The better the it-solution
the more successful the study.

Planning and executing studies is an essential aspect of clinical research. One is often confronted with significant problems from the initial point of project planning. The devil often is in the details: Recruiting a sufficient number of patients, who fulfill the criteria for a study, is often complicated and protracted.

Education, consent, as well as the planning of therapies and operations are further essential steps, followed by the extraction of blood samples, storage and the analysis as well as the documentation of all of the steps involved. Study reporting can easily become a never-ending task. Kairos bridges the gap between biobanking and study management and helps you combine the relevant data from both areas in a sensible and productive manner.

The main task that CentraXX Study Management faces thus lies in structured data management. Such a structuring is the foundation for saving data related to the studies, reporting and analysis. Further demands, such as a system-wide process support through an integrated runtime-workflow-system, have been implemented for quality-assured study execution. This makes it possible for CentraXX to display and run all relevant agreements from the study plan and study design of population-based, treatment-related, or clinical studies. Important further-reaching functions regarding the use of IT-supported procedures are the possibilities of ad-hoc reporting, automation of documentation, and system-supported monitoring of study results.

The recruiting of patients as well as a premature termination of the study (once conditions of termination have been reached) are accounted for by CentraXX as well. Relying on these system tools, CentraXX supports the execution of multi-centered studies including their integrated procedures, and enables the greatest amount of transparency during run-time.

A precondition for a campus-wide recruiting is the registration of all studies in one portal. This is why CentraXX provides a comprehensive registering function and sorts the studies by wide-spread diseases. The register can also be used to publish filtered study information on selected websites. The study register can be configured flexibly according to a customer’s demands. Different profiles, with different documentation points consisting of different characteristics and vocabularies allow representing any type of study.

The central storage unit for data is the patient-centered study record, which deposits study protocols in a structured way, and with a clear assignment to the respective test-person.

The CentraXX study record is an extension of the HIS EPA into research. The adaptation to new studies takes place through the use of predefined and customizable eCRFs Electronic Case Report Forms are the foundation for study documentation. which are offered via application layer. The course of a study can be defined as so called swim-lane models and visualized as such. The controlling, orchestration, and documentation is carried out with the integrated workflow engine. Checking on the status of a specific patient is possible any time with task lists, status-flags, and the recording of activity. The information for extracted biospecimens, the patient consent, and other information complete the study record as the central medium for checking on and exchanging all relevant information regarding the test persons.

In addition to the study record as the information and function container, CentraXX has an integrated discussion forum. This channel allows for a role-overreaching organization of tasks and an exchange of ideas relating to the test persons. The study forum offers activity lists which can make references into study workflows, blogging functions for communication purposes and synchronized status information from the current study.

Taking into account the high demands on the quality of documentation for study management, the study forum offers an important tool. New discoveries, which may allow for new conclusions must be referenced, and the impact that can be created for the entire development of the study must be shown.

Besides this, in research not only the decision for a therapy and the result are important, but also the underlying intention, meaning the thoughts put into diagnosis, and the reasons that led to the therapy count. The integrated study forum goes farther than simply looking into the letters of findings, and offers optimized possibilities for getting an understanding of the thought patterns of others. In final result, the classic functions of a web-forum were applied. This bears the advantage that one can directly emerge into a discussion revolving around a study, an involved patient, or an examination. This carries great weight for the involved personnel. Key words, blogs, topics, as well as images, films, and links can be added to the entries. Publication assistance and tools for an independent modelling complete the CentraXX Study Management.

Phase I: Project / Study Definition

Beginning from the initial point of study definition, CentraXX can help you. It is thus simple to run queries, and conduct analyses for the feasibility of a given study. The number of test persons for comparable studies conducted in the past can be checked, allowing estimates for how current recruiting might go. Checks like these allow you to exclude low performers during the study definition phase.

Phase II: Clearances

Once studies have been cleared by the Ethics Committee or also by your sponsor, you can add related documents to the study, and access them yourself or make them available to any of your partners at any needed time. Already during this phase, it is possible to deposit the letters of consent in structured form in the system.

Phase III: Project-/Study Facility

Using an integrated web-based administration tool, you can choose the study participants and define which resources may be needed for a study, without having to have special software skills. A completely defined study is published in the CentraXX Study Registry, allowing all persons with the necessary access rights to immediately see important study information, such as inclusion and exclusion criteria.

Phase IV: Patient recruiting

CentraXX provides you with a recruiting agent. The de-identified admission records are searched, or as is the case in oncology, the patients that are in tumor conferences, given they match with all inclusion criteria, are displayed as potential study participants in de-identified form. This gives you the opportunity to make the treating physicians aware of the study and to ask for assistance with the recruiting.

Phase V: Project-/Study execution

A central element is the eCRF Designer. This allows the creation of forms that are needed for study documentation.

This is the reason why the electronic Case Report Forms put to use in CentraXX support the entire life cycle of eCRFs, including design, test, use phases as well as archiving with version numbers. The eCRF-module functionally corresponds to the form management module known from clinical workspaces.

The outlined design comes through in the basic consideration of CentraXX for the realization of this important tool.

In addition to the functions provided by the e-CRF designer and its integration into the areas of workflow/rules engine and data dictionary, the study management offers a range of further significant functionalities, in order to comprehensively document trials compliant with the Medicinal Products Act (in Germany called AGB):

  • Dsicrepancy Management and Reporting
  • CRF-Monitoring
  • Job-controlled double checking
  • Documentation of adverse events

In addition to documenting and monitoring a trial, it is important to be able to receive management information at any desired time. You will want to be able to query and analyze all important key figures regarding your institute. The reporting tool by CentraXX can assist you to this end.

Phase VI: Study Results

The display of study results does not simply occur in graphs and tables within the system, but rather is embedded into a comprehensive matrix of similar results that were gained from other studies. This allows you to carry out benchmarking, which is important for further examinations.

Phase VII: Clearance of Results

Simply put, you want to be able to publish results easily. This is how you have come to know the writing of study reports. The CentraXX module Publication Assistance will function similarly. We are developing a tool in this area, which allows you to choose all important results and export them to word processing or spread sheet programs.