We are able to provide support and advice in Preclinical Research projects through our collaborations with worldwide recognized Laboratories of Universities and other Research Institutions.
The ICI undertakes Phase I clinical studies, concerning the development of a new molecule, once its potential is assessed through extended preclinical studies and assays.
b.1 Study planning and preparation • Study protocol development, including statistical analysis plan. • Study feasibility. • Randomization scheme, if applicable. • Resourcing and budgeting. • Development of study documents (CRF, IC, diaries, questionnaires, etc). • Organization of trial supplies and laboratories (trial medication, lab. equipment, and logistics). • Site feasibility and selection. • EudraCT submission. • Preparation and submission of the trial file for approval by the relevant IRBs, Competent Authorities and Ethics Committees. • Preparation of the Investigator’s Study File (ISF) and Clinical Trial Master File (CTMF). • Organization and support of the Investigators’ meetings. • Investigators and/ or trial staff training to ICH-GCPs or examination techniques, as needed by the protocol. • Preparation of the Monitor’s Guide. • Qualified translations of the study documents. • Study registration in EU and/or FDA database.
b.2 Study execution • Study initiation. • Project Management and Trial Monitoring (with particular emphasis on issues relating to patient safety and rights, patient recruitment and retention, data accuracy and integrity, adherence to the protocol requirements, timelines and budget). • Preparation of the essential documents. • Medical and Quality reviews of the data. • Medical support and advice, if applicable. • Effective communication with the Sponsor, Investigational Sites and Authorities.
b.3 Study closure • Close out activities at the site (including trial files finalization and archiving). • Data entry, editing and statistical analysis. • Trial report preparation for submission to the respective Authorities. • Compilation and dissemination of study findings in both oral presentations and written publication formats.
This service includes comprehensive support during any stage of development and implementation of analytical epidemiological studies (case-control and cohort studies), as well as Post Authorization Safety Studies and Pharmacoeconomic Studies.
• Development of study design and methodology. • Data entry / data management. • Statistical analyses, including pooled meta-analyses.
The ICI offers full services regarding the preparation of the file to be submitted for Marketing Authorization of a generic drug in Greece or other EU countries. These services include protocol development, study approval by the pertinent Authorities, the clinical phase, the analytical phase, the statistical evaluation of the results and the final report. The operations are implemented in accordance with EU standards and the procedures of GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice).
• Trial specific site audits by independent and qualified personnel. • Support to the Investigation Sites for Internal audits or Authorities’ inspection readiness.
Institute for Clinical Investigation
|6, Poseidonos Av. Athens 17674 Greece|
|tel: 210 64 01 112|