Kuantum Cro St V021


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Company Profile, Kuantum CRO

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Kuantum Cro St V021

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