Clinical Trial Drug Distribution and Logistics
Biologics is an established leader in the management, storage and distribution of biologicals and pharmaceuticals in all phases of clinical trials and post-market studies.
As specialty drug experts, we understand the complexities associated with these new medicines.
We understand that the ultimate efficacy of modern medicines and the accuracy of clinical data depend on how these agents are packaged, stored and shipped. We offer a highly trained and qualified clinical staff, a state-of-the-art facility and guaranteed delivery.
We provide custom distribution and logistics solutions to CROs, cooperative groups, manufacturers and other professional research organizations as part of the pharmacy component of the protocol. We provide cost-effective solutions tailored each project. Our scaleable clinical trial business unit is designed to meet your budget, time and distribution needs.
Whatever your drug distribution and logistics needs, we’ll develop a plan to ensure a successful open label, single-blind or double-blind clinical trial.
Arm protection
We establish custom procedures to protect the identity of each arm of the study.
Budget details
Biologics provides a working budget for consideration based on the current protocol and a new one for each amendment if you decide, for example, to increase enrollment or add arms. You will know exactly how much drug distribution and logistics will cost, and we can tailor the distribution and logistical plans to meet your budget needs.
Clinical supply management
We stock the clinical supplies necessary to dispense the drug. And we provide reconciliation and disposal services available for returned medical supplies.
Close-out audit
At the end of the study, we’ll work with you to coordinate a Close-out Audit that will provide you with detailed distribution documentation including balances, logs and ins/outs that will add validity to your study.
Compounding
We can compound sterile, intravenous medications.
Customized packaging
Multiple pills of various strengths might comprise one dose. We’ll package each dose individually to eliminate confusion for the patient and ensure accuracy and safety.
Custom shipping
Drugs are shipped in temperature-controlled packages to protect the integrity of the drug. We can facilitate shipping needs to meet budget and time requirements. And we electronically track all shipments.
Drug Acquisition
Biologics will negotiate and manage the acquisition of the drug.
One source
All of your drugs are stored in the same environment eliminating temperature and handling variables that could impact the outcome of the study. We store and deliver the drug to the institutions with patients enrolled in the trial. This reduces the risk of improper storage and dispensing. We’ll coordinate shipping with the practice to ensure on-time delivery.
Patient enrollment processing and database development
We coordinate new patient enrollment throughout the study with the registrar while protecting the blind. We maintain a database of patients and to which arm of the study they’re randomized. These records are available to the registrar to maintain checks and balances of patient enrollment, the amount of drug distributed, and shipping information.
Placebo management
Biologics will facilitate the acquisition of the placebo, ensuring its appearance and packaging are consistent with the drug itself. Often this process might involve having a placebo manufactured or over-encapsulated to look the same as the trial drug.
Pharmacy support
Our pharmacists are on call 24 hours a day, 7 days a week to answer questions. And we are DEA licensed for C1-C5 narcotics.
Protocol review
Biologics will review your protocol and make recommendations for cost-effective drug distribution and logistics.
Unblinding
Should the need arise, we offer immediate emergency unblinding upon request.
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