Simplifying Clinical Data Management With a Comprehensive Ecosystem

Clinical Data Management (CDM) has the important role of ensuring high-quality, reliable and statistically sound data across all clinical trial phases. Yet, the process is more complex than a simple review of the data. Trial data should be cleaned and standardized throughout the study instead of only at study close-out.

To efficiently accomplish quality data review in a timely manner, a comprehensive data management ecosystem is essential. Such an ecosystem incorporates an experienced team, best-practice guidelines, standard templates, medical coding tools, standard operating procedures and more. In addition, seamless integration between electronic data capture (EDC) and other systems simplifies the data management process.

Speakers

Renee Selby, Senior Clinical Data Manager, Bioclinica

Renee Selby is a skilled Senior/Lead Clinical Data Manager with over 20 years of experience in various roles within Clinical Data Management, with the last eight years specifically working as Clinical Data Manager and Senior/Lead Clinical Data Manager. Working for CROs and Functional Services Providers (FSP), Selby has vast experience in managing multiple Clinical Research studies within a wide-ranging group of therapeutic areas and Electronic Data Collection systems. She serves as the technical leader covering all data management aspects for studies including start-up, maintenance and completion phases of a study. She is excited about Clinical Data Management and is currently working on expanding her knowledge by attending and presenting in industry forums to gain shared knowledge and ideas on how to take Clinical Data Management to the next level. Currently she is working as a Senior Clinical Data Manager with Bioclinica and is based in Bioclinica’s New London, Connecticut office.

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Lisa Carlson, Manager, Clinical Data Management, Bioclinica

Lisa Carlson is an experienced Clinical Data Manager, having managed personnel within Clinical Data Management for 17 years and having over 21 years of experience in Clinical Data Management services, covering all aspects ranging from study start-up to study close-out activities. These activities include, but are not limited to, design and implementation of the electronic data capture system, edit check and programmatic listing design, preparing study specific documentation such as the DMP and documents covering external vendor data requirements, data entry, ongoing maintenance of data cleaning, external data reconciliation, medical coding, metric reporting, site closeout and Quality Control. Her entire clinical career has been spent working for CROs and Functional Services Providers for a wide variety of Pharmaceutical companies. She excels at simultaneously managing multiple clinical studies and multiple clients. She works very closely with the pharmaceutical teams as a partner ensuring the finest quality data possible. Her strong communication skills help enhance all client relationships. She is very passionate about Clinical Data Management and is especially looking forward in this ever-changing world of technology. Currently she is working as a Manager, Clinical Data Management with Bioclinica and is based in New London, Connecticut.

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