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ponsors of clinical trials are responsible for the monitoring of clinical investigations and for assuring the quality of data submitted to the regulatory authorities. Under the International Conference on Harmonisation (ICH) guidelines, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems to ensure that trials are conducted, and data are generated, documented, and reported in compliance with the protocol, GCP, and applicable regulatory requirements.

Who’s monitoring the monitors?

MedTrials can. Increased regulatory rigor and concern over inadequate monitoring sited in recent FDA warning letters has triggered the need for increased oversight. Most sponsors conduct audits of high enrolling sites to ensure accuracy and to assure that the study data will be able to support the product approval in the event of inspection. Sponsors are not the only organizations who need to conduct audits. CROs, IRBs, SMOs, and investigators also conduct routine audits to assure the integrity of the research and the protection of human research subjects; especially if there are numerous sites, high turnover, or contract monitors. In an industry where compliance is mandatory, audits are recommended when organizations are faced with the need to investigate performance or potential misconduct. Don't chance it when you can utilize an experienced and reputable group like MedTrials.

• Research process
• Regulatory documentation
• Data integrity
• Product accountability