AG Mednet Addresses Cardiovascular Trial Needs for Data Collection and Quality
AG Mednet announced the availability of new capabilities to enable sponsors, CROs and core laboratories to take delivery of electronic trial data into configurable file structures residing either locally or in any of their network shares. By allowing meta-data to be assigned to non-DICOM modalities , this provides for better quality data and less delays for modalities that do not yet conform to the DICOM standard. These include Holter data, spectral domain OCT and others.
For sites participating in AG Mednet-based trials, the imaging submissions remain consistent across the DICOM and non-DICOM data sets. For sponsors, CROs and core labs, non-DICOM modalities are delivered to a file system-based infrastructure, while DICOM modalities are delivered either to a standard DICOM environment, or the same file system-based infrastructure.
You can read the full release here.
Comply with ICH E6 (R2)
The ICH E6 (R2) GCP Guideline became final in November 2016. As noted in the Guideline, since the original ICH E6 (R1) was released, clinical trials were performed in a largely paper-based process. E6 (R2) was developed to address the increased scale, complexity, and cost of clinical trials, and to include the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches and, in fact, encourages the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
The articles can help ensure your GCP is up to par in the areas included in the ICH E6 (R2).
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