Choosing the Right Clinical Trial Packaging Partner: The 5 Cs to Consider
Chris Ellis, Business Development Director, CTS
Today’s clinical studies are increasingly complex and ever-changing, and they demand flexible clinical trial services (CTS). Because of this, looking for an alternative packaging partner could seem daunting. Here are some things to consider if switching packaging partners is on your to-do list:
The 5 Cs to Consider when Changing Packaging CDMOs
- Capabilities – Identify a CDMO partner with the capabilities you need to complete your drug packaging project successfully. Remember, technical abilities are only part of the process when assessing a prospective CDMO partner. Determine if you will have access to SMEs, preferably in-house, to assist and answer any questions you may have during your project!
- Capacity – Capacity restraints for clinical trial supply projects have become an issue throughout the industry, especially in the post-covid era. The restrictions have a domino effect, and longer lead times can result in delays and missed milestones critical to your project’s packaging and release. Be sure you clearly understand their capacity availability and backlog.
- Compliance – Patient and facility compliance is very important for designing your package and ensuring the facility you work with follows the FDA guidelines. Be sure they follow the latest quality standards and procedures and have a history of favorable audits by customers and agencies.
- Communication – Transparent and consistent communication through your project timeline is critical to the success of your project. From the RFP to the release of your clinical product, you must be aware of your project’s problems and progress.
- Cost – Cost is an essential consideration for any project. The cost of changing vendors is broken down into two distinct costs – physical and time. Physical cost refers to the money spent traveling to a prospective CDMO to perform an audit, technical site visit, or any other part of the vetting process that has a monetary cost. Time cost is more literal and is defined by the time it takes to go through the logistics. For example, this can include CDAs, MSAs, legal reviews, etc. Because you want to pick the best partner for your project, you can’t afford to skip any part of the vetting process to avoid these costs.
Regardless of your company’s size or project, Societal™ CDMO is the right company for you. Societal is a full-service clinical CTS vendor with primary and secondary packaging, global storage, and distribution capabilities. We have open capacity at each facility and purpose-built packaging rooms to increase our ability to support our end-to-end solution and standalone packaging. Customers and various government agencies have successfully audited these packaging suites, guaranteeing that your packaging will be produced to the highest quality standards.
Societal embraces a team approach to ensure the success of each project. You will have a team dedicated to your project’s success throughout your project. SMEs will help develop a patient-compliant package that meets the needs of your clinical protocol. Your project manager will act on your behalf internally and provide you with consistent communication throughout the process. Additionally, they will work with the other SMEs to ensure the most effective use of your resources. l the project is completed. For more information on Societal’s CTS offering, visit our website or contact me to discuss your project details.