SERVICES
SALUBRIS-cro is specialized in the
following areas:
Trial management in compliance with local regulations,
ICH and GCP:
- Literature review
- Preparation
of protocols, case report forms and other locally required documents
- Translation
and review of study documents
- Identification
of qualified investigators and preparation of investigation centers
capable of conducting trials to the required standards and with
access to appropriate patient pools
- Obtaining all
necessary regulatory and ethics approvals
- Trial monitoring
by trained monitors including initiation, interim and closure
visits and quality control
- Quality assurance
audits (back)
Data management and statistics
- Database design
and development
- Data coding
and double entry
- Statistical
plan
- Statistical
analyses
- Statistical
report (back)
Medical writing
- Integrated statistical-clinical
reports
- Manuscripts
- Scientific presentations
(abstracts, posters, etc)
(back)
Post Marketing surveillance
- Adverse event
reporting
- Pharmacovigilance
studies
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