JSH Surgical, Inc. is a company that provides services to the research community. With over 25 years of experience, we understand the trials and tribulation of building a solid research platform. For that reason we have developed a protocol to improve the strength, integrity and quality of research sponsored by companies who wish to demonstrate the superiority of their products. Within the pharmaceutical, biologic and medical device industry, there has been many criticisms of companies developing new products for the healthcare industry and soliciting researchers (physicians, surgeons, etc.) to obtain study results positive to the product. Whether this bias exists in the study or not, it is a perceived flaw in the research. JSH has developed a protocol which removes this bias from the company's research but still allows the company to find researchers to build a solid platform for their research.
What is the SEPP Protocol?
The Separate Entity Private Partnership (SEPP) Protocol was developed by JSH Surgical, Inc. as a way to remove the bias that currently exists within research of pharmaceuticals, biologics and medical device products when a company solicits outside researchers to investigate their products.
An example of using the SEPP Protocol is a company (ie Company X) which has a product they want investigated for FDA approval, publication and/or commercialization. In the current model Company X would find researchers to test their product. A researcher who decides to investigate the product might receive compensation (either stated or not) and have the possibility of being influenced by Company X to achieve positive results for Company X's product. Several critical reports in the major medical and surgical journals have emphasized this bias within current research practices. The SEPP Protocol is designed to remove this bias from Company X's research. JSH works as a neutral intermediary between Company X and the researchers. JSH begins by working with Company X to find qualified researchers from JSH's large database of researchers in the United States without disclosing contact information to Company X about the researchers. Once Company X has selected the appropriate researchers from JSH's database and the research project is outlined with proper milestones and data points, JSH begins contacting and setting up the investigation with the researchers without disclosing Company X's information. The researchers are independent of JSH Surgical and are not compensated by JSH Surgical in any way as to remove any possibility of influencing their research. All contact between the researchers and Company X goes through JSH to maintain a neutral position and remove the possibility of influencing the researcher. Company X can compensate researchers for work through JSH because researchers won't be sure if they are working for Company X or testing another companies material and thus must render an honest opinion and data of the product. All data points and milestones are adhered to by JSH staff so that Company X continues with the testing as was originally defined. At the end of the clinical investigation, JSH turns over all materials to Company X and once all data is ready, Company X is allowed to contact the researchers for follow up.