Clinical trials module
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 importantly, 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 organisations, brokers, underwriters) in real-time.
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 utilisation 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
- standardise processes enabling risk management to control the distribution of information without need to be directly involved in each transaction
Features
- configured to align with the needs of the company; including fields name, type and purpose of the study, study ID number, start and end dates, phase, risk level and address
- standardised, easy-to-use frameworks that provide mechanisms for continuous data flow – including data sets, programmes, reports, documents and images
- automatic report distribution to stakeholders to ensure proper communication of all activities
- time stamping capability allows the risk manager to monitor and determine current stage of the trial and progression in status
- browser-based system allowing all authorised users – regardless of their technical proficiency – to access data via an intuitive interface to perform analysis and run reports
- graphical dashboards with alerts to visually identify when certain criteria are met
- multi-currency and multi-language capabilities for a true global solution for multinational organisations
- ability to integrate real-time with different systems for faster data exchange, query resolution and data reconciliation
- accessibility to technical information about local regulations governing clinical trials and related insurance requirements