Group Central Office
The Group Central Office (GCO) based in Dublin, has a role in project management, pharmacovigilance, on-site monitoring, group meetings and international collaborations. Since its inception, GCO has managed and monitored the accrual of more than 7500 patients to more than 260 high quality studies. There is a considerable level of experience and knowledge amongst current GCO staff with more than 200 combined years of experience in the management and monitoring of clinical trials, much of it gained in pharmaceutical industry registration standard studies. In recent years, GCO has participated in a number of investigational new drug level studies and has succeeded in producing high quality data matching the standards of international collaborators.
GCO Staff
GCO currently has a staff of 28, comprising Chief Executive Officer, Project Managers, Clinical Research Associates, Trainee Clinical Research Associates, Quality and Training Manager, Clinical Trial Administrators, Data Management Team Leader, Data Entry Associate, Statistician, Pharmacovigilance Manager, Pharmacovigilance Associate, Administrative Assistants, Financial Controller (PT) and Trainee Accountant.
There is a team based approach to on-going projects which means that the project management group also contributes to the on-site data monitoring function. The GCO has a number of projects in the advanced stages of development and anticipates adding to its resource in the coming months.
GCO Functions
GCO has responsibility for all the operational aspects of ICORG activities, facilitating the 16 hospital sites throughout the country in all aspects of the ICORG clinical research programme. This includes many of the elements associated with the design, development and conduct of clinical studies. GCO also manages new relationship development and is thereby responsible for sourcing new studies. A continuous dialogue takes place between GCO and the Team Leaders based at each site, such that the Team Leaders function as a critical link in the greater ICORG network.
GCO also co-ordinates the activities of the Disease Specific Sub-Groups (DSSG’s) through which the Scientific Development of ICORG is formulated. GCO provides local expertise in regulatory and ethics processes in Ireland, the UK and Europe. It is Eudravigilance accredited by the European Agency for the Evaluation of Medicinal Products (EMEA), allowing direct access by GCO employees to the European safety database.
GCO has experience in drug distribution, accountability and labelling, which has facilitated the movement of drugs from the US for NSABP C-08 and other activities.
Finally, GCO manages and coordinates many elements of the clinical trial process.
