Managing Quality in Epidemiology

Epidemiological studies are subject to the same validation requirements as clinical trials. And their regulatory framework is even more complex. In response to this Sunnikan can offer appropriate solutions: audits of epidemiological studies, regulatory intelligence and support, computerized systems validation.

Through its consultancy assignments, and the services and training it provides, Sunnikan lends vital support to sponsors of epidemiological studies and their services providers who are looking to:

  • maintain their quality, process and risk management systems,
  • control their processes,
  • guarantee their regulatory compliance,
  • audit their systems,
  • check (or audit) their information systems or changes to these systems (change control),
  • prepare for an inspection, etc.

Our services in Epidemiology

Consultancy

Regulatory support and intelligence

  • Monthly “Research in humans” regulatory intelligence bulletin
  • Pre-paid regulatory support services

Trouble-shooting

  • Company organization
  • Process efficiency
  • Regulatory compliance (gap analysis)

Audits

  • Audits of customer organization, regulatory compliance, information systems
  • Audits of contractors (qualification and follow-up audits)
  • Audits of the validation of information systems

Documentation system

  • Drafting of Standard Operating Procedures
  • Drafting of procedure appendices (Operating methods, document templates, forms, checklists, etc.)
  • Drafting of Job Descriptions, etc.

Computerized Systems Validation

  • Training
  • Approach to validation
  • Drafting validation procedures
  • Preparing validation documents
  • Conducting tests

Training

  • Training in applicable regulations
  • Training in Quality, Process and Risk Management Systems
  • Training in audits
  • Training in the validation of information systems
  • Training in Standard Operating Procedures