Kuantum Cro St V021

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


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.


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


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)


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


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