Case Study 5: Client Audit - Frequent Database Locks - Tight Timelines

The Challenge

A blue chip pharmaceutical company transferred the management of a multi-centre trial to BELTAS at trial Initiation. As part of their CRO qualifying processes, BELTAS and two New Zealand (NZ) sites were audited by the client shortly after the transfer. In the first 12 months of the trial, frequent monitoring and repeated tight timelines were to be met for worldwide data collection, including four data base locks. Several sites in NZ had high patient numbers.

The Response

> Frequent monitoring, Database locks

1. During this very busy 12-month period, one of our experienced SCRA’s was the main point of contact. Assigning an experienced SCRA provided stability for both the sites and the client and provided an efficient and consistent workflow.

2. Our SCRA worked very closely with the client project team as well as the sites, and supported sites with their time management.

3. An open, goal-oriented and enthusiastic communication style allowed all parties to organise and plan their equally tight timelines.

> Client audit

4. Internal processes were clear, well organized and documented in SOPs and guidance documents, for the auditor to follow.

5. BELTAS staff set up trial processes at site initiation, collected and tracked essential documents for the regulatory binders, and maintained the files at each monitoring visit.

6. All our S/CRA’s are ACRP certified and strive for a high clinical trial standard. We not only identify any quality gaps at site, but resolve and train site staff as part of monitoring visits.

The Results

• All deadlines were met in time and to the client’s satisfaction
• For one or more of the database locks, NZ was the first of nine participating countries to have all required data entered in the system, all DCFs resolved and data frozen.
• BELTAS and the two sites passed the audit with no observations or open recommendations.

Client Feedback

"This is not an easy study, we are pushing CRAs a lot because of very strict timelines and we are very demanding. We are very pleased with the way you handle things to make all the work done within the timelines and with your enthusiastic approach and dedication to this project."
- Client Project Team Leader

"You have shown already many times that there are no impossible timelines for you!! "

- Client Study Manager