Advantages: Scale to support global mega-trials on-demand
Mega-trials (trials with 10,000 or more globally-distributed patients) are becoming more prevalent in many therapeutic areas. Timaeus provides the capabilities critical to supporting mega-trials:
- Scaling capacity without degrading performance
- Providing this on-demand as enrolment expands
- Enabling fast, 24/7 access worldwide
Scaling clinical trial capacity without degrading performance
Timaeus’ architecture enables it to scale processing and data capacity by simple expansion of a pool of distributed computing resources. This scaling model has been proven for years by large-scale financial and Internet utility providers. It is cost effective; it maintains consistently high performance at all scaling levels; it also reduces risk of catastrophic outage as it scales.
Timaeus implements this scaling model in an intelligent model that matches study hierarchy. Not only does this make distributed computing efficient; it also reinforces ICH-GCP standards for clear designation of a Trial Master File (TMF), protection of patient privacy, and enforcement of data blinding.
Providing on-demand capacity in line with enrolment
Due to their large scale, clinical trials often have longer periods of site setup and enrolment. Timaeus’ ability to perform “in-flight” maintenance without downtime enables operations teams to cost-effectively expand capacity on-demand: as sites are provisioned, patients are enrolment, and visit data are captured. They can do the reverse to reduce to reduce resource costs as site shut down during study closeout.
In addition, Timaeus enables research organisation to temporarily expand capacity during high-usage periods. This is especially important to supporting the more frequent soft locks and interim analyses used in mega-trials.
Enabling fast, 24/7 access worldwide
Timaeus provides all users real-time access to all the data they need. It is designed to enable this from any location, enabling sites to operate from nearly any location with full EDC/CDM functionality. This is especially important for mega-trials as they routinely need to locate sites across many remote locations in order to enrol the number of patients required by their protocols.
