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Service Centre

Quality

Eurotrials, Consultores Científicos, S.A.

Service Centre category(ies)

Clinical Research / Clinical Trials
ICT & Electronics / Bioinformatics / Biomodelling / Biostatistics

Description of the Service Centre

The Quality department is an independent department made up of a multidisciplinary group of auditors. They have vast experience in quality control and quality assurance, namely GCP audits. In addition to outsourcing, they ensure that the work of the other Eurotrials departments complies with ISO 9001:2008, the legislation in different countries, the rules of good clinical practice (ICH-GCP and GCP Directive) and any other applicable regulations.

Service Centre web address

http://www.eurotrials.com/index.php?m=21&idioma=2

Contact person's name

Susana Paulo

Contact person's e-mail

susana.paulo@eurotrials.com

Contact person's telephone

(+351) 21 382 54 40

Services

Service

Quality Consultancy

Available for external use?

Yes

Comments

• Elaboration and revision of SOPs – industry and research centres and planning, organisation and training in new SOPs • Preparation of co-monitoring visits, audits and inspections of Clinical Trials • Capacity building of research centres • Discussio

Service

Quality Control

Available for external use?

Yes

Comments

• Update and review of study records (“in-house” or research centres) • Accompaniment on monitoring visits • GCP training for all those involved in clinical trials

Service

Quality Assurance

Available for external use?

Yes

Comments

• GCP audits Systems: Industry, research centres or others Clinical trials: documentation, research centres, monitoring, pharmacovigilance, TMF and archive. • Preparation of Inspections (FDA, EMEA and INFARMED) Coordination of inspection preparatory

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