Study Management
At Calyx, our focus is ensuring that your recruitment goes to plan, even when mid-study challenges arise.
Anticipating the Unexpected
Our experienced team of statistical design and trial supplies consultants work to understand and analyse your unique protocol requirements and develop a strategy to meet them initially while allowing for future flexibility if and when your study needs change.
Using our extensive experience from working with a range of protocol designs over many decades and in all therapeutic areas, we aim to identify risk and anticipate future needs so that we can recommend an approach that is both adaptable and future-proof.
Study Manager
Calyx IRT enables sponsors to easily make changes to the IRT design as and when needed. Through standard functionality, immediate changes can be made to meet common challenges faced during the course of a trial, from something as simple as an investigator correcting a patient’s DOB, to increasing enrolment caps to reflect changes in recruitment.
If your protocol allows for changes to study design, the IRT system can be designed to change immediately, for example adding new doses for new patient cohorts, or closing a treatment arm following a safety review.
Cohort Management
Calyx has built hundreds of cohort studies, including adaptive designs where the dose for successive cohorts is determined by the analysis of previous cohorts.
Data Quality
Calyx IRT minimizes data errors to improve clinical trial data quality by:
- Minimizing data errors
- Reducing ambiguity during data capture
- Enabling accurate questions and quality translation
- Guiding sites on how and when to enter patient data in alignment with the protocol
- Removing the risk of errors through data entry validation in real-time, with helpful error and warning messages
Calyx IRT further ensures data quality through integrations with other key eClinical systems, such as EDC, ePRO, and central labs, reducing the study team’s data reconciliation efforts and resulting in faster time to data analysis. And Calyx IRT is configured to reduce the risk of accidental unblinding, randomization imbalance, or mis-dispensing, resulting in increased protocol compliance and high data quality.
Additionally, through Calyx Patient Manager, investigative sites can make changes to patient data with immediate effect, based on permitted changes that are agreed upon by the sponsor during protocol design, which contributes to higher quality data.
Seamless Integrations
By integrating Calyx IRT with other eClinical systems, sponsors reduce the need for data duplication and reconciliation at the end of the trial. Calyx enables everything from simple IRT-to-EDC integrations to more complex, blinded central lab integrations and electronic patient reported outcome (ePRO) scoring.
