Research conducted by biopharmaceutical companies is moving the needle on scientific discovery and helping patients to live healthier lives. But the clinical trial process is burdened by complexity and administrative costs, so to reduce risk of errors and to ensure faster time to market, more flexible monitoring approaches can be implemented.

On complexity…

Clinical trials are up against a number of modern challenges that make the development of a drug and its delivery to patients more complex than ever. Chief among them:

Quality data is critical to the success of a clinical trial. Poor data quality can result from a number of behaviors:

• Lack of understanding of the protocol (unintentional) or intentional non-compliance
• Carelessness on the part of investigators or sponsors
• Intentional misconduct – frequently motivated by personal gain

These behaviors can produce errors that may impact patient welfare or interpretation of trial results, which can then jeopardize the understanding of the risk-benefit profile, as well as the development of a drug that is eventually marketed to the public.

In other words, reliable trial results mandate quality data.

1. US FDA