tracking to ensure clinical trial materials are delivered to the patient's home within product specifications, with contingency planning in place to stay ahead of potential delays.
- Expert temperature-controlled logistics for all temperature ranges from refrigerated (2-8ºC) to controlled room temperature (CRT, 15-25ºC) and beyond.
- In-transit storage (cold room) using GDP principles and best practices as well as ability to re-ice dry ice shipments in transit.
- Packaging, sourcing and consultation on active and passive systems, placing and retrieving monitoring devices.
- Return pick-up and delivery of biological specimens from the patient's home to central or specialty labs for testing and compiling data.
- Strict adherence to patient privacy combined with a proven knowledge of HIPPA and GPDR compliance.
- Strict and transparent chain of custody to ensure all samples collected are properly labeled and tracked throughout the entire process, from collection to analysis, so that they can be correctly matched to the correct patient and trial.
- End-to-end logistics plan that includes supply chain design, as well as temperature monitoring throughout the entire shipping process.
- Comprehensive regulatory support, including brokerage services, consultation on country-specific customs and airline restrictions, to ensure that trial materials and specimens are properly packaged and classified.