We have assembled a team of experienced readers, both in Europe and US, with a proven and comprehensive track record in several therapeutic areas.
All readers assigned to the review of data collected during a study meet the following requirements:
Prior extensive experience with data reading (>5 years) including knowledge and familiarity with clinical trial good practices and regulatory requirements,
Prior specific experience in performing the ECG or imaging analyses required as per protocol (according to Banook Group SOPs for physician qualification).
Our board-certified experts deliver a timely, accurate, and comprehensive analysis of all clinical data. Each new member of the readers’ team receives extensive and rigorous training in image reading, clinical trial requirements and data management procedures and timelines with the main objectiveto reduce variability in data assessments throughout study conduct.
Our standard process is to involve one or more reading teams in the study depending on the size of the study, its design and the defined timelines. Upon request, we can involve our medical reviewers in the data readings as adjudicators, more particularly to review pre-specified alerts.