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Company Profile, Kuantum CRO
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Company PresentationCompany Presentation
28 May 200928 May 2009
Brief V.0.2.1 Brief V.0.2.1
AGENDAAGENDA
• Our MissionOur Mission• Our ValuesOur Values• Our GoalsOur Goals• Organizational StructureOrganizational Structure• Teams Teams • Therapeutic AreasTherapeutic Areas• Current projectsCurrent projects
OUR MISSION
To become the most valuable service provider in the field of clinical
research in Turkey and neighbouring regions
OUR VALUES Integrity: We ensure full compliance to all global and local regulations with
appropriate customer management
Respect for people: We recognize the importance of the individual and we also give priority to the protection of the rights, safety and well being of the study subjects according to the Dec. of Helsinki.
Customer focus: We are the eye of our customers in clinical research
Innovation: We believe that there is always room for improvement and that new ideas will help us grow and develop.
OUR VALUES Teamwork: We believe a key to higher efficiency is through working in highly motivated
and dynamic teams
Leadership: By sharing knowledge and recognizing and rewarding success, leaders empower those around them
Performance We aim for continuous improvement in our performance to ensure that integrity and
respect for people are never compromised
Quality Our company philosophy is based on the inherent belief that quality and reliability are
the most important components in any world class company
OUR GOALS Meeting and exceeding customer
expectations by..
• Improving cost effectiveness and time management• Collating and providing high quality data and service in a timely manner• Maintaining the security of data and systems at all times• Evaluating the staff competency through regular performance appraisals • Implementing and following SOPs under the guidance of the Kuantum’s
Quality Management System
OUR GOALS Developing the company to meet the
changing needs of the research sector by…
• Introducing Turkey as a potential growth area for clinical research• Continual updating and analysis of relevant local market factors• Further enhancing the efficiency of staff through training and shared
knowledge• Improving the Quality• Management Systems to meet the ISO 9001standards
ORGANIZATIONAL CHART
Suppliers
BusinessDevelopment
OfficeManagement
Clinical Research Logistics
ClinicalResearch
RODepartment
OfficeMaintenance
Depot Lead
ImportController
Depot Assistant
SCRA
CRA
CTA
CLINICAL REASARCH AND LOGISTICS
DIRECTOR
ADMINISTRATIV E DIRECTOR
Customs broker Translation Office( )Sworn Translator
OfficeManager
FinancialOfficer
CHIEF EXECUTIVE OFFICER
QA Department
IT
(E-Çözüm)
& FinanceAccountancy
Legal Issues
Security
Courier
(E-Çözüm)
( , . Others e g , Utilities services )Travel offices
Print Copy Center
ORGANIZATIONAL STRUCTURE
• Clinical Trials GroupClinical Trials Group• Clinical Research LogisticsClinical Research Logistics• Administrative GroupAdministrative Group
ORGANIZATIONAL STRUCTURE Clinical Trials Group
• Phase I, II, III, IV, Observational, compassionate use• Phase I and BE / BA studies collaboration with University Ph I unit• CRF and Protocol Design• Medical Translations• Feasibilities• Site Identifications and Qualifications• IEC and RA Submissions and Approvals• Newsletter Preparation
ORGANIZATIONAL STRUCTURE Clinical Trials Group
Clinical ResearchIn compliance with ICH/GCP standards• Selection of site and investigators• Initiation, monitoring and close out of study sites• Progress reporting• Safety reporting and monitoring• Follow-up of EC and RA reporting• Design and production of study newsletters• CRA and Investigator training• Investigators' meeting organization• Financial agreement preparation for the investigators and institutions.
ORGANIZATIONAL STRUCTURE Clinical Trials Group
CM SOPs following: CM SOPs following:
• The ICH GCP guidelines
• FDA Regulations
• European Directives
• Local Regulations
ORGANIZATIONAL STRUCTURE Clinical Research Logistics
Separate
• Cool room (temp, humidity controlled)
• Ambient room (temp, humidity controlled)
• Incoming/Quarantine area • Outgoing/Re-labeling area
• Returned/Unused/Expired room
ORGANIZATIONAL STRUCTURE Clinical Research Logistics
Warehose & Logist ics Activit ies
Total area 121 m2 + 25m2 (h=2.7m) Cold Room 2 – 8 °C (49,5 m³) Freezer -21 to -16°C (max -50°C, 540L) Ambient Room 15 to 25°C (76 m³)
ORGANIZATIONAL STRUCTURE Clinical Research Logistics
Warehose & Logistics Activit iesIn compliance with GMP and GDP standards with internal SOPs
• Import license Application• Importation/ Exportation / Customs clearance• Storage / Handling / Monitoring• Distribution• Labeling and Re-labeling• Destruction• Arrangement of Central Lab and shipment of samples• Purchasing Clinical Trial Supplies
ORGANIZATIONAL STRUCTURE Clinical Research Logistics
CRL SOPs following: • GDP • GMP• Local regulations• Kuantum CM SOPs
ORGANIZATIONAL STRUCTURE Quality Assurance
• Independent then the operational groups (Clinical, Administrative and Logistics)
• In compliance with the ISO9001 Standards
• Follows the global regulations and directives
• Internal Audits and Reporting
• Corrective and Preventive Actions and Reporting
• Control of Non Conforming Product and Service
ORGANIZATIONAL STRUCTURE Administrative Group
IT:
• ISA server, File server, Mail Server with trend Micro virus protection
• All employees have laptops with password protection
• Back up with IBM cassettes every day, every week and month.
ORGANIZATIONAL STRUCTURE Administrative Group
• Human resource and Training• Finance and Accountancy• Legal Issues• Office Maintenance
TEAMS
• Regulatory • To keep good company image with the ECs and RA• only people who contact the ECs and RA during the
approval process• Member of Clinical Research Organisation
• Feasibil i ty • Database of the investigators in different therapy
areas• Conducting the feasibilities efficiently• Business development
THERAPEUTIC AREAS EXPERIENCE • Cardiology• Oncology• Haematology• Psychiatry• Respiratory• Nephrology• Immunology• Anesthesiology• Gastoentrology
• Rheumatology• Dermatology• Paediatry• Vaccine• Ear Nose Throat Diseases• Gynaecology• Infectious Diseases• Neurology
CURRENT ON GOING PROJECTS Clinical Trial Group• Atrial Fibrillation 18 Sites• GIST 10 sites• Colon Cancer 5 sites• Vaccine 5 sites• Asthma 17 sites• Ulcerative Colitis 10 sites• Ulcerative Colitis 3 sites• Lung Cancer 14 sites• Thalesemia 4 sites• CML 10 sites
Logistics Group • Colon Cancer 5 sites• Atrial Fibrillation 18 Sites• Asthma 17 sites• UC 10 sites• UC 3 sites• LC 14 sites• Aptuit – TBD• Vaccine 5 sites
OUR FUTURE PLANS
• Further development and expanding of the warehouse facilitytogether with growing CRO business and requirements
• Expanding the clinical research related logistics support to other CROs and Pharma companies
• Providing Q.A. service for the clinical research sector
• Providing training service for the clinical research sector
THANK YOU!
From all of us here at Kuantum we would like to thank you for your attention