Quality Management in Clinical Research

Regardless of whether you are developing drugs, medical devices, or biotech or nutritional products, Sunnikan can offer you a broad range of specialist services: clinical trial audits and procedures, regulatory support and intelligence, validation of information systems..

Through its consultancy assignments, and the services and training it provides, Sunnikan provides vital support for pharmaceutical companies, biotech companies, research bodies, hospitals, CROs, and organizations involved in clinical research, looking to:

  • design, implement and maintain their own quality management system
  • control their clinical research processes
  • guarantee their regulatory compliance
  • validate their information systems
  • benefit from support when preparing for an inspection or a certification procedure

Our services in Clinical Research

Consultancy

Regulatory intelligence and support

Trouble-shooting

  • Company organization
  • Process efficiency
  • Regulatory compliance (gap analysis)

Audits

  • Audits of customer organization, regulatory compliance, processes
  • Audits of Investigating centers
  • Audits of contractors (qualification and follow-up audits)
  • Audits of the validation of information systems

Documentation system

  • Drafting of Standard Operating Procedures
  • Drafting of procedure appendices (document templates, forms, operating methods, etc.)
  • Drafting of Job Descriptions, etc.

Tools

  • Design of procedures intranets (operational intranets for instant availability of all the documents necessary and all the applicable regulations)
  • Creation of high-performance Trial Master Files (TMF)

Specific support

  • Preparation for inspections, and follow-up
  • ISO 9001 (certification, renewal)

Computerized Systems Validation

  • Data management systems, statistical analyses, IVRS/IWRS, CTMS, etc.

Training

  • Training in the regulations applicable to Clinical Research
  • Training in Standard Operating Procedures