Irish Medicines Board

The European Clinical Trial Directive requires that an application be made to the Irish Medicines Board [IMB] in order to obtain authorisation to conduct a clinical trial. Submission deadlines for applications occur monthly. Shandon Clinic has an excellent relationship with the IMB, having worked closely with this body for more than 15 years. We have the necessary expertise to ensure rapid submission and approval of clinical trial applications. Provided that the client supplies the limited pharmaceutical data required, permission to proceed with a clinical study is generally obtained within 30 - 45 days of submission.

Ethics Committee

Shandon Clinic submits all study protocols to the Research Ethics Committee of the Cork University Teaching Hospitals, an independent, university-based Institutional Review Board [IRB], which meets monthly. IRB submissions are processed in parallel with those to the IMB and so cause no additional delays. This Research Ethics Committee is accredited by the Irish Ministry of Health in compliance with the European Clinical Trial Directive.

Import and Release

Shandon Clinic holds a Licence to Manufacture issued by the IMB for the purposes of importation and release of Investigational Medicinal Product (IMP). This allows us to conduct studies for Sponsors based outside the EU, subject to a satisfactory inspection by a Qualified Person (Q.P.) who must take responsibility for the quality of the IMP to be used in the study.