Socar Research SA

Principal activity SOCAR Research has over 25 years expertise and experience in the design, conduct, analysis and reporting of phase I to IV drug and device clinical studies and registries/observational studies in the cardiovascular, metabolic (lipid and glucose metabolism), central nervous system (including stroke), nephrology, ophthalmology, haematology (including iron deficient anaemia), oncology, cachexia and nutraceuticals. Services provided - All activities relating to the study design and set-up (including methodology input) - Development and writing of study documents (including study protocol, e-CRF, study-specific guidelines) - Identification and selection of experienced investigators - Regulatory: Preparation, submission and follow-up of study dossiers to the Competent Authorities and Ethics Committees - Complete electronic Data and study management activities using our proprietary software (e-SOCDAT? - www.esocdat.com ). The system enables, amongst others, EDC, web-based randomisation, pharmaco-vigilance, electronic management of endpoint adjudication, TMF and study/site management activities - Initiation, monitoring and close-out visits - Selection and implementation of study committees (such as Steering, End-point and Safety committee); interaction and organisation with the committees while the study is ongoing. - Complete statistical services (sample size, writing of the SAP, perform statistical analysis) - Writing of the clinical study report and main results manuscripts for publication in a (major) scientific journal.