PPD Review: Neonatology – Critical Care Study

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PPD
929 North Front Street
Wilmington, NC 28401-3331
United States
(910) 251-0081
http://www.ppdi.com

Neonatology – Critical Care Study

 
Overall: 3 stars

Date: June 24, 2014

Proposal Quality:
 
4
Ease of Contracting Process:
 
2
Comprehensive Solution:
 
3
Experience With Study Type:
 
3
Therapeutic Area Expertise:
 
2
Project Management:
 
3
Responsiveness:
 
3
Problem Solving:
 
4
Adherence to Timelines:
 
3
Adherence to Proposed Budget:
 
2
Reporting Quality / Data Accuracy:
 
3
Value (Price vs Quality):
 
3
Strength as a Partner:
 
3
Willingness to Recommend CRO:
 
3
 

Service Description

Tasked to ensure timely enrollment of the study, also to have monitoring of the data and high quality timely data retrieval from sites.

What Went Well

The enrollment after a slow start, picked up and the study was completed on time. Regarding monitoring and quality of data, again, after initial hiccups, they were able to change the team (CRAs) and refreshed the training resulting in high quality data

What Could Be Improved

Monitoring of the data is an example. Initially lots of queries and missing data, not handled properly. Resulting in some CRAs changed on team and than two refresher trainings conducted. also decrease the number of sites per CRA from 8 to 5 helped.

Lessons Learned from the Experience

Most of the thinking was aligned, where its typically to have changes on team if one CRA doesnt have the right background or has issues in terms of site relationship. Similarly the travel schedule etc eased a bit after they reduced the site burden.