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CYNCRON

Clinical Research, Data Management, Biostatistics, Pharmacovigilance and DMC/DSMB Services

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Quality Management

CYNCRON

Quality Management (QM) is an independent unit at Cyncron. From early study synopsis to final reporting QM assures that all quality aspects are adhered to at Cyncron.

They secure full compliance with regulatory requirements, Cyncron and Sponsor Standard Operating Procedures (SOPs) and ICH Guidelines. In addition, Cyncron QM offers a variety of services to clients:

GCP audits:

  • Sponsor company – e.g. system audits, trial audits of sponsor suppliers and audit of IT systems
  • Investigational sites

QA consultancy and support sponsor staff in:

  • Quality system development
  • SOP design, development and implementation

ICH/GCP training:

  • Sponsor company – Staff and CRAs
  • Investigators and research nurses
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