The use of multiple systems and a wide variety of information technology is gaining a great advance in clinical trials. This happens from the time the site is in the feasibility and identification process to the very end of the trial, where final reports are generated. Also, the recent update in the ICH GCP guidelines encourages risk management methodologies. Efficient quality-by-design and quality risk management methods can be done using several platforms and technology systems. This allow the sponsors and CROs to have a global vision of what is going on at different levels of the clinical trial. For example, there are several platforms regarding central laboratories, serious adverse events, patients’ quality of life questionnaires, drug dispensation, imaging, etc. All of this information, lets the sponsors and CROs what is happening in real time and have an overview of the sites’ performance.
At Althian, our staff is familiarized with all of these platforms and systems. We know the importance of having all of the data up to date, so we have strict metrics to upload information according to the requirements that sponsors and CROs give us.
Let us know if you would like more information regarding our experience in the information technology department and we will gladly help.