In order to support scientific research, Diagram has developed the following, commercially available products.
The e-DREAM (Digital REgistry And Management) is a web-based electronic Case Report Form (e-CRF). The distinguishing feature of e-DREAM lies in the fact that study and registration forms can be flexibly and dynamically developed. Within e-DREAM users are able to define work-flows, table structures and form lay out (among others), without the aid of a programmer. In addition, the error-check module and count module can also be used flexibly and dynamically. The user/administrator is able to ‘program’ the checks and use the checks in forms themselves. e-DREAM also contains a letter module that can generate letters based on the data in the database. e-DREAM meets ICH-GCP guidelines and is accessible via the website of Diagram.
Successfully using Diagram’s database services for years for our post market clinical registries.
Web-based Clinical Study Randomisation
Diagram has developed a web-based randomisation program. A study-specific entry screen is developed for each study, where the relevant data can be entered. If need be, stratification factors can also be entered or inclusion and exclusion criteria can be determined. The randomisation is then confirmed via e-mail to the client.
The electronic Clinical Research Management System (CRMS) has been developed for supporting sites and involves a centrally consultable database which contains all patient registration, planning and financial control in relation to the payment of investigator fees, per trial.
A specific Research Monitor Management (RMM) program has been developed for Clinical Research Associates (CRA’s) and Clinical Trial Monitor’s (CTM’s) in order to support their major tasks in clinical trials: protection of the rights and well-being of all included patients, verifying the reported trial data on accuracy and completeness, and to check whether the trial has been conducted in compliance with the approved protocol (amendment(s)), with Good Clinical Practice (GCP) and with the applicable regulatory requirements.