Clinical trials tracking

Clinical trials or clinical research is the process of testing the safety and efficacy of new drugs. This process is an expensive undertaking for pharmaceutical companies representing up to 45% of the cost to bring a drug to market. The stakes are high not only because of the massive costs but, more important; being the first to market a new drug results in huge benefits to the company. Since patents are issued before a drug goes through a trial, the faster the pharmaceutical company can bring the product to market, the longer it enjoys the sole distribution before competing against generic alternatives.

A consolidated overview of the company’s clinical trials is a resource intensive task. For example, what is the purpose and duration of the study? How many patients are participating? What coverage do the authorities in the respective country accept? Has the proper insurance documentation been provided to regulators?

As the primary method of maintaining and sharing insurance certificates, RiskConsole provides a clear understanding of the diverse range of data required by the host country while facilitating the coordination of all communication and activities among the various stakeholders (risk manager, researchers, project managers, clinical directors, clinical research organizations, brokers, underwriters) in real-time.

 Key benefits

• Reduce risk of lost records, incomplete items and overdue tasks by tracking certificates of insurance and T85 protocol documents electronically in a single database.
• Increase resource utilization and collaboration by automating workflow processes and provide secure access to related information across multiple protocols, sites, studies, teams and trials.
• Increase efficiency by reducing the time your clinical managers and risk management personnel need to allocate to secure clinical trial certificates and policies in compliance with local regulatory authorities.
• Reduce the number of days between the initial request and date actually receiving the certificate of insurance evidencing local clinical trial coverage.
• Enhance data management and analysis giving an immediate understanding of trials being undertaken and the extent of the exposure.
• Standardize processes enabling risk management to control the distribution of information without need to be directly involved in each transaction.