Clinical Research Quality Management

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Sunnikan works with all types of clinical research

Clinical research lies at the heart of Sunnikan's expertise, and the company has been busily honing its skills in the area, developing inside-out knowledge of regulations and tasks (project management, administrative steps, monitoring, data management, statistical analysis) and quality management expertise.

Whether for medication, medical equipment, biotech products, nutrition or beyond, Sunnikan offers a wide range of comprehensive services adapted to the industry and research.

"RWHS" and "GMO" regulatory monitoring

Every month, Sunnikan publishes its regulatory monitoring updates in the areas of "Research With Human Subjects (RWHS)" and "Genetically-Modified Organisms (GMO)"

Inventories and recommendations

Sunnikan carries out inventories of quality management systems used by clinical research stakeholders (sponsors, contracted research companies, etc.) and advises them on achieving compliance in light of the regulations in force, or improving the efficiency of their systems.

Audits

Sunnikan works with clients around the world to conduct all the types of audit that may be required as part of clinical research: sponsors, contracted research companies, other service providers, investigation sites, data management, statistics, biology centralisation bodies, medical imaging, electronic case report forms, etc.

Sunnikan draws up audit programmes that are perfectly tailored to clients' needs and the research's end goals.

Clinical research procedures

Sunnikan supports clients through the processes needed to acquire IT system validation in compliance with Good Clinical Practices GAMP 5, 21 CFR Part 11:

  • Training sessions
  • Consultancy
  • Defining validation strategies
  • Drawing up validation procedures
  • Drawing up validation process documentation
  • Carrying out tests
  • Change control systems
  • Audits

IT system validation is an integral part of all the other services provided by Sunnikan.

Training

Sunnikan provides training sessions in line with the regulations in force, quality management techniques and operational processes such as:

  • French regulations (Loi Jardé, IT and Data Protection law, Good Clinical Practices law)
  • European regulations (Clinical Trial Regulation, Good Clinical Practices, General Data Protection Regulation, etc.)
  • Good Clinical Practices (ICH R2, France)
  • Clinical Quality Management Systems
  • Clinical Project Management
  • Validating IT systems
  • Clinical Research audits
  • Personal data protection in clinical research
  • Preparation for inspections...

Quality control

Sunnikan carries out various different types of quality control and assurance, such as:

  • Clinical trial report based on appendices
  • Clinical databases
  • Clinical trial documentation ("Trial Master File")

ISO 9001:2015 compliance process

Sunnikan boasts extensive experience in supporting and assisting clinical research departments in achieving compliance with ISO 9001 standard.

Preparing for inspections and follow-up

Sunnikan helps its clients prepare for inspections via: 

  • Training
  • Consultancy
  • Drawing up action plans
  • Providing operational support

Our training programmes

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As a training body, Sunnikan offers regulatory and quality training sessions

Our regulatory monitoring

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Sunnikan offers monitoring and support tools to help companies keep up to speed on their regulatory obligations