OUR CLIN'FORM eCOA SOLUTION


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

 

CLIN’FORM APP
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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CLIN’FORM WEBPORTAL
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

 

DOWNLOAD OUR BROCHURE

 

CLIN’FORM CONNECT
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.
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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
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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.

 

PROJECT MANAGEMENT

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

 

 

DATA 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 75+ 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
CONTACT THE HELPDESK

 
 

MEDICAL SUPPORT

  • 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.

 
 
 

Resources


ALL RESOURCES →

eCOA set-up #whitepaper

How to anticipate eCOA complexities and ensure a successful launch? Setting up a study with… | Read More

eCOA challenges of long term studies #whitepaper

How to anticipate eCOA complexities in multi-year studies & develop best practice to support sites?… | Read More

Make it simple: Use a single device! #infography

Discover the 3 key advantages of using a single device for both on-site and home… | Read More

eCOA Training: how can we improve the sites’ and patients’ experience? #whitepaper

Focused on eCOA training, this white paper transcribes the discussion from one in a series… | Read More

Make clinical trials an enjoyable experience: use a small tablet device! #infography

A small tablet is the perfect choice between a smartphone and a “classic” tablet. A… | Read More

Oncology Case Study: Global Phase III Oncology Study – Melanoma

With its strong experience in eCOA market, Kayentis introduces its new case study about oncology… | Read More