Clinical Data Management from the Ground Up

posted on December 17th 2015 in Data Talk with 0 Comments /

Clinical Data AnalysisFrom both a business and ethical perspective, involving the clinical data management (CDM) team during the beginning stages of drug development has a number of benefits. The core product from any clinical trial is the data you reap from your team’s research. Managing the collection, cleaning and analysis of clinical trial data is quite a task. Factor in compliance and regulatory standards and you’ve got your work cut out for you. Let’s look at a few ways the clinical data management team can help you conquer barriers that may have stood in your way before.

Data Quality and Integrity is the Goal

From the business-oriented point of view, the goal of conducting clinical trial research and clinical data analysis is to handover compelling evidence to regulatory bodies. The success of your hard work rests on the reliability of the data you’ve collected. While clinical data analysis happens after the data is collected, the process of clinical data management should always start at the beginning.

Planning Leads to Efficiency

When the same people managing your data throughout a clinical trial are also the people who helped design the process, everyone is on the same page right from the start. Data management starts before the study protocol is finalized. Data managers are valuable assets that can assist with protocol development. From the Case Report Form (CRF) to the Data Validation Manual (DVM), it’s imperative that these protocols are developed with the utmost care and attention to detail.

Efficiency Reduces Costs

Increasing efficiency while also ensuring data quality and integrity along the entire data management process inevitably leads to reduced costs for any given clinical trial. Standardization is a powerful tool for organizations to utilize. When you’re able to standardize technology, process and data standards, the entire process of data management flows seamlessly.

If you have any questions regarding the data management process, feel free to contact us!



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