Calyx Info

Process
CLIX

Solutions

	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.

Need for precise and scientific data to support the drug approval process calls for Data Management software that ensures - that the data collected is error free, that it is validated and resolved, and that, the entire process is transparent and auditable.

Calyx eClinical Data Management application software is very exhaustive, provides an end to end solution and is perfectly aligned to your Clinical Trial data management needs within a time and budget frame. The application is totally customised to incorporate your typical work flows and processes, yet adhering to regulatory compliance needs.


	CRF Creation
	Makes form creation –so easy! Quick Form creation facility in the software allows copying CRF from previous trials with proviso for incorporating changes / customising it for current Trial. The process not only saves time but is highly productive as it is error free.

	Data Capture
	Direct data capture from the trial Site through internet and / or Double data entry ensures error free data capture! Validation checks on various data elements helps in error detection which is highly useful in ensuring that data is clean at the time of final analysis.

	Query Resolution Process
	Getting queries resolved is key to validated data. The system provides facilities to resolve queries on-line, view queries which are resolved. And, wherever more verification is required the coordinator can even induce a query. A completely automated Query resolution process.

	Interface to Statistical Packages
	Cleaned and Validated data can be sent into statistical packages for statistical analysis. Calyx solutions are currently working with SPSS, SAS.

	Audit Trail
	The database keeps track of changes and operations performed which can be viewed in the form of an audit trail. Audit trail views can be organised to suit different audit purposes. They can be data specific, user specific, or as per audit needs.

	Statutory Compliance
	The system is compliant with 21 CFR 11 and other statutory requirements.

	To know more and for a personal discussion, please get in touch with us .click here