CLI NOV

Introduction

Clinical Studies are needed to get drugs approval. They are implemented in veterinary practices situated in several countries/states. Such studies usually last for at least six to twelve months. Paper forms are filled-in in the practices and collected at the end of the study. After verification, two operators will do a separate data entries. Any discrepancy between those data entry will be corrected.

Principle

Vets fill in paper forms using a digital pen.
After connection, the digital pen send the information to the server. Data is immediately available through a secure web site.

Off site monitoring is performed on the images of the pages. A pre treatment (business orientated) of data assist monitors by alerting on missing or illogical data, and provide an overview of each case as well as of the global project. In addition, data and image of each form page are available.

Monitoring and project management

For each form filled in, an exact image of the page is available, it can be use to correct OCR errors. After OCR validation step, data is available and presented online for project management as well as for immediate usage using summary tables and graphs.

Intermediate data analysis are then possible.
The website allows for an accurate follow up of individual case, allowing for immediate contacts with the vet in case of problem.

Second data entry and queries management

Second data entry can be done in the website, using forms matching the paper form to improve accuracy. This data is then compare with the digital pen data to identify (and correct) any typing error.

In our experience, the number of queries created during the data management process is greatly reduce due to computer assist monitoring (alerts + online data presentation helps monitors to identify missing or illogical data at an earlier stage).

Data exportation

A file containing all the data (ASCII, CSV, XML . . .) can be downloaded and used for data analysis.

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