1

Project Management (PM)

A clinical leader needed transparency to his portfolio of global studies and proactively manage resources, timelines and budgets.

2

Change Management (CM)

Humor was used to facilitate change management to a project centric culture.

3

Trial Master File (TMF) Inspection

A team was hired to evaluate TMF as part of due diligence on a potential acquisition.

4

Regulatory Inspection Preparation

A team of experts was hired to prepare for regulatory inspection of sponsor Trial Master Files (TMF) and investigator sites.

5

Standard Operating Procedure (SOP)

Sponsor company needed to revise SOPs to reflect their current procedures and personnel.

6

Expedite Enrollment

Clinical study team needed to increase enrollment rate in order to complete the study on schedule. A root cause analyses (RCA) helped find the shortest path to completion.

7

Just in Time (JIT) Staffing

Staffing with consultants can be a JIT model on clinical staffing.

8

Missing Samples

Clinical samples were lost during a clinical trial and not discovered until late in the study. Several corrective actions were implemented to address multiple root causes for missing samples.