Timaeus and oncology studies

"Of all therapeutic areas, eDC should bring the most benefit to oncology clinical trials, yet here the deficiencies of eDC are often the most ruthlessly exposed."

Cancer remains a challenging area not only for medical research, but also in the practical aspects of conducting efficient, ethical, safe and rapid clinical trials. Oncology clinical trials are often medically, scientifically and statistically complex. They are particularly demanding of data management and have proved beyond the capabilities of many electronic Data Capture (eDC) systems.

The increasing popularity of adaptive trial design methodology in cancer trials provides further practical challenges that are beyond contemporary eDC systems.

Timaeus is well proven in oncology studies, from small Phase I through to large Phase III studies. It is increasingly used in complex adaptive trial design oncology studies.

Just some of the features and benefits that make Timaeus so ideal for oncology studies are:

• Fast for sites to use in both eDC appliance and eDC web modes, which is vital when the sites have high volumes of data, adverse events, toxicity criteria, and concomitant medications to enter
• Very flexible and able to manage a multitude of cohorts, arms, and trial extension and modification arrangements, including varying individual sites within a study.
• Able to 'control' patient enrolment/allocation into different cohorts or arms
• Handles the most demanding of validation checks, e.g. derived cross-checks across multiple visits
• All checks fire in real time, and the client has the freedom to select which are seen by the site and which are seen by a data manager
• Integrated, powerful medical coding, with full auto-coding — including synonyms and special character/stop management — essential to efficiently manage large numbers of terms common in most oncology studies
• Local and central laboratory and specialist laboratory management, including remote loading and view by sites through Timaeus eDC
• Defined and customisable data review and reporting
• Rapid interim data snapshots without need for interim database locks
• Pick and mix paper CRFs with appliance or web based eDC at sites within a study
• Portable data management &mdash enterprise power DM on a laptop at sites for rapid access to data through traditional paper-based CRF data capture

In a busy oncology clinic, where patient wellbeing and management are so important, site staff need a system that is quick, efficient and suits them. These features make Timaeus an ideal system for oncology studies.