A newly expanded Direct-to-Patient service offering supports decentralized clinical trials to minimize clinical trial length and costs while maximizing patient enrollment and participation rates. The comprehensive offering now includes Clinical Site-to-Patient, Pharmacy-to-Patient, and Depot-to-Patient services to enable clinical trial medication delivered directly to patients’ homes.
Thermo Fisher Scientific’s expanded Direct-to-Patient services build on its global Clinical Site-to-Patient program that launched earlier this year to ensure clinical trial patients have uninterrupted access to life-saving investigational drug shipments without having to visit a clinic. The program can support any trial phase and a range of trial variables, including Interactive Response Technology (IRT) systems, blinded or unblinded, and home nursing providers. Clinical Site-to-Patient services are available in 47 countries and have supported more than 1,500 shipments to patients worldwide to help treat more than 25 different indications.
“Decentralized clinical trials have been on the rise even before the Covid-19 pandemic due to the location of study centers and the amount of time required for study visits being barriers to patient enrollment and ongoing participation,” said Chris Armstrong, president, clinical trials business, Thermo Fisher Scientific. “As patients increasingly reach out to clinical trials sponsors to request receiving medication at home, it’s critical to have a solution that delivers patients’ medications safely and on time, without compromising trial quality and speed.”
Thermo Fisher’s Direct-to-Patient service offering includes
- Pharmacy-to-Patient and Depot-to-Patient services enable centralized control and simplified supply chain planning in managing high-value or limited supply agents available in all 50 US states. Investigational Medicinal Products (IMP) and non-IMP drugs are shipped directly to patients’ homes from either a pharmacy or central depot site using a GMP-compliant clinical supply chain system and coordinated through Thermo Fisher’s HIPAA- and GDPR-compliant Direct-to-Patient contact center and Patheon Logistics.
- The Clinical Site-to-Patient service leverages Thermo Fisher’s Total Transportation Management capabilities, choosing the best option to deliver the medications directly to patients’ homes or study sites, enabling maximum patient compliance. Moreover, Thermo Fisher offers the ability to ship to 47 countries approved and vetted by our regulatory experts, reducing timelines and cost for study sponsors.
- Through the Direct-to-Patient solutions, Thermo Fisher provides expertise across the full supply chain, including support for ancillary sourcing, blinding, patient kit production, clinical supply optimization, and decentralized clinical trial setups.
- Thermo Fisher provides additional services for patients participating in hybrid or virtual trials, such as coordination with home nurses.
- Direct-to-Patient also offers end-to-end cold chain management and traceability and centralized storage of clinical trial material, reducing waste and minimizing the storage space needed at clinical sites.