In order to support scientific research, Diagram has developed the following, commercially available products.
The eDREAM (Digital REgistry And Management) is a web-based electronic Case Report Form (eCRF).
We configure your eCRF to ensure it matches your trial protocol and that it allows you to gather all the necessary data needed to answer your Research question.
Study and registration forms can be flexibly and dynamically developed. We’ll configure custom workflows, table structures and form layouts (among others).
In addition, the error-check module and count module can also be tailored to your trial. The user/administrator is able to ‘program’ the checks and use the checks in forms themselves. eDREAM also contains a letter module that can generate letters based on the data in the database. eDREAM meets ICH-GCP guidelines, is ISO/IEC 27001 validated and is accessible via our website.
Successfully using Diagram’s database services for years for our post market clinical registries.
Web-based Clinical Study Randomisation
Your customised database may include randomisation. A study-specific entry screen is developed for each study, where the relevant data can be entered. If need be, stratification factors can be entered or inclusion and exclusion criteria can be determined. The randomisation is then confirmed via email 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.