Lampgen Clinical Research

need for qualified personnel to provide study oversight and experienced clinical sites was growing exponentially. While the volume of clinical trials were trending up during this period, according to the FDA Office of Scientific Investigations, the overall quality of several clinical investigations was not. Between 2009 and 2013, a total of 83 warning letters were issued by the FDA to clinical investigators, institution review boards (IRBs), biopharmaceutical companies, and CROs. Violations included findings such as improper supervision by clinical investigator, failure to obtain informed consent, and failure to properly monitor a clinical investigation. Issues such as these endanger the lives of clinical trials volunteers. Lampgen was founded to achieve a new standard in clinical development and aid companies in quality research. Lampgen’s model was developed from researching the best practices in clinical development at the academic, CRO, and Sponsor level. It was determined that providing companies with rapid access to expert clinical research professionals to provide oversight at sites was one key to quality clinical develoment. Additionally, it was ascertained that developing existing medical practices into viable research site with internal quality assurance was a proactive method of enhancing the integrity of a given trial. Combining these two elements, Lampgen came into existence with the goal of illuminating new pathways to clinical development.