NUIG-EOI1001-15 - Expressions of Interest - Audit of Procedures and Practices in Regulated Clinical Research

The purpose of this call for Expression of Interest is to ascertain the marketplace for Audit of Procedures and Practices in Regulated Clinical Research. Activity 1: Review and assessment of risk mitigation plan for clinical trials conducted in HRB-Clinical Research Facility (NUIG and GUH), where NUIG is the legal Sponsor of such trials. The implementation of a Risk-based Audit programme for Sponsored Trials is a requirement for NUI Galway. We require the short-term services of an individual/team acutely proficient in the area of clinical trial European and national legislation and associated ICH-GCP guidelines to audit existing activities and provide a knowledge base to confirm/enable adherence to legislation and all applicable regulations, thereby protecting all ongoing and future clinical research activities from the Sponsor point of view. In light of the roll out of the new EU legislation for clinical trials in 2016, it is crucial that the mitigation strategies identified and implemented are future-proofed. Activity 2: Assessment of the Data Management infrastructure within the HRB-CRFG and implementation of cost-effective and efficient processes in line with current Irish, European and FDA legislation regarding data compliance for clinical data systems and data security and data protection legislation and guidelines. The successful vendor will undertake an immediate and extensive review of a number of critical areas in clinical research in the HRB-CRFG and will provide recommendations to the Governance teams of NUIG and HSE to ensure compliance as outlined above. The successful vendor will have an inherent understanding of the Irish and European clinical research landscape and will be in a position to undertake this audit immediately on award of contract. Completed Expression of Interest documents must be emailed to tenders@nuigalway.ie by 10am, Thursday, 26th November 2015.

Services

26/11/2015 10:00:00

73110000-6  Research services