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Discovery & Development Clinical Trials, Contract Development Services, Contract Manufacturing Services

Manage the Relationship

Outsourcing certain services to competent business partners is often essential to securing value in drug development. The idea behind outsourcing is to reduce costs and increase efficiency by hiring experts who can do the job in less time, with less costs, and to a high standard of quality. It sounds straightforward, but management conflicts and mistrust in the relationship – commonly encountered in outsourcing partnerships – can counteract these goals. Relationship management is incredibly important in the outsourcing relationship and I believe that the industry must learn to set adequate performance metrics that not only reflect milestone achievements within a set timeframe, but further extend to measure the quality of the work in terms of issue management and efficiency.

Long-term strategic partnerships seem to better deal with relationship management aspects because of the commitment and mutual risk sharing.

According to Jean Toth-Allen, “Quality is characterized by the ability to effectively and efficiently answer the intended question about the benefits and risks of a medical product (therapeutic or diagnostic) procedure, while ensuring protection of human subjects” (1). Quality is the main goal in our industry. Quality is constantly at risk during drug development and when conducting clinical trials, whether managed in-house or outsourced. However, there are methods and techniques that can address these risks – and these should be agreed upon at the start of a contract services relationship. In particular, teams need to be supported in dealing with the real-life challenges and issues that emerge during the course of the relationship. I specialize in clinical trials – here, the human element is vital. All issues in clinical trials are usually directly or indirectly related to human interaction. Unfortunately, I find that this element is often neglected and left to the individuals managing the contracts to attend to without sufficient support. These individuals may not have any experience in relationship management, or may be ill resourced and overworked (increasingly common in today’s economical environment), which leads to relationship management falling between the cracks. This major deficiency must be addressed at both the sponsor and service provider ends. Long-term strategic partnerships seem to better deal with relationship management aspects because of the commitment and mutual risk sharing. But not all companies are able to form (and sometimes do not require) long-term relationships.

Outsourcing, whether short or long term, must be seen as a relationship between human beings that do not always share the same values, culture, visions, objectives, and practices. One party fills the other’s gap, but for the piece to truly fit the puzzle, the various differences need to be thoroughly identified, discussed and aligned. Falling short in giving the human element of the relationship due attention and care will inevitably lead to delays, inconsistencies, and relationship failure, which will damage the outcome in one way or another. 

The industry is not aligned on vendor management expectations outside of deliverables and milestone definitions.

The industry is not aligned on vendor management expectations outside of deliverables and milestone definitions. In my view, we need an industry tool that addresses and defines the key aspects of the sponsor/contractor relationship required for success. Ideally, such a tool would include clearly defined issue resolution scenarios and escalation paths for CRO performance problems (vendor managers must be involved and trained accordingly). A strong structure must also be in place to encourage a shift in mindset related to vendor oversight – namely, a solid multiple level governance system. In addition, sponsor in-house teams must be trained on managing outsourcing partners on a cooperation level rather than just focusing on deliverables and timelines. The overall aim is to educate companies about the important role that human factors play in the success or failure of outsourcing.

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  1. U.S. Food & Drug Administration, “CDER small business webinar on building quality into clinical trials – an FDA perspective – May 14, 2012” (2012). Available at: Accessed: November 12, 2017.
About the Author
Muna Kugler

Muna Kugler is Global Strategic Sourcing Manager, Idorsia Pharmaceuticals, Switzerland.

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