Project And Data Management
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SOCAR offers comprehensive study management services, including logistical study
management, management of clinical trial safety information and data management
services.
Logistical study management
Efficient management of the logistical aspects of a clinical trial, including
developing a strong working relationship with each site, is crucial for the
success of the clinical trial. The logistical management services
offered include:
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Project planning
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Set-up and organisation (scientific and logistical) of expert meetings, round table discussions
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Set-up and organisation (scientific and logistical) of committee meetings
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Site identification and selection
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Training of study personnel (Clinical Research Associates, site staff)
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On-site visits (consisting of pre-initiation, initiation, on-site monitoring and close-out visits)
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Management and tracking of study medication supplies
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Management of essential documents
Data management
During the design phase, we work closely with our client to create a study-specific
high-quality database and efficient data management process that complies with
ICH-GCP guidelines and FDA 21CFR Part 11. The data management services
offered include:
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Design, development and implementation of the study database
(paper based or electronic data capture) according to client specifications
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Testing and validation of the study-specific database according to
well-documented procedures and in accordance with ICH-GCP guidelines and
FDA 21CFR Part 11
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First and second data entry (for paper-based clinical trials)
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Query resolution and management
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Quality Assurance and Quality Control
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Data tracking
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Data coding of (serious) adverse events and concomitant treatments
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