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
- 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
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