Clinical trial contract research organization (cro) turkey
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© 2011 TRIO GRUP
description
Transcript of Clinical trial contract research organization (cro) turkey
© 2011 TRIO GRUP
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
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
PROJECTS THERAPEUTIC AREAS
OncologyCardiologyRheumatologyPediatryNeonatalogy
© 2011 TRIO GRUP
THERAPEUTIC AREAS OF EXPERTISE
OncologyCardiologyRheumatologyPsychiatry/PsychologyEndocrinologyNephrologyOphthalmologyNeurology
© 2011 TRIO GRUP
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
CRO PRODUCTS AND SERVICES
Clinical Trials and PMS Studies ;Protocol Design and AdaptationCRF / e-CRF DesignPIS / ICF ve DesignSite SelectionEthic committee / MoH Submission FileProject ManagementMonitoringInvestigator Payments Organization
© 2011 TRIO GRUP
CRO PRODUCTS AND SERVICES
Laboratory OrganizationSite Management Organization
Health Outcome / Pharmacoeconomic StudiesData Management / Statistical AnalysisSite Coordinator ServiceMedical Translation ServiceMedical Writing; Abstract / Article / Poster
Service
© 2011 TRIO GRUP
CRO PRODUCTS AND SERVICES
Training OrganizationMarketing Questionnaire ServiceOrganization and Support to Social
Responsibility Projects
© 2011 TRIO GRUP
CRO PRODUCTS AND SERVICESMonitoring
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
CRO PRODUCTS AND SERVICESProject 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
CRO PRODUCTS AND SERVICES
We provide:
• Frequent and timely reports to our sponsors.• Training for CRA-s and site personnel on the protocol,
CRF-s, SOP's, ICH- GCP.• Constant review of CRA-s work to assure highest
standards and consistency• Management of Budget and Project Timelines
© 2011 TRIO GRUP
CRO PRODUCTS AND SERVICESProject Management
CRO PRODUCTS AND SERVICES
Web-based e-trialsElectronic Data Capture in full compliance with 21CFR
part 11Case Report Form annotation and Data Handling ManualBlind and independent double data entryOn-demand comprehensive data validation reportsFull electronic Audit TrailComputer-generated and fully tracked Data Clarification
Forms (queries).
© 2011 TRIO GRUP
CRO PRODUCTS AND SERVICESData Management
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
TRIO GRUP CLINICAL RESEARCH STANDART OPERATING
PROCEDURES (SOPs)Safety Reporting SOPPatient Information Sheet/ Informed Consent Form Preparation
and Procedures SOP Non-Drug Supplies Management SOPProtocol Writing SOPMedical Writing SOPTranslation SOPSite Selection SOP
© 2011 TRIO GRUP
Monitoring Visit SOPInvestigational Product Management SOPCRF Design SOPEthics Committee Submission SOPPatient Recruitment and Retention SOPDocumentation SOPTraining SOP
© 2011 TRIO GRUP
TRIO GRUP CLINICAL RESEARCH STANDART OPERATING
PROCEDURES (SOPs)
Site Management Organization SOPLaboratory and Medical Center Organization SOPPost-Marketing Surveillance Studies SOPProject Management SOP
© 2011 TRIO GRUP
TRIO GRUP CLINICAL RESEARCH STANDART OPERATING
PROCEDURES (SOPs)
TRIO GRUP CLINICAL RESEARCH QC/QA
Basic CRA Training: ICH-GCP, local regulations and project management and refrehment trainingsTrio Grup Clinical Research SOP trainingBasic Therapeutic Area TrainingOther Trainings: ICH-GCP refrehment, time management, project management, budget management, staff management etc.
© 2011 TRIO GRUP
CONTACT DETAILSİlker Kürkçü, Pharm
General Manager
www.triogrup-cro.com
Tel: +90 532 635 45 15
© 2011 TRIO GRUP
TRIO GRUP CONTRACT RESEARCH ORGANIZATIONFarilya Business Center No: 8 31 (5. Floor)
Ufuk Üniversitesi Street, SöğütözüÇankaya / ANKARA
Phone: (+90) 312 284 50 85Fax: (+90) 312 284 50 86
