Get Even More Visitors To Your Blog, Upgrade To A Business Listing >>

LIMS and Clinical Trial Transparency

A number of initiatives to promote the Transparency of Clinical trials have recently been launched. Both the FDA and EMA, the most important regulatory agencies that control drug approval in US and Europe, are committed to continuously extend their approach to transparency by publishing new policies and organizing consultations among stakeholders.

In this innovative and complex contest, there have been many stakeholders have been involved including: pharmaceutical companies, regulatory agencies, patients’ associations and clinical organizations. All of which have an active role in the process of Clinical Trial Transparency. But what does “clinical trial transparency” mean? It means that data from clinical trials will be completely or almost completely available for public consultation. This is an important achievement for scientists and investigators who perform clinical and epidemiological studies because with available and always updated data it will be possible to better design other trials and avoid repetitions or mistakes. Currently, data is manually loaded in specific platforms (i.e. in Europe, EudraCT) and then published. In the near future, these platforms will interface with other IT devices and data loading will be faster and easier.

The availability of LIM system that collects data during the research according to GCP (good clinical practices) and can talk with these regulatory platforms will help scientists to both perform study and pursue the transparency.



This post first appeared on 400 Bad Request, please read the originial post: here

Share the post

LIMS and Clinical Trial Transparency

×

Subscribe to 400 Bad Request

Get updates delivered right to your inbox!

Thank you for your subscription

×