Since CSM became part of Clinigen Group in 2018, we have been working as one, delivering end-to-end clinical trial services. With our combined expertise in the packaging and labeling of clinical trial material and the sourcing of comparator drugs, we partner with our clients and leave no stone unturned to research and deliver the best solution for each challenge.
We recently started supporting a large Phase III study in Europe that illustrates our ability to use our expertise in providing a customized and integrated service solution. Our client, a non-profit academic organization with limited regulatory or framework knowledge, required the sourcing of an existing product as well as packaging and labeling for an add-on therapy trial. This three year multi-country study for a combination of compounds required significant drug volume.
The Clinigen difference
Our clinical supplies expertise in packaging and labeling combined with comparator sourcing knowledge and a large global supplier network enabled us to provide the full end-to-end integrated solution to the customer.
As a single service provider, we offer a one-stop-shop customized solution. We assign one contact person to the client for their project, ensuring a personalized service, and building a strong customer relationship.
We looked at the whole solution regarding the type of product that was needed, evaluated different options, including generics, and ultimately opting to buy a branded product.
The importance of teamwork
Our customized solution was a team effort and required a lot of internal collaboration and alignment. Different parts of the business came together to develop the solution for our client, together with the client.
From the sales director who acted as the facilitator and the good relationship with the client, to project management, our legal department that negotiated three-way contracts, our consultative sourcing approach, and the quality department, everything played an important part.
The preparation took over a year due to the complexity. We provided the client several options, multiple possibilities, taking their needs into careful consideration.
Our combined end-to-end services
Together, our packaging & labeling and comparator sourcing experts applied a consultative approach. We did our due diligence on the regulatory framework, researching the options with regard to branded vs. generic products both in terms of regulations and price, reviewing all the details to support the client.
We have all licenses in place needed both for packaging and labeling and dealing with wholesale pharmaceutical products. We worked together with a manufacturer that we already had a long-standing relationship with, having put in place similar types of agreements and contractual negotiations already.
With the good relationship we had built with the client in the past, and our excellent supplier relationships, we were able to navigate the complexity of the study and develop the right tailored approach.
We have twenty-plus years of clinical trial packaging and labeling experience and provide the flexibility and agility needed to ensure the success of even the most complex trial setups.
As for comparator product sourcing, we have in-depth knowledge and established relationships across the manufacturer landscape, and our robust sourcing procedures guarantee product integrity. In the last five years alone, we have sourced and delivered 2.5m units, including 7,000+ different products across 13,000 orders.
Our custom approach means we always find a way to get the job done.
How can we help your project?
Speak to a Clinical Supplies Management expert to learn more about our combined services.