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Data Management: a key factor in data quality

The constant increase in the volume of clinical data and the emergence of new technologies in the medical field over recent years necessitate a robust quality assurance system to ensure the highest level of data quality.

How can data quality be ensured? Which actions should to be considered? Which tools need to be implemented?

Clearly, for efficient data cleaning, efficient tools are needed…

1. Efficient data capture solutions

First, it is crucial to have highly intuitive electronic solutions to capture patient clinical data. Some eCOA providers such as Kayentis offer a wide range of solutions to improve clinical trials. Kayentis proposes the use of tablets and smartphones, and also an electronic pen for some specific populations.

2. An integrated web portal

The captured data are then recorded using web portal solutions. This integrated web portal is the data manager’s main tool. It enables real-time monitoring and data management throughout the study. In this way, the generation of queries for investigators and the subsequent data cleaning can be conducted directly from the web portal.

At Kayentis, the Clin’Form web portal is more than simply an electronic data capture tool – in an emergency it is also able to handle paper versions of patient questionnaires.

3. A solution for opening database reconciliation

In addition to the use of the web portal, the data manager may also have to reconcile different databases (e.g. sponsor and eCOA provider databases). Inconsistences between databases can be tracked and resolved throughout the study.

…but so is efficient communication between stakeholders!

Communication between the sponsor, the study sites, and the eCOA provider is a key element in preventing and solving problems:

• the eCOA provider has to actively communicate with the sponsor to keep track of data cleaning, and provide data metrics and status updates.

• the eCOA provider also has to work closely with the clinical team for efficient and informed data cleaning.

Together, this teamwork between the various partners helps to ensure compliance to the key study dates.

The data management teams of the eCOA provider and the sponsor are integrated to fully support clinical trials and ensure high data quality. Thanks to its data management team, its expertise, and its innovative tools, Kayentis can ensure a very high level of data quality for your clinical studies.

To read more about our Clin’form web portal, please click here.

Delphine Parmentier, Clinical Data Manager – Kayentis

 

Last update : 30 January 2017