Gathering, analyzing, and presenting the data to support life-altering new medicines for people around the world is a long, complex, and detailed process. Most of us know that this data is collected from clinical trial research – but how do contract research organizations gather all that data and compile it in a way that is clear, accurate, and complete? With the efforts of the Data Management team, of course!
Data Management professionals are typically involved in clinical trial design and conduct from the very beginning. They provide invaluable knowledge and understanding into the optimal study design that collects the data elements the drug developer needs to support a regulatory submission. They maintain a holistic view of the processes and practices, keeping in mind the clinicians who will ultimately use the data, and also the biostatisticians, clinic staff, medical writers, and others who gather and analyze it. They make sure the study is designed to measure what it needs to measure, and the data is structured so that it can be clearly presented to regulatory authorities’ requirements.
Data Managers are responsible for the design of the case report form (CRF) and relational database used to collect, store, extract, and report on clinical trial data. A relational database organizes data points with defined relationships for easy access, so that complex queries can be used to evaluate and analyze the data. CRF and database design are vital; ensuring that all the relevant parameters are available to allow meaningful analysis.
As an entirely hypothetical example, we may want to analyze an observed effect by gender and age. We may want to further refine based on blood pressure reading, to see if the effect is more common in those with high blood pressure. Such analysis requires that the data points by which we wish to refine are captured on the CRF and exist in the database. The CRF and database design processes involve collaboration with many internal stakeholders, such as biostatistics, clinic staff, and study scientists (pharmacokinetics [PK] and pharmacodynamics [PD]).
Throughout the trial conduct, the Data Manager works with the clinical sites to ensure that the data is complete, accurate, and submitted in a timely fashion. Data that is being captured for additional assessments at other sites or by study subjects at home must also be tracked and reconciled. Missing or unclear data entries have to be flagged during review, and followed up with the clinical site for clarification or correction, to ensure the complete reliability of the final database.
Data Management professionals are key to ensuring robust, quality data for scientific analysis, and preparation of the clinical study report, or CSR. Global regulatory bodies require adherence to strict standards for the electronic submission of data, which “enable(s) the accessibility, interoperability, and reusability of data”1 in clinical research. Data Managers make sure those requirements are respected. Their deep commitment to your studies ensures that your drug applications are comprehensive, thorough, and supported by the highest quality data.
Altasciences offers Data Management services on a stand-alone basis for trials conducted at other clinical sites, on a full-time equivalent (FTE) basis, or as part of a complete package of services with us.
Contact our experts today to discuss how we can meet your Data Management needs.