In a context of increasingly high rates of failed CNS studies,
research findings clearly indicate that quality risk signals go undetected.
Other companies focus on managing data integrity and error by taking a scatter gun approach. Cronos has implemented an integrated approach using the underlying principles of risk-based data monitoring while concentrating on the likelihood of data quality issues and their significance to the outcome of the trial.
When the risk of data integrity is identified and evaluated, it then drives the type of response we apply. For example, the high likelihood/low significance type of error may justify a simple action to correct behavior while a low likelihood but highly significant problem may require a more robust response. In extreme cases, the appropriate response may be to limit the sites recruitment allocation or to perfrom an on-site monitoring visit.
Our automated risk-based surveillance of item level transactions coupled with advanced analytics and reporting offers the best protection against inadvertent mistakes and organized non-compliance. Our data monitoring is not limited to a particular population, protocol, or compound. Whether you are conducting a study in pain, schizophrenia, depression, bipolar disorder, MDD, anxiety, or cognition, Cronos risk-based data monitoring is an integral part of any study execution.
Cronos’ clients are reassured knowing that emerging risk signals in outcome measures are identified early, addressed in a consistent way, and corrected in a timely manner. Clients trust our system to:
“Cronos' system allowed us to identifiy an emerging GCP risk signal - Cronos monitoring has become an important part of our study execution.”
Global Trial Manager