Sca Profile
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South Cone Alliance is a multinational clinical research organization founded in 2011 by Clinical Trials Support in Chile and Pentha Research in Argentina. It provides full clinical research services across Latin America through local offices and affiliates in 8 countries. South Cone Alliance offers feasibility studies, regulatory support, site start up, project management, clinical trial management, pharmacovigilance, quality assurance, early phase facilities, and GCP training to pharmaceutical clients.
Sca Profile
- 2. OUR COMPANYMultinational Company that provides Services for Pharmaceutical Companies founded in 2011 by Clinical Trials Support (Chile) and Pentha Research(Argentina.)
- 3. The objective of this association is to provide full service in Clinical Research in Latin America. The local approach of our associates and their experience in regulatory issues give SOUTH CONE ALLIANCE the necessary strength to offer a full and multinational service to our clients.
- 4. South Cone Alliance administration has a Directorythatcontrolstheprocessesprovidedbyourclients, assuming a leadershipwithinourproyects.South ConeAlliance merges from the habilities and capablities of our members creating a strong skill identity.South ConeAlliance is a high value alternative in Latin America.
- 5. FOUNDERSGeneral CompaniesInformation:ClinicalTrials SupportCompany name : CLINICAL TRIALS SUPPORT LTDAHead office address Av Los Leones 2532, Providencia-Santiago CHILEPhone number +56 2 205 35 44Web sitewww.clinicaltrials.clCompany status LimitedCorporateContactinformation Carlos C叩ceres CEO -carlos.caceres@clinicaltrials.clGeneral CompaniesInformation:PenthaResearchCompanyName: PenthaResearchCompanyAddress: Paraguay 1570, Buenos Aires (C1061ABD), ArgentinaPhone/FAX: +54-11-58113881Web Site: www.pentharesearch.comCompany Status: LLCContactInformation: Gerardo M.Uviedo, MD-CEO -info@pentharesearch.com
- 6. COMPANY FEATUREFull-Service ClinicalOutsourcingSolutions in branchesbased in eightdifferentcountries.
- 8. FEASIBILITY STUDIESAnalysis on protocol in order to determineBest country, PI, site to conduct the trialEnrolmentProjectionsOverallcostsCheck up/comparison with historical database of like trial informationDevelop, distribute and assess site feasibility surveyProvidepatient/site/monthrecruitmentestimatesData base with more than 1000 Investigators in different specialities
- 9. REGULATORY AFFAIRSAdvice on Regulatory procedures in countries of operationEthicscommitteesubmissionsSiteRegulatory Files managementManagement of IRB documents and operationsLocal and Regional Regulatory Agency approvalsImport /ExportlicensesCustomconsultancy and management
- 10. STUDY START UPStudyDesign, Protocol/CRF developmentClinicalDevelopmentPlans (PM, Monitoring, Quality, Communication, etc)CertifiedTranslation of applicabledocumentsInvestigator/siteselection & patientrecruitmentstrategiesInvestigator Meeting Planning and executionLocal regulatorydocumentscollection & ManagementPreparation of country specific product labelsCustomconsultancy and management
- 11. LOCAL PROJECT MANAGEMENTThis service provides sponsors/clients with legal representation in Latin America for the conduction of a clinical trial enabling South Cone Alliance to:Execute contracts with PIs, sites & vendors on behalf of the clientAdministrate PI and vendor grantsRepresent sponsor at a local/ central EC卒s and IRB卒sRepresent sponsor for importation purposes
- 12. CLINICAL TRIAL MANAGEMENTActivities involving Ongoing trial ManagementRegulatory package preparation in accordance with country specific requirementsPatientscreening and randomizationSitemonitoringProject tracking via EDC systemManagement of Drug supply, laboratories and local couriersLocal and central safety managementCommunication with sites, sponsor and vendor /TLC, FtoF, internal project meetings)
- 13. REGIONAL PHARMACOVIGILANCEReceiving/Processing/Archiving adverse events in countries of operationMedicalmonitoringEthicscommittee/IRB & MOH submissionsEnsure compliance with local & International requirements
- 14. QUALITY ASURANCE SERVICESConduct of quality GCP auditsConduct of contract vendor/SUPPLIER AUDITSConduct internal (staff) and external (sites) GCP trainingDevelopment of Quality Plans, Quality Manuals, SOPs and SQPsOperational Headquarters successfully audited by sponsors.
- 15. EARLY PHASE DEVELOPMENT DIVISIONSItconsists of a exclusive suites located in ourbranchesspeciallyequipedtodevelopeearlyphasetrials (First in Human/IIa), combinedwith a highcomplexityfacilityiesmeetingalltherequirementsneededforsuccessfulexecution of thesestudies.
- 17. South ConeAlliance1220 N. MARKET STREET SUITE 806WILMINGTON -NEW CASTLEDELAWARE 198011 (302) 669-9100corporate@southconealliance.comOffice ARGENTINAParaguay 1570-C1061ABDBuenos Aires +54-11-4813.9410Office CHILEAv. Los Leones 2532 601Providencia Santiago+56-2-205.3544