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Clinical Data Management

 Clinical Data Management

“Innovative treatments, created by experienced professionals in a comfortable environment” – Unknown

The aim of clinical research is to put in place a process to support/refute a hypothesis or to develop a new hypothesis. Clinical trials are invaluable to healthcare. They are a means to assess the effectiveness of a proposed medication, understand the behaviour of a condition better and establish effective treatment methods for a given disease. Clinical trials recruit those individuals that meet a specific profile to begin the experiment. Trials can be specific or broad in nature, it is entirely dependent on the research question that is to be answered and/or hypothesis to be tested.

Manual Clinical Data Management is Laborious 

Evidently, data plays a focal point in clinical research. Before research even begins, participants need to be recruited and ethical approval sought. The bulk of data collection takes place throughout each respective phase of a trial. A case report form (CRF) or a questionnaire (or both) are used to collect main trial data such as information on participants, their response to the tests being performed and so forth. In addition, most trials will use certain validated health measures/scores and tests that need to be recorded on the CRF.

A CRF or questionnaire(s) can be between 5-50 pages. Essentially, there are large quantities of data to collect. The data collection needs increase substantially from each phase, as the further a trial goes, the more participants it recruits.

Most clinical trials hire administration staff to manually input the vast amount of data into an electronic system. On other occasions, the research team do it themselves. In either case, manual and double data entry is time consuming, which delays the access to and analysis of data.

Furthermore, high volumes of paper require storage comes with cost implications. Notwithstanding the difficulty in retrieving records, as the number of documents increase as well as maintaining solid version control.

Delivering a Robust Clinical Data Management System

Document Capture has collaborated with a plethora of institutions on their clinical research, delivering an entirely robust, automated and efficient clinical data management system. Selections of institutions we have worked with include The University of Sheffield, The University of Birmingham, Liverpool School of Tropical Medicine and more.

Our work with the respective universities began at the design stage, specifically the design of the forms they’ll be using to collect data. The forms being used are already given ethical approval and thus we do not edit the form in any way that would invalidate the approval. Instead, our designers give the forms a make-over, making the forms user friendly, easy to complete and set for automated data capture. Moreover, there are options to deploy documents on a tablet, mobile device, a web-based platform or for a digital ink pen.

Data is captured from all clinical trial documentation using a scanning solution that extracts the relevant data from each field and exports the raw data to an electronic system. The digital ink pen that is ideal for remote capture, converts handwriting into digital text and exports data in real time to an electronic system. If mobile, tablet or web-based options are being utilised, the data collection is amalgamated with the paper data capture. The elimination of manual data entry has wide ramifications such as cost savings of no longer requiring admin staff and time savings- the research team can spend more time on the research itself, rather than data entry.

All paper documentation is digitised and stored electronically, making it easier to search for and retrieve information.

Lastly, the clinical data management dashboard facilitates a visual and interactive data analysis engine. We understand research teams want clinical data available swiftly, thus the dashboard can receive data from the webmobile and paper as and when data is submitted. Monitoring data in near-real time is invaluable to any research project as it allows the identification of adverse events, test results and so forth. The dashboard uses effective illustrative formats to visualise data.

Read the case study of Birmingham University for a practical insight into the applicability Document Capture’s clinical data management toolkit.

 

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