A key aspect of clinical development and clinical trial operational success is getting the data right. Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses the importance of Data Management, the Statistical Programming and Analysis, and the Quality Assurance activities.

I previously discussed clinical trial operational success from the viewpoint of Getting the Right Data, which involves site selection, clinical assessments, laboratory procedures, clinical supplies and biological specimens. Last week I discussed Getting the Data Right, which encompassed Case Report Form (CRF) design and clinical monitoring. This week I will discuss data management, statistical programming and analysis, and quality assurance.

Data Management

Data management transforms raw Case Report Form (CRF) data into the electronic version that can be ordered, organized, reorganized, transferred, analyzed and archived. Data professionals are responsible for ongoing quality checks, query generation and resolution. It is their job to ensure the integrity of the clinical data as it undergoes its transformation from CRFs to complete data sets that can be then subjected to extensive statistical analysis.

Statistical Programming and Analysis

The biostatistician oversees the processes that group, summarize, analyze, and otherwise present trial data for clinical interpretation. These processes often include statistical computer programming as well as development of the analysis plan, conduct of primary and exploratory analyses, and preparation of data tables, listings, and figures for display and communication.  The project statisticians, in conjunction with the clinical team, produce the final study report, an interpretive document whose validity rests, once again, on maintaining the integrity of the clinical data at every step in the process.

Quality Assurance

Quality assurance activities permeate the clinical data pathway. Whether conducted by professionals within each department, or by an independent department (or even contractors), quality assurance checks and extensive audits further increase confidence that each datum in the final database can be traced with accuracy to its counterpart at the clinical site. In critical situations – most commonly, Phase 3 trials generating pivotal efficacy data for registration purposes – the audit process is extended externally to include key clinical investigative sites as well.

These final phases of the clinical trial process are critical to ensure one is ready to interpret the data. The source of the data has to be confirmed, properly recorded and assigned to appropriate fields within the database, before the statistical program is run. After several further checks, the final step prior to interpretation of the data is the so called  “data lock”, when the data set is finalized and locked so it can no longer be changed, corrected, or moved to different places. It is this “locked data” which is then interpreted.

Dr Michael Silverman is the principal clinical consultant at BioStrategics Consulting Ltd., a clinical development consulting company based in Marblehead, MA, with business interests around the globe. Dr Silverman would be delighted to hear your thoughts on today’s blog, your experiences, or anecdotes and of course, your questions. To make comments or ask questions, click on this link.



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BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical, biotechnology and medical device industries, including: Clinical development strategy and management, conceptualization, implementation, and management of Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials, IND planning and preparation, FDA and other regulatory authority submissions, meetings, and related interactions, Clinical strategic planning for small molecules, biotechnology products, immunotherapeutic agents, novel drug delivery technologies, and medical devices in virtually all therapeutic areas, New technology assessment, due diligence, and program planning, Clinical development advisory services to senior-level management (CEO, COO, CSO, BOD).

Copyright © 2011 BioStrategics Consulting Ltd.


About BioStrategics Consulting Ltd

BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical and biotechnology industries
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