No More Missed Milestones: The Benefits of Clinical Trial Materials and Clinical Trial Supplies Consolidation
By Brittany L. Hayes, Ph.D., Director, Applied Technology
Increased competition, advanced technology, and the need to operate as efficiently as possible have prompted pharmaceutical companies of all sizes to outsource more business functions. However, rather than improving efficiency, outsourcing in a fragmented way has the opposite effect: It complicates communication and project management, possibly leading to missed milestones, delayed timelines, and compromised quality.
Consolidating the manufacturing of clinical trial materials with clinical packaging, labeling and distribution services makes collaboration with suppliers easier and more effective. Here, we detail the financial, quality, and project management benefits of this end to end consolidation.
- Comprehensive, end-to-end clinical trial coverage. The manufacturing of clinical materials are often siloed processes from primary packaging and labeling. This break in process leads to inefficiencies in workflow not to mention communication breakdown. With an integrated approach, moving seamlessly from clinical manufacturing into packaging, the sponsor receives comprehensive, efficient coverage across the broad spectrum of services needed to supply materials for clinical trials.
- One supplier, one contact. As pharma companies lean more heavily on external partners, many of them contract with separate suppliers for toxicology, clinical research, formulation development, manufacturing, packaging/labeling, and distribution, among other activities. When you consolidate those activities with one supplier, you eliminate numerous administrative and project management headaches. This frees up your team to focus on higher-level tasks.
The power of one includes the following:
- One supplier to manage (one master services agreement simplifies contracting and invoicing).
- One quality agreement and quality system for streamlined quality audits.
- One project manager. Your single point-of-contact oversees all development, manufacturing, packaging/labeling, and distribution activities and timelines. Your project manager ensures all timelines are met and all milestones are achieved. And if you have a question, you know who to call.
- Initiate activities simultaneously. When working with one CDMO, you can initiate activities in parallel, ensuring you complete all tasks on time. When contracting with multiple service providers, each supplier launches projects at different times, increasing risk of delay and miscommunication.
- Improve communication. All service lines within a full-service CDMO are part of one comprehensive team. A team under one roof exchanges information more efficiently than between multiple companies in multiple time zones. For example, the packaging group knows when manufacturing is delayed and responds accordingly. When the clinical trials materials are ready, they’ll be ready. When working with multiple suppliers, your project may end up bottlenecked because your packaging supplier is booked six months out.
- No tech transfer of analytical methods. Best practices call for as few tech transfers as possible. When you work with one CDMO manufacturing through distribution, you reduce the time and money spent with another tech transfer..
- No shipping delays. You don’t have to ship your manufactured clinical trial materials to another supplier for packaging or distribution, which removes transportation costs and potential delays. You also eliminate the risk of your materials taking excursions outside of its controlled temperature environment.
- Decreased stock-out risk. An end-to-end CDMO can facilitate demand forecasting to maintain proper stock levels.
- Consistent documentation style. Using the same template structure(s) throughout development and manufacturing, packaging, and distribution can improve project management (internally and externally) as well as make the preparation of regulatory submissions more efficient.
What to Look for in a CDMO Provider
When you partner with one CDMO for manufacturing, packaging, labeling and distribution of your clinical trial materials, you get the financial, operational, and clinical benefits described above. Look for a partner with specialized expertise from development to commercialization, whether that’s in new dosage forms or with extended release products.
To avoid late-stage complications, look for a supplier that can provide integrated regulatory support from the start. That regulatory partnership will help streamline your product’s pathway from IND to NDA to regulatory approval, whether you’re submitting to the FDA, or a foreign health ministry.
A single-source CDMO provider must also have the equipment and facilities, including a cGMP validated and monitored warehouse, to manage your project. Validated, dedicated temperature storage areas for drugs, drug components, and ancillary materials—with security—will ensure your products are safely stored at the optimum temperature.
Save multiple hours per week by reducing time spent managing and communicating with multiple suppliers. Finish projects at or under budget. Hit your milestones. That’s what you can expect when you consolidate from multiple suppliers to one.
To find out how Societal CDMO™ can assist from pre-IND to commercial supply, speak with one of our experts today.