Kuantum Cro St V021

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Information about Kuantum Cro St V021
Health & Medicine

Published on June 10, 2009

Author: serhan

Source: slideshare.net

Description

Company Profile, Kuantum CRO

Company Presentation 28 May 2009 Brief V.0.2.1

AGENDA Our Mission Our Values Our Goals Organizational Structure Teams Therapeutic Areas Current projects

Our Mission

Our Values

Our Goals

Organizational Structure

Teams

Therapeutic Areas

Current projects

OUR MISSION To become the most valuable service provider in the field of clinical research in Turkey and neighbouring regions View slide

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. View slide

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

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

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

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 Business Development Office Management Clinical Research Logistics Clinical Research RO Department Office Maintenance Depot Lead Import Controller Depot Assistant SCRA CRA CTA CLINICAL REASARCH AND LOGISTICS DIRECTOR ADMINISTRATIVE DIRECTOR Customs broker Translation Office (Sworn Translator) Office Manager Financial Officer CHIEF EXECUTIVE OFFICER QA Department IT (E- Çözüm ) Finance & Accountancy Legal Issues Security Courier (E- Çözüm ) Others (e,g. Utilities services, Travel offices) Print Copy Center

ORGANIZATIONAL STRUCTURE Clinical Trials Group Clinical Research Logistics Administrative Group

Clinical Trials Group

Clinical Research Logistics

Administrative 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

• 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 Research In 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.

Clinical Research

In 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: The ICH GCP guidelines FDA Regulations European Directives Local Regulations

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

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 & Logistics Activities Total area 121 m2 + 25m2 (h=2.7m) Cold Room 2 – 8 °C (49,5 m ³ ) Freezer -21 to -16°C (max -50 °C , 540L) Ambient Room 15 to 25°C (76 m ³ )

Warehose & Logistics Activities

Total area 121 m2 + 25m2 (h=2.7m)

Cold Room 2 – 8 °C (49,5 m ³ )

Freezer -21 to -16°C (max -50 °C , 540L)

Ambient Room 15 to 25°C (76 m ³ )

ORGANIZATIONAL STRUCTURE Clinical Research Logistics Warehose & Logistics Activities In compliance with GMP and GDP standards with internal SOP s • 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

Warehose & Logistics Activities

In compliance with GMP and GDP standards with internal SOP s

• 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

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

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.

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

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 Feasibility Database of the investigators in different therapy areas Conducting the feasibilities efficiently Business development

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

Feasibility

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

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

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 facility together with growing CRO business and requirements E xpanding 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

Further development and expanding of the warehouse facility

together with growing CRO business and requirements

E xpanding 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

From all of us here at Kuantum we would like to thank you for your attention

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