Clinical Trial Management System

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A clinical trial management system ( clinical trial management system ; CTMS ) is a software category that in the biotech and pharmaceutical industries , is applied to the management of clinical trials to support. With the help of a CTMS, the study manager and the study team are supported in the planning, preparation, implementation and evaluation of clinical studies. The CTMS database is partially linked to a business intelligence system, so that study data can be linked and evaluated with data from other data systems in the company.

Functions

The exact scope of functions of a CTMS differs from product to product. In addition, the requirements for each implementation are different, so that many CTMS solutions have extensive configuration options. The scope of functions of a CTMS sometimes overlaps with other computer systems used in clinical development, such as B. Document Management Systems, Electronic Data Capture, IVRS , Adverse Event Reporting.

Typical functions of a CTMS:

  • Address and contact management
  • Subject and patient management
  • Randomization
  • Case Report Form (CRF) tracking
  • Adverse Event (AE) Tracking
  • Clinical Supply Tracking
  • Clinical Cost Tracking
  • Document tracking
  • Reporting

Through the use of internet technologies and the implementation of the software as a centralized web application, geographically distributed study teams can access a common database. Field staff can access the central study management system via a secure radio connection (e.g. UMTS , WLAN ). To enable you to work without an existing data connection, some providers offer separate special software modules that can be installed on mobile devices and whose data can be synchronized with the central database.

Requirements in regulated environments

Since CTM systems are used in regulated environments that have to meet specifications such as Good Clinical Practice or 21 CFR part 11, there are special requirements for the operation of such systems. In addition to a validation of the system operation and the availability of suitable work instructions, detailed training of the persons entrusted with the use of the CTMS is essential. Due to the complexity of the systems and the global distribution of users, blended learnings or pure e-learnings are increasingly being used in addition to classic face-to-face training .

Quality controlled study management system

A Quality Controlled Study Management System (Quality Controlled Trial Management System; QCTMS ) but should, in contrast to CTMS for the project manager (Project Manager) continuously evaluate risks, so the quality and to inform the study status. Here, work is carried out in accordance with the requirements of quality risk management according to ICH Q9 - Quality Risk Management.

Quality risk management

Quality risk management is a systematic process for the assessment, control, communication and monitoring of risks that can influence the quality of drugs in the entire development process. The process of risk management has existed outside the pharmaceutical industry (e.g. automotive industry, financial industry) for a long time to save resources and standardize processes. In the context of clinical studies, the term “risk” refers to a possible risk of a violation of the goals formulated in Good Clinical Practice (GCP). Conducting a study in accordance with GCP is intended to protect the well-being and rights of study participants and to ensure the integrity of study data. Compliance with the GCP goals requires a study-specific analysis of the possible risks. This should be done as early as possible in the course of study planning and preparation. The risk analysis should result in the planning of an overall package of quality assurance measures for the clinical trial. So it should be clearly defined:

  • What risks are expected?
  • How are these identified and evaluated in the course of the study?
  • How can these be minimized through corrective and preventive actions (CAPA).


Clinical trials are becoming more and more complex and larger, as are the regulatory and safety-related requirements. The number of official inspections is growing steadily, which means that those responsible for the project and quality assurance (QA) have to process a vast amount of information in order to fulfill the task of quality assurance. In small clinical studies, risks can be controlled manually, but this is usually no longer possible with a study size of more than 10 study centers. The amount of data to be controlled is too large, which increases the risks and the quality or compliance with GCP can no longer be guaranteed. That is why automatic computer-aided solutions such as QCTMS are now being offered to evaluate the multitude of data that could represent a risk and to report any risks immediately in order to then initiate corrective and preventive measures. Computer-aided automation enables resources to be used more sensibly, thereby significantly reducing the costs of developing medical products and drugs.

Functions

The exact scope of functions of QCTMS differs from study to study. The requirements for each implementation are different because the risks have to be redefined again and again. Many risks are similar (e.g. GCP compliance), but some depend on the target criteria of the respective clinical trial. QCTMS solutions must have extensive configuration options. The functionality of a QCTMS overlaps with other computer systems used in clinical development such as B. Document Management Systems, Electronic Data Capture, IVRS, Adverse Event Reporting. The main functions of QCTMS:

  • Subject and patient management
  • Risk assessment
  • Risk notification
  • Evaluation of risks such as protocol violations, number of queries, compliance with timelines, reporting of safety data (SAEs), primary and secondary target criteria
  • Budget control
  • Reporting the project status
  • Document management

Through the use of internet technologies and the implementation of the software as a centralized web application, geographically distributed study teams can access a common database. Field staff can access the central study management system via a secure radio connection (e.g. UMTS, WLAN) and report risks, which are evaluated by QCTMS and reported to the project managers in a standardized manner.

Requirements in regulated environments

Since QCTM systems are used in regulated environments that must meet the requirements of the GCP regulation or 21 CFR part 11, there are special requirements for the operation of such systems. In addition to a validation of the system operation and the availability of suitable work instructions (Standard Operating Procedures; SOPs), detailed training of the people assigned to use the QTMS is essential. In contrast to other systems such as B. CTMS, however, QCTMS is very easy to learn because it does not serve to display a great deal of information, but rather directs the focus on the essential information that could pose a risk to the success of the study. In addition to generally available software offers, some companies also use self-developed systems (e.g. based on an Oracle database, Lotus Notes or Microsoft Excel) for quality risk management.

Well-known CTMS solutions

  • Oracle Clinical
  • Perceptive IMPACT
  • AkazaResearch OpenClinica (Open Source)
  • Oriam eTrialManager
  • GCP service QCTMS
  • BSI CTMS

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  • I Q9 QUALITY RISK MANAGEMENT
  • ISO14971; Risk management for medical devices
  • Andreas Grund: "Quality risk management in clinical trials for small and medium-sized sponsors", dzkf 3 / 4-2010
  • Andreas Grund: "A risk worth taking", International Clinical Research Issue 18 November 2010

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