Biomedical Research - What are the solutions ?

SUNNIKAN Consulting suggests :

the human resources necessary to give answers to all of those needs

Keen know-how, given in a punctual way, on demand or over a long period of time

adapted solutions to every context, notably:

• Consulting:
  • Proven expertise in the field of Quality, Process, and Risk management in biomedical research
  • The description, modeling, and optimization of processes and interfaces (Pharmacovigilance, Biometry, Headquarters, etc.)
• A documentation system:
  • The design and writing of procedures, as well as standard documents, job descriptions (Project Manager, CRA, etc.), form letters, work instructions, and, if necessary, an update on recent European and French regulations
  • Participation in work groups and the formalization of the described processes
• Tools:
  • An operational Intranet, either exclusive to the Clinical Research Department or expanded to other departments, which allows an instantaneous release to all colleagues (on- or off-site), not only the documents necessary for their activities, but also all applicable regulations related to their activities
  • A computerized Standardized Study File: allowing, within a few clicks, the set-up of a sponsor study file comprised of headers and necessary checklists
• Training:
  • Training sessions on Quality Management applied to biomedical research, and adapted to make a link between Quality Assurance, Methods, and Biomedical Research
  • Training sessions specifically tailored to the department's needs
• Audits :
  • Organizational and/or regulatory global, or per process audits: Investigational Medicinal Products, Biometry, Documentation, etc
  • Subcontractor audits
  • Investigator Site audits (routine, ‘for cause,’ or preliminary to a regulatory inspection)
  • Action plans comprising improvement suggestions and support for its implementation
• Regulatory intelligence and assistance

• Computerized Systems Validation applied in clinical research

• Support :
  • In the preparation and the follow-up of the regulatory authorities’ inspections, in collaboration with the concerned operationals
  • Support during the ISO 9000 certification process: our team, at the initiative of the first worldwide certification ISO 9001 in clinical research, accompanies you throughout the certification and renewal process, ensuring an up-to-date version 2000 of the ISO 9000 norms