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Jul 1, 2010 (Vol. 30, No. 13)

CRO Relationships Get More Serious

Pharma Downsizing Results in Increased Reliance on Outsourcing Partners

  • Choose Your Partner...Carefully

    Standardization of people, processes, technology, and common goals for data quality were a priority for Dr. Carberry. “There is much to consider—including patient safety, investments with vendors to ensure optimal site performance, and ensuring administrative responsibilities and documentation are properly addressed and managed proactively.”

    “You want to make sure the site generates good data, and that the vendor has the same goals of quality, oversight, and performance. Also, we do need to show that the data is valid. A lot of attention to detail must be paid; we do not want approval of our effective and safe medicines to be held hostage by a lack of quality.”

    Dr. Heyrman noted that the best outcomes happen when Daiichi develops long-term partnerships rather than one-off transactions. “We don’t concentrate on a single CRO agency; rather, we create preferred partnerships that allow us to target the right partner for the right trials. Our primary focus in conducting any clinical trial is get the job done accurately and quickly so we can get medications to patients. If we are to continue to develop innovative and life-changing medicines, we must continue to collaborate with CROs and other partners and alliances to share knowledge and best practices.”

    BeVard recommended choosing a vendor based on a company’s technical needs and business culture rather than consulting top lists for a geographic area. “Ideally, you want an organization that really knows the patient population of the place where you want to do the trial. They live there. And size matters—you want to partner with an organization that is the same relative size, as well as business culture. Your partnerships represent your company—it’s like hiring an employee, you want to make the right match.”

    “It’s important to have the right approach to working with CROs. They can be a lifeline for drug developers and it’s important to view them as an extension of your own organization, with shared goals and objectives,” said Dr. Heyrman. “We believe this approach is beneficial because it leads to better understanding of the goals and accountabilities, better coordination and alignment for functional collaboration, and increased productivity—all which can lead to better outcomes.”

  • Communication Is Essential

    “It’s important not to speak of challenges but of lessons learned,” said Dr. Carberry. “Our vendors are an integral part of our work, and we need to invest in a higher level of competency of resources and quality of site performance, and both vendors and sponsors should never lose sight of the patient. I encourage all sponsors to break down the barriers that currently exist between skill sets of vendors and sponsors. We need to have more transparency and better communication.”

    Boericke noted that developing true partnerships, establishing roles and responsibilities, and understanding the importance of the study within the portfolio helps a CRO to succeed. “When a team makes assumptions about the sponsor going into a study, that sets up false partnerships between the CRO and the sponsor. The team will fail to meet the expectations, regardless of the outcome. Although the sponsor wants competitive costs, quality and service are most important. Quality may drive costs, but the sponsor’s investment will result in high-quality output. When the processes have quality control built in, the output is always a high-quality product,” she said.

    While developing these partnerships, it’s important to align on the project goals and accountabilities up front, said Dr. Heyrman. “All parties are always eager to provide an excellent job. Therefore, simple and clear communication of expectations and execution are some of the most important aspects to guarantee a successful collaboration.”

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