Research Support Services
KGK Science is a full-service Contract Research Organization (CRO) offering human clinical trials to the health, functional food, ingredient and dietary supplement industries.
In addition to full clinical trial offerings, KGK Science provides a wide range of individual services to help support clients through the various stages of the research process. We offer several Clinical Research and Regulatory Services to assist companies in achieving their objectives. Our additional services include but are not limited to:
KGK will design customized clinical trial protocols optimized to detect significant effects of the study intervention in the population of interest while always abiding by ICH guidelines
KGK develops adaptable ICH abiding clinical trial protocols that facilitate modifications for use in multiple studies.
Case Report Form Development
KGK can construct customized forms designed to maintain GCP and data protection while providing the comprehensive capture of clinical trial data.
At KGK, we create source documents which are developed to collect all data specified by the protocol and designed to ensure the quality and integrity of the data being collected. Our source documents provide ‘real time’ data collection and ensure consistency among clinical coordinators. All data collected (source documents, adverse events, diaries, food records etc.) are reviewed by an internal monitor and all the data collected from subjects (paper diaries, food records etc.) are reviewed by the clinical coordinator with the subjects during each visit.
KGK will develop rigorous statistical analysis performed transparently to ICH standards for both initial data analyses and previously analyzed data.
Clinical Study Reports and Summaries
KGK can provide you with in depth organized reports following ICH guidelines which clearly present the details of the clinical trial design, the results of study and interpretation of the ramifications of the work. Our executive summaries provide a concise and accurate synopsis of the study. These documents are prepared in a format suitable for submission to any regulatory agencies.
Knowledge Transfer Materials Development
KGK frequently creates professional presentation materials for the dissemination of research at the expert and layperson level for meetings and conferences.
Our professional medical writers craft articles for medical and scientific journals tailored to your specifications. Articles may be commissioned for original research and/or literature reviews.