Vendor Oversight (CRO.Cloud) Martin
Why CRO Oversight matters?
One can delegate a task, but one cannot delegate responsibility. For a pharmaceutical organization, getting approval for a medication from regulatory agencies remains the ultimate target. In order to have full control over the flow of a clinical trial, we suggest passive, objective monitoring of a trial when it is conducted by a Contract Research Organization (CRO).
A specialized software system, EarlyBird, performs an everyday analysis of your clinical data by the CRO. It is like a “virus scanner” that runs on clinical data and detects data anomalies and early risk indicators.
How much effort would it be for me?
Nearly none. You need not be a medical statistician or have specialized knowledge about sophisticated software – all complex tasks involved in data analysis happen in the background, and you just get an easy to understand report that enables you to make decisions and take actions in real time.
How does it work?
The system uses reference data from previous clinical trials and identifies statistical anomalies and wrong dynamics within your clinical trial. Based on all incoming data, it calculates and checks patient specific thresholds and the boundaries and dynamics of parameters. All data defects and other relevant events are then evaluated for their impact on your study.
What is under control?
A dashboard presents you the specific risks that you have to control. The system EarlyBird incorporates heuristics that identify unknown risks as well. By using the system, you can have oversight and minimize the impact of risks arising from sites’ sloppiness, fraud, poor patient recruitment, protocol non-compliance, technical defects, the misconduct of devices, etc.
How about processes?
Cyntegrity helps you to implement a process of CRO Oversight. Involving you in decision making and the definition of risks, we develop actionable risk oversight plans. By using the best practices of change management, we help you to switch to a more effective procedure, following the upcoming GCP addendum E6 (R2) recommendations.
The solution focuses on all anomalies in the early stages of clinical trials and increases the quality of data. High quality clinical data reduces monitoring costs and secures FDA/EMA approval.