Covance Review: Let the CRO know your expectations in advance.

Company Logo
Covance
210 Carnegie Center
Princeton, NJ 8540
United States
(888) 268-2623
http://www.covance.com/

Let the CRO know your expectations in advance.

 
Overall: 4 stars

Date: May 2, 2014

Proposal Quality:
 
4
Ease of Contracting Process:
 
4
Comprehensive Solution:
 
4
Experience With Study Type:
 
4
Therapeutic Area Expertise:
 
3
Project Management:
 
4
Responsiveness:
 
4
Problem Solving:
 
4
Adherence to Timelines:
 
4
Adherence to Proposed Budget:
 
4
Reporting Quality / Data Accuracy:
 
5
Value (Price vs Quality):
 
4
Strength as a Partner:
 
4
Willingness to Recommend CRO:
 
4.5
 

Service Description

Use mass spectrometry to characterize the monoclonal antibody impurities resolved by cation exchange chromatography (CEX). Provide identification and quantification of post translation modification present in each CEX fraction.

What Went Well

Covance provides very detail analytical data on charactering the impurities present in the target antibody process development. The data is clearly presented and the timeline is well met.

What Could Be Improved

The data Covance provided are based on mass only result. If more analytical technologies or more advanced mass spectrometry instrument could be used to confirm the result, the conclusion will be more convincing.

Lessons Learned from the Experience

Communication is very important when designing the study. It's essential to let the CRO know about our expectation of the data quality, timeline, format. e.g sometimes the data format that the CRO used is totally different from our own company. As we need to put all the data in one report for filing, we will have to re-format the result, to make it easier to compare with other analytical results.