Portfolio

CTMS (Clinical trials management system)

Country: Germany
Industry: Medicine
Short description:

Provides specialized modules for management of clinical trials.
Study data is centralized through import and synchronization of study / patient information from EDC system collecting patient data. The application provides management of study centers, patients, visitations, SAEs (serious adverse events), QLQs (quality of life questionnaires), laboratories, laboratory parameters and certificates, essential documents.
Module for management of study materials distribution to study centers supports definition of materials, registration, tracking, approving of transactions (purchasing of materials, transfer to study centers, delivery to patients, scrapping etc.), definition of material usage per study and study center, gives foresight for date of reaching of defined limit and date of absence of material in study center based on number of patients in the center and patients planned visits.
Financial management for study projects is also available including payment milestones, distribution of milestone payments, current status of patients recruitment and statistical evaluation for the period of achieving of planned patients number, management of account groups, calculation of planned and actual closing balance per department, listing of month incomes/disbursements per project/department, calculation of performance per resource.
The application provides support for arranging of payments for investigators (payment groups, definition of payment per study, review of payment status, calculation of payments per visit and bonus payments).

Project duration: 90 man months
Technologies used: Java2 SDK (Servlets, JDBC, JAXP, Swing, JavaMail, JNMI, WebStart), Tomcat, MySQL, XML, HTML, OpenOffice API, Cryptography (Blowfish, RSA, SHA1, MD5), Aspell dictionary
OS: any OS supported by Java2 1.4+ and MySQL