Charles River Laboratories Review: Very please with the CRO’s performance

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Charles River Laboratories
251 Ballardvale St
Wilmington, MA 1887
United States
(877) 274-8371
http://www.criver.com

Very please with the CRO’s performance

 
Overall: 5 stars

Date: May 1, 2014

Proposal Quality:
 
5
Ease of Contracting Process:
 
3
Comprehensive Solution:
 
4
Experience With Study Type:
 
5
Therapeutic Area Expertise:
 
3
Project Management:
 
5
Responsiveness:
 
5
Problem Solving:
 
5
Adherence to Timelines:
 
4
Adherence to Proposed Budget:
 
3
Reporting Quality / Data Accuracy:
 
5
Value (Price vs Quality):
 
5
Strength as a Partner:
 
5
Willingness to Recommend CRO:
 
5
 

Service Description

The Contractor is conducting a chronic toxicokinetic study with a recovery period in primates. The principal objectives are to evaluate the safety of continuous exposure to the drug over an extended period, to evaluate the relationship of dose to exposure and toxicities and to assess the variability and linearity of pharmacokinetics over a longer time interval.The CRO was contracted to perform all in-life phases of the study, which involved dosing with a state-of-the-art drug delivery system, collection of timed PK samples during the course of the study, evaluation of safety endpoints during the study and recovery periods as well as clin path and histopathology and other special pharmacodynamic evaluations at the end of the study. The Study Director will also prepare the final study report, incorporating sub-reports supplied by the Sponsor.

What Went Well

The CRO was responsive, professional, timely, proactive and technically competent. The CRO maintained excellent communication with the Sponsor and other contractors (including PK and bioanalysis). Issues regarding some technically challenging aspects of the dosing, sample collection and processing procedures required for this study were addressed and the protocol was modified appropriately in consultation with the Sponsor. The Study Director was "on top" of the pre-study and study activities, and brought several potential problems to the Sponsor's attention that might have interfered with the proper dosing and sample collection. Although the Study Director had a week's vacation during the treatment phase, an Interim director (known to the Sponsor from previous studies) was appointed with non loss of control or communication.

What Could Be Improved

There were a number of challenges for this study, including the long duration, nature of the drug administration system, the number and timing of PK samples and the requirement for specific sample processing prior to analysis. The CRO did an excellent job of dealing with these issues and coming up with appropriate protocol modifications to make the study workable. As Sponsors, I think we learned to think ahead more for future studies in terms of the specific technical requirements of each study, and to raise these issues earlier on in the process.

Lessons Learned from the Experience

I'm not personally a fan of the "box" metaphor. However, the CRO had the experience, confidence and openness to get the required job done and to work seamlessly with us to develop a successful solutions to the problems we faced with this study. We have used this CRO in the past, so we did not learn something new about their abilities, but were very pleased that they continue to perform at this level. This study certainly emphasizes the importance of finding and working closely with a well-qualified, communicative and focused organization for any contract services.