SOCAR's approach to quality

SOCAR recognises that maintaining accuracy and quality is an essential continual, dynamic process in the lifecycle of a clinical research study. SOCAR's Quality Management System ensures reliability and accuracy of information in all steps of the clinical research projects carried out by us.

SOCAR has implemented a robust Quality Management System thus giving our clients the confidence and assurance that the ICH GCP code of conduct for clinical research is respected – namely - the data and reported results for research projects performed by us are credible and accurate and that the rights, integrity and confidentiality of the patients included in the research project are protected.

SOCAR's Quality Management System may be summarised as follows:

Research study phases SOCAR's approach to Quality

From A
STUDY DESIGN
&
SETUP
  • Setup the research study in accordance to ICH GCP and SOCAR's availability of detailed Standard Operating Procedures (SOPs)
  • Sign off and approval of all study-related documents
  • Development and implementation of detailed study-specific guidelines
  • Development of a study-specific Manual of Procedures (MOP) which contains information concerning the conduct and operations for each study
  • Development and validation of the study computerised systems in accordance to GxP and other applicable requirements
  • Development of study-related instructions and guidance for participating sites
  • Change control management procedures
  • Focused internal training (e.g. SOPs, study-specific guidelines, study protocol, regulatory requirements updates) documented in individual training logs
  • Development of site-specific training material (e.g. audio-visual, videos, electronic)
  • Documented training for site personnel involved in the clinical research project
CONDUCT
&
CLOSE-OUT
  • Frequent on-site monitoring visits with source data verification and contact with the participating sites; co-monitoring where appropriate
  • Ongoing and documented training of the project team and site personnel
  • Concurrent database management with medical and non-medical related data cleaning performed simultaneously; extensive and validated queries; locking of clean data on an ongoing basis
  • Generation of data queries to resolve incoherent or missing data
  • Continuous identification of variability and trends, including outlier data
  • Regular study-related meetings (internal and with the sponsor)
  • Continuous availability of up-to-date status listings and study metrics information
  • Continuous QC checking of all data
  • Audits (independent) – random or for cause of computerised systems, study database, monitoring systems, sites, etc.
    ANALYSIS
&
REPORTING
     
  • Writing of a detailed statistical analysis report which is approved and finalised prior to database lock
  • Annotated (e)CRF
  • Independent validation of SAS programs
  • Validation of SAS output – tables, figures and listings
  • Independent analysis
  • Proof reading and sign off of study report, manuscripts for publication in major peer review journals
  • Audit of study report
to Z

Clockwork quality
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