There are several titles used for people who manage and distribute the investigational products for clinical trials. For simplicity, we will just used the title, "Director of Clinical Research Supplies." The role of the Director of Clinical Research Packaging is to manage the supply of investigational drugs or devices for clinical trials.
The Director must work with Clinical Operations to estimate the amount of product that will be needed and then to supply and resupply each of the clinical sites. The Director will receive the randomization program from the study biostatistician. The Director must work with CMC (Chemicals, Manufacturing, and Controls) to understand the availability of investigational materials and the packaging and stability needs for the products. They must develop clinical supply packaging that takes into consideration product stability and availability, regulatory requirements, and international customs rules. They may need to coordinate production of labels, including translations if required. Then, they must prepare and ship the study supplies to the Investigative Sites.
The primary investigational product will probably come from the Study Sponsor but the packaging unit may also be responsible for purchasing and packaging the materials that will be used as placebos or active controls. They need to track and replace expiring product and manage the return and destruction of unused clinical supplies when a subject terminates from the study or when the study ends.
The Director must have an understanding of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCPs). The Director and the team may need to work with a variety of software programs including such things as voice randomization software used for randomized assignment of drug to subjects in the study and other IT systems used for forecasting drug supply and for packaging, labeling and distribution.
The Director of Packaging may be an employee of the Pharmaceutical or Device company that is sponsoring the study or they may work in a Contract Research Organization hired specifically to manage drug supply and distribution. They may have to communicate and interact with clinical teams and manufacturing teams that are located in other states or other countries.
In the early stages of clinical trials, there may be limited supplies of investigational product and the packaging team may need to find innovative ways to keep sites supplied while following all GCPs. Similarly, it is not usual to have drug supply “crises” during long term studies. The packaging team must work with clinical and manufacturing to try to prevent these problems or to adjust quickly to prevent supply problems from putting research subjects or research programs at risk. Throughout the clinical trials, the Packaging team must maintain detailed records that will be needed for clinical study reports and regulator application.
At the end of a successful clinical research program, the Packaging team usually assists Commercial Packaging in preparing for the launch of a new product.
Directors of Packaging usually have a degree in Pharmaceutical Science or Supply Chain Management or a similar field.
The Director must work with Clinical Operations to estimate the amount of product that will be needed and then to supply and resupply each of the clinical sites. The Director will receive the randomization program from the study biostatistician. The Director must work with CMC (Chemicals, Manufacturing, and Controls) to understand the availability of investigational materials and the packaging and stability needs for the products. They must develop clinical supply packaging that takes into consideration product stability and availability, regulatory requirements, and international customs rules. They may need to coordinate production of labels, including translations if required. Then, they must prepare and ship the study supplies to the Investigative Sites.
The primary investigational product will probably come from the Study Sponsor but the packaging unit may also be responsible for purchasing and packaging the materials that will be used as placebos or active controls. They need to track and replace expiring product and manage the return and destruction of unused clinical supplies when a subject terminates from the study or when the study ends.
The Director must have an understanding of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCPs). The Director and the team may need to work with a variety of software programs including such things as voice randomization software used for randomized assignment of drug to subjects in the study and other IT systems used for forecasting drug supply and for packaging, labeling and distribution.
The Director of Packaging may be an employee of the Pharmaceutical or Device company that is sponsoring the study or they may work in a Contract Research Organization hired specifically to manage drug supply and distribution. They may have to communicate and interact with clinical teams and manufacturing teams that are located in other states or other countries.
In the early stages of clinical trials, there may be limited supplies of investigational product and the packaging team may need to find innovative ways to keep sites supplied while following all GCPs. Similarly, it is not usual to have drug supply “crises” during long term studies. The packaging team must work with clinical and manufacturing to try to prevent these problems or to adjust quickly to prevent supply problems from putting research subjects or research programs at risk. Throughout the clinical trials, the Packaging team must maintain detailed records that will be needed for clinical study reports and regulator application.
At the end of a successful clinical research program, the Packaging team usually assists Commercial Packaging in preparing for the launch of a new product.
Directors of Packaging usually have a degree in Pharmaceutical Science or Supply Chain Management or a similar field.