Monitoring, Audit and Quality Management Services.
In January 1995 the PHAROS Quality Management System was audited by an independent organisation (EQZert) and in consequence awarded the ISO9001 certification, which has been renewed annually ever since.
The know-how and experience we have gained in working with this very successful Quality Management System we now share with you in the form of special Quality Management Services.
The PHAROS Quality Management Services cover all aspects of Pharmaceutical Research and Development, going well beyond purely clinical Quality Assurance. All PHAROS GmbH Quality Managers and Quality Auditors have proper and extensive qualification and are all accredited by the European Organisation for Quality (EOQ).
Our CRO or Investigator Audits are focussed on your requirements and are planned, performed and reported in close co-ordination with you. Now you can detect weak spots before they adversely affect your research project, enabling you to manage and reinforce those weak spots, saving time and a lot of aggravation.
All PHAROS Audits are performed according to EN ISO10011, as suggested by e.g. the BPI and the BARQA, including an Audit Plan, Audit Checklists, Audit Reports (with suggestions on how to overcome deficiencies detected) and an Audit Certificate.
We prepare, perform and report our Monitoring Activities similar to our Audits, thus a PHAROS Monitoring is almost an Audit already - but at lower costs.
Our Quality Management Services:
For all types of Clinical Trials (Phases I to III, single- or multi-centre, in Europe and overseas)
• Clinical Trial Monitoring
• Study Audit Services
• Investigator and CRO Audit Services
• ISO9000 Services
• Quality Management Systems
• Site Monitoring Services.
• Site Initiation and Site Inspection Visits.
• Site Close Outs Visits.
Study Audits are independent of other monitoring or control functions. They can be performed during or after a Clinical Trial.
• GCP Audits for Clinical Trials Phases I to III.
• GLP Audits for bioanalytics, method development and validation.
• cGMP Audits for production, release, packaging, labelling, storage and accountability of clinical trial supplies.
Investigator and CRO Audit Services:
• Pre-Contract Site Audits.
• For Purpose Audits.
• System Audits.
• Procedure Audits.
• Investigator or CRO Evaluation Audit.
• Preparation of Sites for ISO9000 Certification.
• ISO9000 Staff Training.
• ISO9000 Compatibility Analysis of existing Quality Management Systems.
• Consultation on Quality Management Systems.
• Assessment of Quality Capability of existing Quality Systems.
• Assessment of Conformity with guidelines and requirements of existing Quality Systems.
• Set-Up of complete Quality Management Systems including SOPs.
• Implementation or Enforcement of Quality Management Systems
• Staff Training in Quality Awareness.
• All PHAROS GmbH Auditors and Monitors are qualified and accredited by the EOQ.
• All PHAROS GmbH Audits are performed according to EN ISO10011.
• You can use the PHAROS GmbH Audit Reports to improve your own Quality Management System.
• The PHAROS GmbH Monitoring and Audit Procedures are acceptable to all authorities and meet the requirements of all currently effective standards.
• You take advantage of our huge experience in superior Quality Management Systems and Procedures.