Ensuring patient safety in clinical trials requires team effort

The development of new drugs and treatments is a long and complex process where clinical trials play a crucial role. Ensuring and maintaining the rights, wellbeing and safety of patients during clinical trial conduct is the number one priority for all parties involved.

Pharmacovigilance is an essential part of the drug development process and patient safety is paramount at every stage of the product lifecycle. Patient safety is an ongoing process focusing on the detection of unidentified safety issues, identification of risk factors, quantifying risks and preventing patients from being unnecessarily adversely affected.

Pharmacovigilance requires submission of reports on adverse events during clinical trials to regulatory authorities within a specified timeframe, as well as notification of such events to investigators and ethics committees. Annual reports, a summary and analysis of all the serious adverse events, new safety findings, and evaluations of benefit and risk are also required.

When information about a patient safety case comes in, the process must remain rolling until resolution, and this is when seamless teamwork becomes priceless. The Crown CRO Pharmacovigilance team works closely with customers and regulatory bodies to meet and exceed all expectations and requirements in a highly regulated industry.

Our Pharmacovigilance team consists of professionals with different educational backgrounds ranging from Pharmacists to Medical Doctors with years of experience within the area of Pharmacovigilance. Our team works together to achieve a common goal: patient safety.

For us, patient safety is the ultimate goal and a team effort.

Crown CRO Pharmacovigilance – Anna-Leena Saarela, Heidi Kuusela, Linda Karlsson & Toni Mäki