Most CV Devices Approved by Process Does Not Require New Clinical Data
Many cardiac implantable electronic device models now in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device.
Many cardiac implantable electronic device models now in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device.
‘PerkinElmer’s Clinical Data Review analytical solution helps pharmacologists, biostatisticians and data managers to analyze clinical data easily.’
Tweet it Now
"Our Clinical Data Review solution speeds up the clinical data review process, automatically combining data to allow development team members to interactively explore information and discover new relationships. With the ability to quickly visualize and analyze data, team members can optimize the clinical trial process, focusing their efforts on obtaining insights and answers for bringing drugs and devices to market faster," said Karen Madden, President, Informatics at PerkinElmer.The Clinical Data Review solution allows dimension-free exploratory analysis on data such as adverse events, labs, concomitant medications, medical history and vital signs. Population, sub-population and patient-level data is brought together and reviewed at the presentation layer.
Contextual collaboration enables clinicians and data management to quickly identify data quality issues and perform adaptive monitoring. Customers can combine data from various clinical data sources without scripting or IT involvement.
IRBs Could Use Pre-clinical Data Better
In this week's PLoS Medicine, Jonathan Kimmelman from McGill University in Montreal, Canada and Alex London from Carnegie Mellon University in Pittsburgh, USA argue
In this week's PLoS Medicine, Jonathan Kimmelman from McGill University in Montreal, Canada and Alex London from Carnegie Mellon University in Pittsburgh, USA argue
Seeking to Build a 'learning Health Care System' Is Electronic Data Methods Research
To maximize shared experiences and learning for using electronic clinical data, researchers participate in the Electronic Data Methods (EDM) Forum.
To maximize shared experiences and learning for using electronic clinical data, researchers participate in the Electronic Data Methods (EDM) Forum.
Bioinformatics Software Tools Specially Designed By Researchers For Cancer Genomics
A new bioinformatics software tool designed to more easily identify genetic mutations responsible for cancers was developed by researchers at the Medical College of Wisconsin (MCW).
A new bioinformatics software tool designed to more easily identify genetic mutations responsible for cancers was developed by researchers at the Medical College of Wisconsin (MCW).
