January 2019

5 Keys to Set Your Contract Research Organization (CRO) Collaboration Up for Success

Author:  Kelsey Pigg, Michael Millhollen
Posted:  07 January 2019

Over the past 25 years of performing ADME/DMPK/DDI contract research, we’ve learned some key strategies to maximize the efficiency and effectiveness of our clients’ studies. Here are a few critical considerations that will help you ensure that your studies are completed on time and deliver the most accurate, relevant data.

  1. Provide the purpose and background for your study request upfront.
    When a study request is received, the first question we want to understand is “Why?” so we align ourselves with your goals for the study. Many times the study scope can be adjusted, sometimes saving cost and time, depending on the purpose of the study. In addition, sharing relevant, useful information about your compound and drug program goals may influence the design of your study and prevent the need for additional studies.
  2. Let them know of critical deadlines.
    Most CRO queue lengths depend on the natural ebb and flow of business, and we always try to work with critical deadlines to the best of our ability. That said, keep in mind that it can take up to a few months to deliver data depending on the study type. It’s understood that sometimes planning ahead is not always possible, as many study requests are data-driven or regulatory-driven. However, it is very important to be transparent about your timeline as early as possible so the CRO can adjust their personnel and resource schedules accordingly.
  3. Lay out your decision-making process.
    While your team approaches a decision on whether or not to place the work with your CRO, your CRO is putting together formal paperwork, reviewing the scientific details for the project, assessing their schedule, etc. Your CRO will not be able to simply start your study immediately, so it’s very beneficial to stay in communication with them – and that counts for delays, as well. Let’s say your internal or regulatory meeting is delayed, or you are waiting on other data to decide whether or not you will perform these particular studies, etc. – give your CRO a heads-up. That way they can stay on the same pace with you through the process and ensure they are taking the correct steps to best assist with your decision.
  4. Alert them of any and all changes as your study progresses.
    This is so important! If there is a timeline, scope, or personnel change, alert your CRO as soon as possible. The CRO may need to take a few steps on their end to accommodate, which can take time. Letting your CRO know as soon as possible is ideal so they can meet and exceed your scientific and timeline needs.
  5. Ask them questions!
    I always tell my clients that we view ourselves as an extension of your lab. Please use us for questions and to help interpret the results we provide. It’s the part of our job we love the most. When you succeed, we succeed. Utilize our experience and expertise to get the best “bang for your buck.” We are happy to help.
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