Consulting & communication ►

Consulting & communication ▼

▪ Strategic and global drug developm(...)

▪ Communication

Pre-clinical studies ►

Pre-clinical studies ▼

▪ Overview

▪ Pilot and proof of concept studies

▪ Ocular efficacy studies

Clinical trials ►

Clinical trials ▼

▪ Overview

▪ Phase I

▪ Phase II - III

▪ Audits

▪ Patient and Investigator recruitme(...)

▪ Project management

▪ Medical writing

R&D support services ►

R&D support services ▼

▪ Animal model development

▪ Ocular histopathology

AUDIT OF EUROPEAN CLINICAL TRIAL SITES IN OPHTHALMOLOGY AS AN INDEPENDANT EXPERT.

The European Vision Institute. Clinical Trials. Sites of Excellence (EVI.CT.SE), a network of European Ophthalmological Clinical Research Sites with the highest standards of quality, has chosen Iris Pharma to be an independent expert. Iris Pharma optimizes the EVI.CT.SE network consolidation through consulting, sites audits and certification, following the European and International Directives for clinical trial research.

CLINICAL TRIAL AUDITS

According to ICH GCP 1.6, an audit is "a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s)".

Iris Pharma ensures that your clinical trials are performed to the highest standards, in compliance with the ICH-GCP requirements, European guidelines and applicable local regulatory laws.

Iris Pharma maintains its own Standard Operating Procedures (SOPs), which govern all critical activities in trial management, submission, monitoring and clinical writing. According to your requirements, we can also follow your own SOPs.

Our Quality Assurance department ensures SOP management, internal quality control (checking of the trial master file) and audit of Investigational Medicinal Product (IMP) suppliers and of investigational sites.

During an Investigational site audit our quality assurance department carry out checks to ensure:

• The Investigator´s file is up to date, accurate and complete (in respect of the Guideline for Good Clinical Practice (ICH Topic E6))
• Qualification of the investigator site
• Compliance with study procedures: subject information and informed consent forms, subject examination during the study, Serious Adverse Event (SAE) reporting and code-breaking when applicable
• Respect of Good Clinical Practice and of regulatory compliance with the national laws
• Suitable shipment, accountability and storage of the IMP on investigational site and presence of coding envelopes when applicable
• Case Report Forms (CRFs): 100% source data verification of a representative number of CRFs
• Quality control of the collaborating departments (e.g. laboratories)
• Archiving of documents during/after the study