Integrated BioScience Solutions provides a full range of Clinical Development Services, covering study preparation, site training and initiation, routine investigator site monitoring, and close-out activities. We work in an integrated fashion with our clients to ensure investigative sites are in compliance with GCP/ICH FDA regulatory requirements and that subject data are collected consistently and accurately, ensuring poolability of data across investigative sites. SERVICES PROVIDED Study Preparation · Protocol Development and Medical Writing · Statistical support and power analysis · Case Report Form Development · Informed consent development · IRB Selection and Client Submissions · Investigator regulatory document review and collection · Tracking site IRB submissions · Investigator recruitment, site qualification, and selection · Selection and management of ancillary service providers including clinical · laboratories and supply providers. Clinical Trial Management · Investigator meetings · Initiation visits · Routine data monitoring and site visits · Study progress reporting per client specifications Data Management and Statistics · IGBS works with affiliated statisticians with experience in FDA statistical · submissions · IGBS provides and develops

· Data entry guidelines · Database specifications · Data verification and logic checks · Query generation and resolution with Investigative Sites · Data entry and reporting using SAS via electronic data entry at the · Investigative site or, double data entry for paper based systems.