The Authors describe how they used a standard database management system (System 2000) and a computer utility to build a sophisticated medical records system in support of a national multi-clinic clinical trial. Privacy, protocol adherence, quality control and other key elements of an ethical clini...
Data management for a large collaborative clinical trial (Cass: Coronary artery surgery study). Comput. Biomed. Res. 11:553–566, 1978.Kronmal RA, Davis K, Fisher LD, Jones RA, Gillespie MJ: Data management for a large collaborative clinical trial (CASS: Coro- nary Artery Surgery Study)....
Clinical trials constitute a key source of medical research and are therefore conducted on a regular basis at university hospitals. The professional execution of trials requires, among other things, a repertoire of tools that support efficient data management. Tasks that are essential for efficient dat...
Class I medical devices are subject to product filing management, and clinical trials are not required, but clinical evaluation data need to be submitted; when Class II and III medical devices are registered , clinical trials should be conducted (except for medical devices in ...
for data management activities within a clinical trial, according to regulations, applicable Standard Operating Procedures (SOPs) and Processes. 4.Works with the global study team to meet the study objectives. Primary Responsibilities General 1.Ensure that all data components are conducted in compliance...
The Study Data Manager (SDM) is responsible for supporting quality deliverables of data management activities for clinical trial including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensure activities are completed according to agreed standards and timelines...
industry-leading technology partners substantiated by solid records in the field, allowing us to provide the right solutions for each trial and every sponsor. Our stellar data-management services—and therefore your study’s success—is based on these cloud-based Electronic Data Capture (EDC) ...
DSG offers a comprehensive fully integrated suite of EDC clinical trial and decentralized trial software, and data management services for all bio-tech and life sciences industries.
Database lock (also known as data lock, or DBL) is a critical step in clinical trial data management which occurs after trial data has been collected, verified, and cleaned. Database lock is the process of approving and finalizing the completed data set, and “locking it” to further chang...
Zelta, a cloud-based unified clinical data management and acquisition platform with customizable modules, can be tailored to the meet the unique needs of your clinical trials – providing more control and confidence over your trial outcomes. Learn more about the platform 500+ PHASE III TRIALS...