Optimizing clinical trial data management

12th August 2015 (Last Updated July 16th, 2018 10:10)

Noelle Alexandre, Senior Manager - Data Management at BMS Belgium, explains the benefits of data management and the important role of data managers in clinical trials to save time and be more efficient.

Optimizing clinical trial data management

CTA: What are the best practices you are implementing to collect and manage data?

NA: In BMS we are quite advanced in standardization. We have standard collection instruments that we can use again and again instead of re-inventing instruments every time we want to collect data. We have a lot of standards, and not only do we standardize the instruments to collect the data but all the tools to review, clean and report the data are also standardised.

CTA: What are the benefits of standardization as opposed to other procedures?

NA: We improve the overall quality and uniformity of the information collected, processed and reported to regulatory agencies, and by utilizing data collection, cleaning and reporting models we reduce start-up and review times. We have been working with standards for the past 15 years.

CTA: Are there any challenges of working with standardized procedures?

NA: It's a double-edged sword: by reusing global standards we can gain time but the process in itself takes time when updating or creating new standards. The ultimate goal is to create regulatory submissions that can be easily interpreted and navigated by regulatory reviewers, using certain formats and rules. There are some specific domains that have no standards yet and then we have to work with the regulators to make sure that we submit the data in the format that they want. That is time consuming.

CTA: Any suggestions that would help improve the process of data management?

NA: Yes, data managers should be involved earlier in the game, i.e. participating in the protocol writing.

CTA: How would this ease your work?

NA: I will give an example; sometimes the protocol requests for vital signs to be collected but doesn't specify which ones. When building the CRF/database we have to ask the clinicians which vital signs they want, what is the frequency that they are looking for and so on. If data managers would sit next to the clinicians during the time they write the protocol, we could be more precise and we would save time as we would not have to come back to them afterwards asking some more questions. It is a matter of efficiency.

CTA: What is needed to get data managers more involved in the process?

NA: For people to recognise that we can bring our expertise to the table and the advantages this would provide in the long run

CTA: How do you think data managers can gain recognition?

NA: We should lobby more, become more a presence and participate in decision meetings, both internally and externally.