Clinical Data Management
Successful R&D relies on the accurate interpretation of quality data. Data management maximizes data integrity and quality by focusing on accuracy, consistency and accountability. Throughout the clinical trial process, the Clinical Data Management group at Global IQ works closely with the client on all aspects of a trial from design and protocol development through to analysis, reporting and submission.
Electronic tools including SAS and our proprietary electronic data capture (EDC) system are used to ensure the accuracy of the data, shorten the query processing cycle and reduce the time from last patient, last visit to database lock.
The Global IQ data management process features:
- Document tracking
- Electronic data capture, double data entry or a combination tailored for the specific study
- Protocol specific data management and validation planning and data handling conventions
- Dictionary implementation and maintenance. Coding of medical terms such as medical history, adverse events and concomitant medications
- Data review listings
The clinical data management group comprises:
- Clinical Data Scientists
Responsible for database design and programming, data review
- Clinical Data Associates
Responsible for data entry and management, including tracking, data validation, query management and associated documentation
- Clinical Data Assistants
Responsible for data entry, data monitoring, tracking and quality control.
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Bruce Leisen, BSc Director, Clinical Data Management Edmonton, Canada |
Bruce brings 19 years of combined experience from both clinical research and R&D settings to the Global IQ team. Bruce ensures that his team’s duties are carried out to exacting standards. Bruce manages resources and addresses any issues to prevent negative impacts on project timelines. He develops, implements, and coordinates effective internal and external communication strategies to maintain effective project management. Bruce writes, reviews, and/or approves changes to the clinical trials process (including SOPs). He also responds to clients’ data-related concerns and participates in audits amongst other important duties. Outside of work, Bruce enjoys golfing and coaching hockey.
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