Clinical Trial Logistics and Services
FFF Enterprises, Inc. (“FFF”) provides management and support for clinical trials through distribution and supply chain logistics and services. We are recognized by the National Association of Boards of Pharmacy as a Verified-Accredited Wholesale Distributor. FFF has participated in more than 30 clinical trials, supporting the sponsors ranging from IVIG, Albumin and Factors, to West Nile Virus, C-1 Inhibitors, Plasminogen, Varicella Zoster Immune Globulin and Non-Hodgkin’s lymphoma therapy. Other areas of expertise include:
- Participation in studies for efficacy, safety, tolerability and access to pharmacokinetic (PK) profile
- Experience in distributing investigational products for comparator studies
- Our regulatory services team verifies site licensing on required documentation for all imported trial products. We also require approvals and documents for export to Canada, and are a Customs Bond Holder.
Distribution and Storage Services
- Our dedicated clinical support and operations staff, which includes our Project Manager, Logistics Manager, and Customer Service team, are part of a group of professionally trained staff who manages materials, including drug product and ancillary supplies, to ensure accurate quantities are packaged and shipped to clinical sites.
- We are compliant with all external audit requirements, both domestic and international.
- Additionally, we are experienced in importing product from the U.K., Canada and the European Union.
- Our state-of-the-art storage facility located in Temecula, California is equipped with temperature controlled and monitored (ambient and refrigerated) equipment.
- It is also a GMP and 21 CFR 205 compliant facility with secured access.
- Our facility provides and supports product return, recall and destruction services.
- Additionally, our facility manages delivery expectations to clinical sites by patient or in bulk shipments.
Verified Inventory Program™
- Our Verified Inventory Program (VIP) offers medical grade cabinets that are equipped with radio frequency identification (RFID)-powered technology to enable FFF, the sponsor and the CRO to remotely monitor investigational products.
- VIP cabinets are temperature controlled for either refrigerated
(2° C to 8° C) or room temperature product storage.
- The cabinets are available in four different sizes:
- 2.3 cu ft.
- 5.2 cu ft.
- 12 cu ft.
- 26 cu ft.
VIP Alerts and Reports
- VIP provides real-time inventory alerts and immediate notification when temperatures fluctuate out of specifications, protecting product integrity.
- Alerts and reports include:
- Periodic Automatic Replenishment (PAR) level alerts
- Temperature alerts
- Expiration date report
- Inventory report (quantities and lots)
- Customized usage reports
NuFACTOR® Specialty Pharmacy
NuFACTOR, the specialty pharmacy of FFF Enterprises, Inc., offers comprehensive pharmacy services and specializes in the treatment of patients with chronic conditions with concentration on rare disease states in neurology, immunology, hematology, oncology, dermatology and rheumatology. NuFACTOR has the ability to both monitor and promote clinical trial compliance so that the sponsor and the CRO’s resources are not wasted.
- Through NuFACTOR, FFF has the ability to deliver products to physician offices and ambulatory infusion clinics.
- NuFACTOR also offers clinical product distribution to a patients’ home and/or office.
- On-call pharmacists and nurses are available 24/7/365 to help answer clinical questions or concerns.
- Customized reporting is available to the sponsor and the CRO upon request.
- Through FFF, NuFACTOR also offers Lot-Track® product tracking and recall notifications.
- Our in-house Marketing team has the ability to create specialized educational patient materials for the sponsored study.
- NuFACTOR has earned the Joint Commission Gold Seal of Approval and is a URAC Accredited Specialty Pharmacy.
For more information regarding Clinical Trial Logistics and Services, contact Bob Vega at (800) 843-7477, ext. 1127.