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Selecting the best partner contract service and fostering a successful relationship requires detailed research and effective communication.
The drug license holder-contract service provider relationship can be complex, with many intricate details involving products, regulations, processes, and people. Managing this relationship can be challenging, and many drug companies are not providing adequate oversight of the outsourcing organizations that are providing mission-critical services for their drug development projects.
Likewise, contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs/CMOs) must have suitable communication processes in place to work effectively with their clients. Roger Hayes, senior vice-president of DMPK, MPI Research, shared his thoughts about the drug company-outsourcing relationship with Pharmaceutical Technology magazine.
PharmTech: Recent merger/acquisition activity has resulted in consolidation in the contract services market and the rise of ‘one-stop-shop’ operations. What are the advantages and disadvantages of working with a single-source provider? What are the advantages and disadvantages of working with a contract service provider that specializes in just a few areas?
Hayes: Consolidation has become the norm as research organizations attempt to define themselves in this fast-paced industry in which science quickly advances and new technologies are being developed regularly.
Working with a single-source provider streamlines the process and simplifies the experience for sponsors. A full-service provider offers access to a broad range of experienced teams and scientists that can weigh in on challenges or unforeseen circumstances. Larger CROs also have the expertise to understand the necessary elements and compliance required to bring a drug or device through each stage of development.
However, niche operations with a complete dedication to certain specialized areas also have a role. There is value in longstanding operations that are established experts in their field. These organizations have their limitations, including size, capabilities, capacity, service offerings, and experience in other scientific areas that may play a role in the particular study.
PharmTech: What challenges exist when a drug license holder contracts with multiple outsourcing organizations on a single project?
Hayes: Enlisting multiple partners to undertake one project could potentially result in a complex environment, and require managing several moving parts. Different CROs may have different approaches to information sharing, goal setting, and reporting. A clear plan for success has to be defined at the onset and ongoing communication and alignment between all parties is absolutely necessary.
PharmTech: What assessment approach should drug companies take to determine if they need to outsource a project or specific function?
Hayes: Sponsors can determine if they need to outsource by identifying whether or not they have the resources to undertake the project at hand. Many drug companies don’t ever intend to conduct studies in-house based on the core focus of their business. Larger pharma companies typically decide to outsource services if they don’t currently have the required capacity, or if they don’t have the necessary specialized and regulatory expertise in-house.
The resources and management required to conduct preclinical studies are significant, and CROs offer the ability to start studies in a timely fashion. CROs have deep expertise, established protocols, and internal oversight (i.e., the Institutional Animal Care and Use Committee) that ensure all stages of the study are conducted in compliance with the strict regulatory guidelines.
These advantages result in efficiencies for the sponsor that allow studies to advance at a faster pace.
PharmTech: How can CROs and drug companies assess if they are a good match for each other?
Hayes: Choose your partners wisely and don’t rush your decision. While several factors play into the selection, it’s important to choose a CRO partner based on quality, time, and cost, with emphasis on the first two. Also, it’s beneficial for sponsors to work with CROs that employ a consultative model. In an industry that evolves as quickly as ours, it pays (literally) to work with people who understand the practical details of new technologies and regulations. Take the time to ensure your development team not only knows ‘letter of the law’ regarding requirements, but also has a practical understanding of how to navigate the real-world process. A little experience can and will have a significant impact on your timeline, budget, and chances for success.
PharmTech: What can be done to improve the outsourcing and client relationship?
Hayes: The relationship between the sponsor and CRO can be complicated, but with collaboration and a clear definition of responsibilities and expectations, these relationships can be highly effective. Communication is the primary key to a successful partnership. To ensure a positive relationship, all team members should understand expectations and deliverables at the onset.
A realistic timeline should be developed and agreed upon, taking into consideration any areas of potential delay. It’s important for CROs to recognize the limitations of their team and set realistic expectations to mitigate the chance for dissatisfaction. Finally, CROs should connect with their partners often--not only if mistakes or delays occur, but also when things are going well. The more information, understanding, and respect shared between both parties, the more successful the project.
Pharmaceutical TechnologyPartnerships in Outsourcing Supplement 2017
When referring to this article, please cite it as "What Works Best in Pharma-CRO Relationships?," Pharmaceutical Technology, Partnerships in Outsourcing Supplement 2017.