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Challenges Facing a Preclinical CRO Part 2: Deadlines


Adhering to a tight schedule is a reality that most contract research organizations (CROs) will face in the preclinical phase of drug development. Managing sponsor expectations and completing the work within strict time, cost and quality constraints can be a challenge and requires adequate experience and resources to succeed.

Communicate/Manage expectations

Even early on in the project planning stage, both sponsor and CRO can be proactive at mitigating communication fails by ensuring that expectations and responsibilities are explicitly outlined for all team members. The sponsor should communicate company policies and standards explicitly and in writing whenever possible to the contract facility prior to beginning the project. For example, if the sponsor prefers data formatted in a certain way or described in specific language, it is important that the sponsor delineates that up front. A responsive CRO will take heed and ensure that deliverables are structured accordingly. The following issues should be outlined in advanced and communicated clearly to all team members:

  • Deadlines
  • Interim meetings dates (including expectations of progress at each step)
  • Key personnel (responsibilities and contact information)
  • Software
  • Compliance and quality requirements
  • Anticipated results
  • Absolute requirements for success

Metrics for meeting timelines

Careful planning is your best tool for ensuring timely deliverables. Anticipating exactly when you will need to receive animals or specific consumables and then verifying the items are available is essential. A CRO that is managing several projects that rely on the same skilled people or essential technologies can sometimes struggle with this level of cross-client organization.

Having a checklist in place that will verify the availability of all the necessary staff and equipment can also help to establish successful time management. If you discover several weeks in advance that your veterinary pathologist will be preoccupied with another project during the study report-writing phase of the project, for example, you have time to reorganize the workload so as not to sacrifice the quality or deadline.

A weekly meeting is another effective way to get a snapshot of progress without micromanaging the technical staff excessively.

Finally, a predefined contingency plan should be in place and communicated to all team members so that when one of your metrics alerts you to a problem, everyone is on the same page in terms of keeping the project on track.

Software/technology for data access

The most efficient software for laboratory information management should accelerate workflow and allow easy access to the information required to facilitate critical decision-making by scientists. It should be flexible and work with the technology and equipment being utilized by the laboratory.

Implementing a new software system requires time and may cause an interruption in workflow while personnel adjust and learn to apply the technology. However, it can also be a wise time-investment, increasing capacity to collect, access and retrieve data smoothly and efficiently. Sometimes a CRO will struggle along, relying on antiquated software that is no longer suitable for its use just to avoid a bumpy transition. Once an appropriate and efficient technical solution is in place, however, the efficiency and timesaving benefits will outweigh any transitory costs.


Another challenge arises for the busy CRO that takes on too many studies without having the appropriate space and/or staff available to ensure high quality science. Sometimes availability is difficult to assess at the onset of a project. It is not easy to say “no” to a client who wants to place a study or studies with you. That is when having an outsourcing partner with whom you are confident can deliver high quality services is essential. Outsourcing some of the work to a reliable, quality contract facility before letting the projects slip off the timeline is in everyone’s favor. Remember, sacrificing quality for timeliness will not satisfy your clients. Sometimes delegating particular responsibilities allows for concentrated effort on areas of strength, meeting client expectations of quality AND timeline.

So, if you are struggling to meet a deadline because you’re understaffed or overbooked, outsource your histopathology!

If you find that there is just not enough room in your facility? Outsource long-term archiving!

« Go back to Challenges Facing a Preclinical CRO Part 1: Quality

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