eCOA set up & Design
This stage is the ‘hidden part of the iceberg’. This is the first step in eCOA studies, defining eCOA strategy, translations, validation steps, tools, and connection.
We use robust processes and tools to adhere to the timelines of the study set up, and to define required specifications for worldwide diffusion, regulation and data management. The success of the trial depends primarily on this phase.
KAYENTIS’ eCOA EXPERTISE ALLOWS TO:
- Get a scientific expertise on choice of instruments / endpoints strategy
- Reduce and optimize setup time:
- Reusable library of instruments
- Automatic integration of translations in devices
- Automatic screen generation for proofreading
- Ensure appropriate validation of all components.
At the forefront of innovative solutions, Kayentis enables sponsors and CROs to implement an efficient eCOA strategy. Because one-size-fits-all is not the right approach, our complete range of devices allows us to adapt to the therapeutic area, the patient age, the study duration, and the study budget.
To support site PROs / ClinRos / ObsRos: Clinicians, patients and caregivers complete entries directly on a Tablet as part of the patient visit.
To support eDiaries: Patients complete entries directly on a Smartphone at home or anywhere at anytime.
To support mainly eDiaries: Patients complete directly on their own laptop.
Available for any use: easy-to-use for some specific populations and therapeutic areas.
To collect data from a range of medical devices, such as glucometer or spirometer.
Clin’form is the clinical portal solution of Kayentis. Combining our innovative technology and our extensive experience, Clin’form enables real-time monitoring and management of your data, throughout your study.
- For easy monitoring of clinical trials
- Real-time management
- Consistency check
- Instant scores / alerts (visible in the portal / sent via email
- Query management
- Interoperable system
- Easily connects to any EDC / CDMS
- SaaS mode portal
- Data management
- DCF management
- Hosting based on a robust and dedicated infrastructure
- Backup servers ensure total security and availability of our applications
- Hourly data backups ensure full protection of your data
- Disaster Recovery Plan in place
- Full audit trail, 21 CFR part 11 compliant
Electronic Informed Consent Form - eICF
As the first stage in enrollment in a clinical trial, the consent form play a key role in patient engagement. Kayentis has chosen to add an electronic Informed Consent Form (eICF) to its eCOA solution to improve patient engagement from the moment of inclusion in a clinical trial.
Simplifying e-consent, SecureConsent® – developed by our strategic alliance partner – offers an easy-to-understand consent form, with audio of the approved consent in the patient’s language, embedded information for specified concepts, and electronically captured handwritten signature capability.
SecureConsent® – developed by our strategic alliance partner – offers several benefits for a patient’s understanding and compliance, while maintaining adherence to regulations:
- Improves patient comprehension and ultimately compliance and commitment
- Improves consistency and quality with regard to delivery, tracking, monitoring and archiving of all relevant informed consent information in a searchable database
- Provides trial staff with a real-time high level overview of the trial consent process at all sites
- Improves the quality and efficiency of interactions between patients and site staff
- Simplifies education, consenting and re-consenting, and ultimately the enrollment process with greater retention of patients throughout the trial
- Improves speed and effectiveness of the consent process