The new QCTMS system provides continuous quality control of clinical trial data to identify and address risks. It monitors 100% of study data in real-time to evaluate risks before patient safety or data integrity are compromised. This allows corrective actions to be initiated proactively. Compared to traditional quality tools like audits that review a small sample, QCTMS allows more effective quality management through automated risk reporting and evaluation of all study data. It can reduce monitoring costs by intelligently coordinating resources and ensuring quality issues are found and addressed early.

1. QCTMS ®
The new Generation of Electronic Trial Management Systems
Quality Controlled Trial Management System
for Drug & Medical Device Studies

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. 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. 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. 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. 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