Clinical trial contract research organization (cro) turkey


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Clinical trial contract research organization (cro) turkey

  1. 1. © 2011 TRIO GRUP
  2. 2. TRIO GRUP CLINICAL RESEARCH (CRO)Established in 2011TRIO GRUP headquarter is in Ankara, TURKEYApproved by Turkish regulatory authority Ministry of Health according to the regulations lastly released © 2011 TRIO GRUP
  3. 3. TRIO GRUP CLINICAL RESEARCHProvides clinical research services for pharmaceutical product development from phase II through phase IV and post marketing survelliance. TRIO GRUP is your way to high quality design, conduct and analysis of clinical trials.Our staff, zealously live and breathe their projects, providing meticulous attention to the details. They ensure that executions are crisp, timely, and accurate.You receive truly personal service - and our senior management gives you their attention. © 2011 TRIO GRUP
  4. 4. PROJECTS THERAPEUTIC AREASOncologyCardiologyRheumatologyPediatryNeonatalogy © 2011 TRIO GRUP
  5. 5. THERAPEUTIC AREAS OF EXPERTISEOncologyCardiologyRheumatologyPsychiatry/PsychologyEndocrinologyNephrologyOphthalmologyNeurology © 2011 TRIO GRUP
  6. 6. CRO PRODUCTS AND SERVICESTRIO GRUP commits to provide sponsor with highly qualified regional based Clinical Research Associates which substantially reduces the overall cost of the project and ensures its timely completion. We have experienced staff in most geographical regions. This sets TRIO GRUP apart from other CRO-s that might not have such extended capabilities. © 2011 TRIO GRUP
  7. 7. CRO PRODUCTS AND SERVICESClinical Trials and PMS Studies ; Protocol Design and Adaptation CRF / e-CRF Design PIS / ICF ve Design Site Selection Ethic committee / MoH Submission File Project Management Monitoring Investigator Payments Organization © 2011 TRIO GRUP
  8. 8. CRO PRODUCTS AND SERVICES Laboratory Organization Site Management OrganizationHealth Outcome / Pharmacoeconomic StudiesData Management / Statistical AnalysisSite Coordinator ServiceMedical Translation ServiceMedical Writing; Abstract / Article / Poster Service © 2011 TRIO GRUP
  9. 9. CRO PRODUCTS AND SERVICESTraining OrganizationMarketing Questionnaire ServiceOrganization and Support to Social Responsibility Projects © 2011 TRIO GRUP
  10. 10. CRO PRODUCTS AND SERVICES MonitoringTRIO GRUP CRA-s perform comprehensive site management and monitoring activities to include the following types of monitoring visits: • Pre study qualification visits, Initiation visits, Interim monitoring visits, Close out visitsAll activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with all applicable regulations and protocol requirements. © 2011 TRIO GRUP
  11. 11. CRO PRODUCTS AND SERVICES Project ManagementOur project management team works closely with the scientific team to ensure the smooth progression of your clinical trial. Our Project Managers work effectively and diligently to manage all critical aspects of the study to ensure on-time delivery of results, within budget and with the highest possible quality output. Our team will work with you on all aspects of the trial from the first regulatory submissions through to closeout and final reporting to help you and your project succeed. © 2011 TRIO GRUP
  12. 12. CRO PRODUCTS AND SERVICES Project ManagementWe provide:• Frequent and timely reports to our sponsors.• Training for CRA-s and site personnel on the protocol, CRF-s, SOPs, ICH- GCP.• Constant review of CRA-s work to assure highest standards and consistency• Management of Budget and Project Timelines © 2011 TRIO GRUP
  13. 13. CRO PRODUCTS AND SERVICES Data ManagementWeb-based e-trialsElectronic Data Capture in full compliance with 21CFR part 11Case Report Form annotation and Data Handling ManualBlind and independent double data entryOn-demand comprehensive data validation reportsFull electronic Audit TrailComputer-generated and fully tracked Data Clarification Forms (queries). © 2011 TRIO GRUP
  14. 14. CRO PRODUCTS AND SERVICESThe paramount responsibility of TRIO GRUP CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity.In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused.In summary the TRIO GRUP CRA plays a major role in the successful conduct of a study. The relationship developed between the CRA and the site staff is such that there is a focus on open effective communication with the CRA providing training and support thus ensuring patient safety, data quality and maximizing patient enrollment. © 2011 TRIO GRUP
  15. 15. TRIO GRUP CLINICAL RESEARCH STANDART OPERATING PROCEDURES (SOPs)Safety Reporting SOPPatient Information Sheet/ Informed Consent Form Preparation and Procedures SOPNon-Drug Supplies Management SOPProtocol Writing SOPMedical Writing SOPTranslation SOPSite Selection SOP © 2011 TRIO GRUP
  16. 16. TRIO GRUP CLINICAL RESEARCH STANDART OPERATING PROCEDURES (SOPs)Monitoring Visit SOPInvestigational Product Management SOPCRF Design SOPEthics Committee Submission SOPPatient Recruitment and Retention SOPDocumentation SOPTraining SOP © 2011 TRIO GRUP
  17. 17. TRIO GRUP CLINICAL RESEARCH STANDART OPERATING PROCEDURES (SOPs)Site Management Organization SOPLaboratory and Medical Center Organization SOPPost-Marketing Surveillance Studies SOPProject Management SOP © 2011 TRIO GRUP
  18. 18. TRIO GRUP CLINICAL RESEARCH QC/QABasic CRA Training: ICH-GCP, local regulations and projectmanagement and refrehment trainingsTrio Grup Clinical Research SOP trainingBasic Therapeutic Area TrainingOther Trainings: ICH-GCP refrehment, time management,project management, budget management, staff management etc. © 2011 TRIO GRUP
  19. 19. CONTACT DETAILS İlker Kürkçü, Pharm General Manager Tel: +90 532 635 45 15 TRIO GRUP CONTRACT RESEARCH ORGANIZATION Farilya Business Center No: 8 31 (5. Floor) Ufuk Üniversitesi Street, Söğütözü Çankaya / ANKARA Phone: (+90) 312 284 50 85 Fax: (+90) 312 284 50 86 © 2011 TRIO GRUP