Randomization and Trial Supply Management
Captivate® RTSM
By integrating randomization into Captivate® EDC, you enhance your ability to make the process faster, easier, and truly unbiased. Captivate® RTSM fully integrates with your data collection process to allow for easy and intuitive set-up.
Captivate® RTSM supports any type of randomization from simple to dynamic algorithms and offers full support for double blinded trials, including kit management, kit replacement, and emergency unblinding.
Kit admins have full control over the kits for a trial, including uploading new kit ID numbers, assigning kits to clinical sites, setting email warnings for low kits, and viewing which kits have already been assigned.
Captivate® RTSM Features
- Simple Randomization: the system randomly selects treatment for randomized subjects
- Permuted-Block Randomization: the systems balances treatment arms within a block so the same number of subjects are included in each treatment arm. Blocks of different sizes are combined to make up a randomization list. The system randomly chooses between blocks with equal probability
- Stratified Randomization: the system allows the configuration stratification variables to balance treatment arms between prognostic characteristics
- Minimization / Dynamic Randomization: the system assigns participants to treatment groups ensuring balance across prognostic factors (e.g., age, gender, disease severity). Unlike traditional randomization methods, minimization dynamically adjusts the treatment assigned for each new subject based on the current imbalance in the study arms
- Blinding and unblinding control with emergency unblinding capabilities
- Integrated supply management with kit assignment and tracking capabilities