SOCAR's e-Clinical solution

Our involvement in clinical research

    Through a competent and highly trained team of professionals with extensive experience in the concept, set-up, conduct, analysis and reporting of clinical research projects, SOCAR Research offers services which are of high quality and scientifically-robust in a flexible, time-efficient and cost-effective manner.

The services described below are provided by SOCAR either individually or as a package.

Clinical Research phases SOCAR's services

From A
RESEARCH
CONCEPT
  • Access to a network of academic and opinion leaders
  • Identification of expert committees
  • Organisation of round-table discussions
  • Extensive literature research
  • Planning and preparation of regulatory meetings
  • Scientific and clinical research expertise
  • Support for clinical program development
  • Study design and methodology
SETUP
PHASE
  • Document preparation (e.g. protocol, e-CRF, patient information sheet and informed consent form, patient diaries, instruction sheets)
  • Sample size calculation, statistical considerations
  • Web-based randomisation
  • Competent Authority and Ethics Committee dossier preparation, submission and follow-up
  • Establish study committees and their membership
  • Site selection, initiation visits, site contracts
  • e-TMF setup
  • Database preparation and implementation
  • Study treatment supply management
  • Training of site personnel and project teams
CLINICAL
&
CLOSE-OUT
PHASES
  • Subject recruitment (healthy volunteers/patients)
  • Complete project management (including Committee management)
  • Complete data management, data coding
  • Site management, investigator payments
  • On-site monitoring, close-out visits
  • Pharmacovigilance activities
  • Regulatory follow-up
  • Management of endpoint classification
  • Preparation of DSMB reports/meetings
  • Statistical Analysis Plan writing
    ANALYSIS
&
REPORTING
     
  • SAS programming
  • Statistical (interim) analysis
  • Preparation of manuscripts for peer-review journals
  • Writing of the clinical study report
  • Meta-analyses
to Z

SOCAR's services
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