Case Studies

Filtered by Client: Service Organizations

Electrical Impedance Myography Trial Situation: A virtual operating company in partnership with a patient association focused on a rare pediatric disease identified a promising technology for use in measuring muscle health. The organization wanted to run a clinical trial to compare the technology to standard ... Needed: An Audit-Ready Quality System Situation: An academic research organization (ARO) with rapidly increasing service offerings, including support of IND clinical trials, was in need of a quality system that would withstand Sponsor and regulatory authority scrutiny. Solutions: In less than twelve weeks, ... Needed: An Expanded Audit-Ready Quality System Situation: An academic research organization (ARO) with rapidly increasing service offerings needed to expand their quality system, ensuring it would withstand sponsor and regulatory authority scrutiny. Halloran had previously delivered 11 Standard Operating Procedures (SOPs) ... Quality System Development to Support Expanded Services Situation: A service provider whose primary focus was the business and financial management of clinical trials for sponsors decided to expand their services to include Site Activation Services (SAS).  The SAS group's function was to provide regulatory document management ...