Rephine launches the innovative GCP Qualification Programme – FGK joins as first CRO

Press Release

Rephine is excited to announce the launch of the ground-breaking GCP Qualification Programme. The programme is a pioneering method to qualify Contract Research Organisations (CRO) and to evaluate their ability to perform clinical trials. The programme is an independent external qualification audit performed every two years. The audit verifies compliance with the GCP regulations, the company’s internal procedures and Rephine quality standards.

Dr. Rino Coladangelo, CEO at Rephine says: “Quality and Innovation are important elements of the Rephine culture hence the introduction of the GCP Qualification programme. The programme will continue the Rephine tradition of supporting the pharmaceutical industry in improving quality and efficiency within the industry”.

To join the Rephine GCP Qualification Programme, CROs must meet the Rephine quality criteria and pass the Rephine Qualification Audit to a satisfactory standard. FGK Clinical Research GmbH is the first CRO to join the GCP Qualification Programme. Several other CROs are currently in the process of joining the programme.

Martin Krauss, Managing Director of FGK: “We are very excited to be the first CRO in Rephine’s GCP Qualification Programme. It provides our existing and future clients the possibility to access Rephine’s audit report instead of the necessity to conduct a complex, costly and time-consuming audit themselves. The report consists of extensive information about all FGK’s operational procedures and competences, all of which is useful for them.”

The process

To join the Rephine GCP Qualification Programme, the CROs must meet the Rephine quality criteria and pass the Rephine Qualification Audit to a satisfactory standard. This is a very comprehensive and detailed two-step process carried out by an independent assessor/s.

The first phase of the programme is an evaluation through a detailed Rephine Questionnaire. The data obtained from this will be used to qualify the CRO and to produce an Audit Information Report (AIR). The information is reviewed by the auditor/s, and questions arising from this assessment can be discussed during the site visit.

The second phase of the programme is the site visit where an audit is performed by one or two consultants with a duration of 2-5 days on site, depending on the size of the company. The audit duration is longer than a typical audit and the Site Visit Report (SVR) enables in-depth evaluation of the audited CRO. Re-audit of the same company is carried out every two years.