Calyx Info    
 
 
 
 
 
 
 
Partnering Change Management’ Calyx Info goes that extra mile to ensure that the client is comfortable with our solutions. That's added value for our customers.
CLIX provides a Layered exchange platform that allows cross pollination of ideas and suggestions between differing levels within the User Organisation, differing levels within Calyx project team and across the two teams as well. Yet it preserves a common approach and thought process to ensure all solutions are towards the final defined goal.
'On Going Services'- A bouquet of these services is mutually discussed and finalized depending upon the actual needs of the customer.
 
 

eBio Equivalence is a comprehensive and versatile application software tailored to effectively manage the entire bioequivalence study process.

 

The key processes - Volunteer Data Base management, Volunteer enrolment and eData Capture are perfectly encapsulated in our eBio-equivalence Software. The application completely automates the procedure. It speeds up the process given the time critical path for their execution, ensures that they are error proof and pro actively guides the sequence.

 

Some of the salient features are:

 
 
 
Volunteer Registration
 

An active subject database maintains critical subject data with personal information, demographics, proof of identity, medical examination records and enrolment history. All very crucial to the success of subject management for studies.

   
Study Enrolment
 

Enrolment of Subjects for specific studies is supported through application of inclusion/exclusion criterion as the subjects are selected for a particular study. Application enforces the statutory norms where required.

   
Authentication
  Authentication is crucial. Bio Metric and Bar Coding technology authenticates subjects. Finger print matching and identity cards with Bar codes and photographs are used at every interface, touch point.
   
Sample Tracking
 

Bar code technology is used for Sample tracking. Each sample drawn is clearly tagged with sample information in terms of: study identification, subject-id, sequence and time. The link is carried through Centrifuge, Seperation and Segregation process.

   
Data Capture and Analysis
 

Data can be read directly from Lab systems (pre stored at specified locations) and populated on to CRF with no manual intervention. Appropriate data validation controls can be incorporated in CRF to ensure data accuracy.

   
Audit Trail
 

The Data Base has details of changes and operations performed. Audit trial views can be organised to suit different purposes. They can be data specific, user specific or defined as per audit needs.

   
Statutory Compliance
 

The system is compliant with 21 CFR 11, Indian GCP, ICH-GCP guidelines.

   
  For further details and a personal discussion, please get in touch with us.click here
   

Home About Calyx Info Organisation Process Solutions Services Careers Contact Us
    Terms of Use - Copyrights 2008, All Right Reserved. Calyx Info Pvt. Ltd.