Our areas of expertise

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Through its consultancy, services and training schemes, Sunnikan supports pharmaceutical laboratories, biotech companies, research bodies, hospitals, contract research organisations and all clinical research stakeholders seeking to:

  • develop, roll out and maintain quality management systems
  • streamline their clinical research processes
  • ensure regulatory compliance
  • validate their IT systems
  • acquire support in preparing for inspections or ISO 9001 certification

Sunnikan ensure regulatory compliance and total pharmacovigilance process control by offering tailored solutions:

  • regulatory assistance and monitoring
  • pharmacovigilance activity audits
  • drawing up and updating standard operational procedures
  • validating pharmacovigilance IT systems

To help clients ensure compliance with regulations in force and the General Data Protection Regulation (GDPR), Sunnikan:

  • advises
  • carried out diagnoses and audits
  • provides training (particularly for Data Protection Officers known as DPOs)
  • implements compliant systems
  • carries out impact studies
  • develops the necessary documentary system (defining roles, procedures, impact analysis reports, etc.).

Sunnikan helps clients seeking to apply ISO 9001:2015 with a view to acquiring certification.

This is particularly relevant for clinical research and innovation departments, contract research organisations, clinical research service providers, etc.

Support in this area encompasses training, consultancy, drafting support, internal audits, etc. until certification is granted.

Validating IT systems is required by law for clinical research to be used in registration dossiers, and is necessary on both an ethical and scientific level for all other research.

Sunnikan supports clients (data management and statistics departments, clinical research service providers, IT publishers, etc.) in ensuring systems are approved.

This support includes training, consultancy, help with drawing up documentation, carrying risk assessment analysis, taking part in validation operations, etc.

Moving into clinical phases is always a complex task for biotech companies, as this process involves new regulations, new areas of responsibility, and new required skill-sets.

Support for these biotech companies might include:

  • Training (in regulations, clinical processes, clinical quality management, etc.)
  • Setting up a basic quality management system
  • Drawing up the standard operating procedures that are strictly necessary, but which will change as the clinical trials evolve.