Our eCOA solution, Clin’form, is a unique digital platform to collect and manage patient data in clinical trials. Powerful and customizable, Clin’form can adapt and evolve according to trial specificities, and can integrate external applications to guarantee efficiency as well as data quality and completeness. User-friendly, Clin’form simplifies the clinical trials experience for patients, sites, and sponsors.
Ensure the success of your eCOA study
by using robust & adaptable technology
for data collection on provisioned device
- Wherever you collect patient data, our attention on ease-of-use aims to improve patient/caregiver compliance in data collection, helping to improve the quality of data collected.
- To adapt to each protocol and fit the needs of each project our Clin’form App is available on a wide choice of tablet devices provided by Kayentis with different screen sizes and which are compatible with a range of medical devices.
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for real-time monitoring and management of your data
Clin’form Web Portal is our sponsor interface for real-time monitoring and management of your data, throughout your trial.
- For easy clinical trial monitoring: real-time management, consistency check, instant scores/alerts (visible in the portal)/query management.
- Interoperable system: easily connects to any EDC/CDMS, SaaS mode portal
- Data management: alerts, DCF management
- Hosting based on a robust and dedicated infrastructure: back-up 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
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to collect data from other sources
- Our platform is interoperable to connect and capture data from varied sources (e.g. medical devices, wearables, eICF, companion).
- We can connect from either our own medical apps and devices or yours.
CLIN’FORM WEBCOA BACK-UP
At home with virtual support or on-site with staff support, our webCOA back-up has key advantages
- Convenient for patients and site staff
- No paper needed
- The source data are maintained on the same platform
- Ready-to-use – easy set up
- Guaranteed quality of collected data
- Easy access: same login and password as for the device
Simplify your eCOA trial implementation and conduct
thanks to streamlined services
We support small and large pharmaceutical companies, and CROs throughout a clinical trial to ensure success with a full range of services.
With our dedicated teams in 3 geographical zones (Europe/US/Asia), we provide sponsor teams with support for:
- Site set-up and initiation
- Training (sponsors, site staff, direct training and ‘train-the–trainer’ trainings)
- Management of translations and text validation (with key partners such as Mapi, RWS & Transperfect, or your own partner)
- Back-up solution management
We assign a team of data managers to each trial to set up the specifications, manage the data throughout the trial, and ensure a clean final database.
Our strong data management capabilities include:
- Data cleaning – detection, resolution, & management of inconsistencies
- Data change management
- Data transfer
LOGISTICS & HELPDESK SUPPORT
Global logistics capabilities with experience in 79+ countries
- Support for customs clearance
- Preparation and shipment of devices from Europe and China
- Use of world-class courier companies to ensure on-time delivery
24/7 multilingual Helpdesk for sites and patients:
- English, Spanish, German, French, and Italian included in the core offer
- 20 other languages available on demand
Hosting and data security
- Hosting and archiving in Europe
- Our medical team provides scientific guidance and can help reflect on the selection of the most appropriate questionnaire or improve the design of you eDiary.
- As developing our expertise is a key driver, our medical team collaborates with key institutions such as the ePRO consortium, as well as with experts, KOLs and patients advocacies.