Clinion™ is a 21 CFR Part 11 validated Intuitive Electronic Data Capture (Intuitive EDC) and Clinical Data Management (Paper Study) platform.ClinionTMis focused on reducing the new product time-to-market for Pharmaceutical, Biotech and Medical Device Organizations by providing a highly configurable and user-friendly Clinical Trials Application.
Clinion™ is easy to use and configure and does not require any hardware and software requirements from the client.It is available online and can be securely accessed from anywhere by authorized users.
It is available online and can be securely accessed from anywhere by authorized users.
On-Demand, Web-Based EDC & CDM.
21CFR Part 11 compliant.
Intuitive Data Capture features.
High system scalability [Multisite, Multi User Trials].
Paper Trial Mode.
Easy Study CRF design and Edit Checks setup.
Customized Reporting and Dash Boards.
Multiple formats for Data Extraction.
Medical coding using Standard Medical Dictionaries.
Edit Checks configuration
Clinical Data Management
Study Documents Repository
US FDA 21 CFR Part 11 validated system
Electronic Signatures & Records
Secure, Role Based Access
Intuitive User Friendly Interface
Easy to configure study builder and edit checks
Intuitive CRF pages for ease of data entry
Hybrid EDC & CDM Solution
EDC and CDM studies can be deployed from the same system
Common Study Builder and Administration
System Validation & 21 CFR Compliance
Clinion™ has been audited for 21 CFR part 11 compliance
Software development compliance audit has also been carried to ascertain standard Software Development Life Cycle (SDLC) methodologies have been followed and implemented
IQ, OQ and PQ for the system has been done and system has been found to be fully compliant to these
Performance Qualification will be done for each study subsequent to configuration and before the study is moved to live.
Data Security and Integrity
The database can be accessed only through the application
The application has very strict access controls in place
Data extraction has to be done through the application
All access keys are encrypted and stored in the database
Data transfer from client to server is using secure protocols
Data integrity is managed by system design, which does not allow deletion of any data in the system and logs all changes and access
Clinion™ is available as an On Demand service (SaaS) and also as an On-premise licensed system.
Users simply need to sign up and create their account
They can login and configure their study and edit checks
They can deploy this study to a staging server and subsequently to a live server
Data capture can take place. This is the same for an EDC and a CDM Study.
Once study is completed they can lock the study and extract the data
The data on the server is archived and stored securely with adequate backups as per regulatory requirements.
Clinion is also licensed as an On Premise system
A perpetual license with a fixed set of studies is available for clients
The software will be deployed at client server along with validation and training
A helpdesk is available to clients requiring help in configuring studies or requiring any other technical help.
All upgrades and patches are made freely available to clients as per the support plan.