Data collection often involves sources who are remote from the pharmacovigilance system such as clinical trial centres, subsidiary offices and distributors. It is not always desirable to give direct access to the pharmacovigilance database for these users.
PV-Express is an extension to our PV-Works database that allows you to create data entry forms as PDF files that may be distributed to these sources or placed on a website. The case data is entered by the reporter (using Adobe Reader software which is both free and universally available). The data is submitted via a secure internet link and is transcribed automatically into the database in minutes.
PV-Express combines a number of elements to deliver a remote data collection system that co-exists with PV-Works:
- PDF Forms
- Any number of data collection forms may be designed for different data types and these can be in any language including most European languages, Kanji, Arabic, Mandarin Chinese as well as English.
- Data forms are linked to the PV-Works database when they are created so that they can use the same vocabulary lists as the PV-Works application.
- Administration software
- The administration software controls multiple versions of each master PDF form, populates forms with vocabulary data and manages the forms submitted by users.
- Deployment options
- PDF forms can be distributed as standalone files for data entry or can be placed on a website for access via the internet.
- Submission receiver
- Completed PDF forms are submitted via the internet to the PV-Express database. Security has been addressed with a secure connection and data encryption.
- Import to PV-Works database
- Submitted PDF forms are imported to the PV-Works database where they will create a new case. As the data is imported from forms that have been designed in a non-English language, it is translated to English. The PDF form itself is attached to the case as a record of the source data.
- Our customers use PV-Express
- to collect cases from local offices in countries where the expected volume does not justify PV-Works deployment
- to allow partner companies and distributors to submit cases
- to provide an adverse event form that the public can complete