GeoSera

Our value proposition: • We can serve as a one-man clinical team to keep costs low but provide clinical expertise to companies looking to stretch their staffing dollars. • We offer companies fractional employees, functional service providers (FSPs), or project-based/hourly clinical staff, which is attractive to small companies that do not want to have permanent employees on their balance sheet. • Our flexible model gives companies greater control over key tasks and responsibilities, reducing the need to outsource all activities to a CRO and permanent employees while also keeping costs low because of the nature of our fractional employees. • We have a range of experienced clinical personnel, from Associates to Executive Directors that can work as 0.25 - 1.0 FTE, as needed and can scale up or down based on corporate needs. High-level list of our services, which can be provided à la carte: • Clinical leadership over internal and external operations that is responsible for all deliverables relating to drug development • Vendor and CRO management by acting as the point persons for all aspects of clinical trial execution. • CRA, site management, and responsible for site deliverables • Medical writing, including IB, CSR, IND, ICF, protocol, and communication with regulatory authorities • Medical monitoring and responsible for medical and safety data review • GxP auditing of sites, vendors, and CROs