Whether for medication, medical equipment, biotech products, nutrition or beyond, Sunnikan offers a wide range of comprehensive services adapted to the industry and research.
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.
Regulatory monitoring newsletters
Sunnikan issues monthly regulatory monitoring newletters:
Gap Analysis
Sunnikan carries out assessments of quality management systems used by clinical research stakeholders (Sponsors, contract research organisations, 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, contract research organisations, other service providers, investigation sites, data management, statistics, central laboratories, medical imaging, electronic case report forms, mock-inspections, etc.
Sunnikan draws up audit programmes that are perfectly tailored to clients' needs and the research's end goals.
Clinical Research Procedures
Sunnikan writes or updates sets of Standard Operating Procedures (SOPs) adapted to the context, activity and size of the company.
These procedures comply with all applicable standards (regulations, ICH recommendations, guidelines, ISO 9001 standard, etc.) and, where relevant, include requirements regarding personal data protection, computerised systems validation, etc.…
Mock inspections, preparation and inspection follow-up
Sunnikan helps its clients prepare for inspections via:
Computerised Systems Validation
Sunnikan supports clients through the processes needed to acquire IT system validation in compliance with Good Clinical Practices GAMP 5, 21 CFR Part 11:
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:
ISO 9001:2015 compliance process
Sunnikan has an extensive experience in supporting and assisting clinical research departments in achieving compliance with ISO 9001 standard.
Quality control
Sunnikan carries out various different types of quality control and assurance, such as:
Our training programmes
As a training body, Sunnikan offers regulatory and quality training sessions
Our regulatory monitoring
Sunnikan offers monitoring and support tools to help companies keep up to speed on their regulatory obligations