Clin'form eCOA

Clin'form eCOA is an electronic Clinical Outcome Assessment platform developed by Kayentis, designed to support clinical trials across multiple countries and patient populations. It is intended for use by sponsors, clinical research organisations, and site staff managing studies of varying complexity, from small trials to large-scale global studies involving over 10,000 patients.

The platform handles multiple questionnaire types, supports diverse data collection modes, and integrates with external clinical systems to fit into existing trial workflows.

Platform Capabilities

• Questionnaire support: Accommodates all eCOA questionnaire types, including PRO (Patient-Reported Outcomes), ObsRO (Observer-Reported Outcomes), ClinRO (Clinician-Reported Outcomes), and diary formats.
• Population flexibility: Suitable for all age groups, from pediatric to older patients, and supports studies ranging from a small number of participants to over 10,000 patients across all geographic regions.
• Scalable data handling: Capable of managing datasets of any size while maintaining performance and scalability.
• Data collection modes: Supports provisioned tablets or smartphones, patients' own smartphones (BYOD), web browser access, and interview-based data entry.
• System interoperability: Integrates with external clinical systems including IRT systems, patient portals, and clinical data lakes.
• User experience: Designed to be accessible and engaging for both patients and site staff.

Key Features

• eCOA: Supports all eCOA study types, whether conducted on-site or remotely at home, regardless of protocol complexity.
• Televisit: Includes an embedded televisit feature within the eCOA application, enabling remote patient-site interactions when in-person visits are not possible.
• Patient engagement modules: Provides multiple features aimed at maintaining patient compliance throughout the study.
• eConsent: Offers an embedded electronic consent solution to manage patient consent from the start of the study.
• External system connections: Connects Clin'form with other electronic clinical systems used in a trial, such as IRT systems, patient portals, and clinical data repositories.

Recent Developments

• Kayentis has partnered with RWS to address data variability in neuroscience and other complex disorder clinical trials, combining Clin'form eCOA technology with expert rater training to improve data confidence in CNS studies.

Clin'form eCOA is built to operate across multiple countries and is designed to adapt to a wide range of clinical trial protocols, supporting both on-site and remote data collection within a single platform.