Quality Controlled Trial Management Service (QCTMS)

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Quality Controlled Trial Management Service (QCTMS)

  1. 1. QCTMS ® The new Generation of Electronic Trial Management Systems Quality Controlled Trial Management System for Drug & Medical Device Studies
  2. 2. Quality Risk Management by GCP-Service The conduct of clinical studies in men can only be justified if these are ethically appropriately planned, accomplished, evaluated and reported scientifically. These requirements call for implementation of functional quality management systems in all departments involved in the conduct and monitoring of clinical studies. Regulatory requirements are increasing and complexity of study designs is enlarging. Hence, many sponsors and CROs are aware of the fact that the existing quality assurance activities like audits alone are no suitable methods to ensure the required quality of clinical trials. In fact only 5-10% of all investigators are audited. The large size of studies and the high number of study data as well as the limited resources in the quality assurance departments make an effective control of data quality by auditors impossible. Compared to the traditional quality management approach quality risk management focuses on systematic quality issues based on the comprehensive sets of information. GCP-Service has developed a Quality Controlled Trial Management System (QCTMS®), which offers much more than other usual Clinical Trial Managament Systems (CTMS). QCTMS® is provided as an effective risk management tool in accordance with ICH Q9 and ISO 14791. 100% of the study data are controlled continuously in order to identify and evaluate risks before patient safety and data integrity is endangered. By using QCTMS® the overall quality of a project can be controlled and improved in an extremely cost effective way. Risk Management via QCTMS® according to ICH Q9 QCTMS® Initiate Corrective Define Identify Report Evaluate and Preventive Risk Risk Risk Risk Actions Documentation
  3. 3. Advantages of QCTMS® 1. Improvement of Quality Risks are evaluated independently from experience, workload, time pressures, lack of resources or personal criteria of participants involved. 2. Relief of Project Management Only essential issues rise the attention of the Project Management to ensure a secure and effective way of Project Management. 3. Flexible System QCTMS® can be adapted to each clinical study, sponsor, SOP, risk and level of risk. 4. Information of different Process Participants According to the risk or risk level different participants can be informed by QCTMS®. 5. Reasonable Use of Resources Monitoring visits and audits can be navigated by intelligent resource coordination. 6. Continuous Control of Study Progress Reporting of actual study status incl. budget status. 7. eCRFs can be connected to QCTMS® to evaluate Realtime Data Continuous control of integrity of relevant study data. 8. QCTMS® can be used for Electronic Maintenance Possibility to use QCTMS® as Trial Master File. 9. Easy in Use QCTMS® does not require intensive training for Project Managers and CRAs. 10. Besides all other Advantages: Expenses for Implementing QCTMS® are paying off quickly Users are saving money by saving manpower and time.
  4. 4. Benefit of Quality Risk Management by QCTMS® Currently available CTMS tools have been developed predominantly to provide Project Managers with all information required to monitor the study status and plan further progress. However the resulting overload of information does not improve the quality of studies because keeping an overview of so many data is time consuming and nearly impossible. As a result important issues are often overlooked. In contrast QCTMS® supports your Project Management by helping to identify and evaluate risks before problems occur - even without expensive maintenance and extensive training. Audits, for the most part, identify quality issues when it is too late to take preventive action. QCTMS® is a flexible online tool which takes over the quality control and reports risks according to the needs of the project team automatically. Preventive actions can be initiated. Saved human resources can be used for other tasks. Working hours and study budgets for Clinical Monitoring and Project Management can be reduced significantly. Quality Assurance Tools Diagnostic Clinical Trial Quality Controlled Audits & Assessment & Management Trial Management Checklists Tools (manually) Systems (CTMS) Systems (QCTMS®) Working Hours Innovation & Money Saving Potential
  5. 5. Tailor QCTMS® to your study Individual risk factors and levels of risk factors can be specified to initiate corrective and preventive actions to the particular requirements of your individual study. - Informed Consent Process - Investigator Payment - SAE Reporting Timelines - Budget Overview - Recruitment Rates - and many additional factors more - Query Rates Different risk levels trigger automatic - Primary and Secondary Endpoints alerts to your Project Team. With only one - Number of Protocol Deviations click the overall Study Status Report is - Non-Compliance generated and sent to your Project - Monitoring Frequency Management. Process of risk reporting, evaluation and alerting by QCTMS® Management Summary Quality Assurance Project Management Report Risk Evaluate Risk Generate Alerts Minimum System Requirements Windows XP, Adobe Acrobat Reader Version 9.x, Windows Media Player Version 11, Processor 1 GHz, 512 MB RAM, DSL-Internetzugang (DSL Internet access), Internet Explorer Version 8 / Firefox Version 3.
  6. 6. Development of innovative products needs innovative technologies. For Sponsors QCTMS® increases considerably the transparency between you and your Clinical Research Organisation (CRO) because you can have access via login to critical study data anytime you want. Thus you will be able to receive information about the current status of your study as well as the processing by the CRO. For CROs QCTMS® gives you the opportunity to convince the sponsor of the high quality services that you provide by granting the sponsor access to their own study. The sponsor will get a better understanding of risks and possible issues throughout the study. Moreover, you will be able to show your client how well your Project Management cope with the whole process. This increases faith on both sides which will lead to long-term relationships. Additional Services Online Demo • Clinical Monitoring • Project Management You want to get a first impression of • Data Management QCTMS® ? Get in touch with us. • Quality Assurance We will arrange an appointment and • Auditing show you the capabilities of QCTMS® • Online GCP-Training via Webex. For further information and details please visit our website. GCP-Service International Ltd. & Co. KG Tel. +49 (0)421 24 68 78 26 Fax +49 (0)421 43 48 659 Anne-Conway-Str. 2 Email info@gcp-service.com 28359 Bremen, Germany Web www.gcp-service.com

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