A comprehensive range of services

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Diagnosis

Prior to providing support services, the diagnosis stage (whether in the form of an inventory, a regulatory compliance audit, or an operational or organisational efficiency audit) results in an assessment report in which any potential non-compliant components are flagged and supported by recommendations for the action to be taken.

Consultancy

Recommendations, whether following on from the diagnosis stage or not, are always based on applicable regulations and recommendations as well as operational efficiency).

Training

Sunnikan's training sessions are based on the following three themes:

  • Legislation, regulations, standards, norms and recommendations
  • Quality, process and risk management procedures
  • Quality management system validation

Procedures

Implementing a quality management system results in drawing up a set of standard operational procedures.

Sunnikan drafts or updates standard operational procedures adapted to the context, area of activity and size of the department in question.

These procedures are designed to be compliant with all applicable framework documentation (regulations, ICH recommendations, directives, potentially ISO 9001 standard, etc.) and, where relevant, include all the necessary requirements with respect to personal data protection, IT system validation, etc.

Audit

Sunnikan works with clients around the world to carry out all types of audit in clinical research and vigilance: sponsors, marketing authorisation permit holders, contracted research companies, distributors, other service providers, investigation sites, data management, statistics, biology centralisation units, medical imaging, electronic case reports, etc.

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

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")