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.
Recommendations, whether following on from the diagnosis stage or not, are always based on applicable regulations and recommendations as well as operational efficiency).
Sunnikan's training sessions are based on the following three themes:
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.
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.
Sunnikan carries out various different types of quality control and assurance, such as:
Real World Evidence studies, requiring access to PMSI data and on behalf of persons producing or marketing health products, may be carried out in France in accordance with the Benchmark Methodology MR-006.
In this context, such data processing must be in the public interest and must not have as purposes the promotion of health products or the exclusion of insurance contract guarantees or the modification of insurance premiums.
The Data Controller shall organize an independent external audit every 3 years following the signature date of the Compliance Commitment, in order to ensure compliance with the principles laid down by the law, in particular compliance with the prohibited purposes.
The audit covers the purposes pursued and the use made by the Data Controller of the results of the studies carried out.
Corresponding report must be sent to the Chairman of the SNDS Audit Committee.
Starting from this requirement, we have developed an audit methodology, based on applicable regulatory framework, related challenges and our experience of more than 25 years in health research.
Since 2021, Sunnikan has performed about ten MR-006 audits.