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Case Studies
Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Gastro Esophageal Reflux Disease, or GERD, is recognized as a significant public health concern. Prolonged exposure to acidic contents can lead to esophageal complications, including a 40-fold increase in the risk of esophageal cancer. While a number of different treatment options exist, ranging from drug therapy to surgery (open surgery, laparoscopic and endoscopic procedures), adverse events and low treatment efficacy continue to raise the need for newly innovative interventions.
A medical device company developed an innovative, minimally invasive procedure to relieve symptoms of GERD. The open-label study included six sites in four countries. Instead of recruiting, training and engaging an internal group of clinical monitors and study management team, the client leveraged Boston MedTech CRO’s experience to monitor the multi-national study.
Boston MedTech CRO provided all clinical monitoring in the US sites, as well as convening and coordinating the Data Safety Monitoring Board. In addition, Boston MedTech CRO assumed overall responsibility for all data management elements of the study, including review of all CRFs, design and maintenance of the study database, data entry and verification services of data collected in all participating sites in the four countries, generating and resolving all queries, and conducting the final statistical analysis and developing the final report in support of filing an application for FDA approval for the technology and the specified indication.
An on-site audit of Boston MedTech CRO, reviewing study results, data management procedures and overall study management has been conducted by FDA, leading to a ‘perfect’ report (no negative findings found).