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Clintracc :

Introduction

Life-sciences and Pharmaceutical companies conduct clinical trails, bio-availability and bio-equivalent studies as part of their core activities. These companies worked under the strict guidelines defined by USFDA, HIPPA and other international regulatory bodies.

Successful completion of the studies to a large extent depends upon the volunteer subject identification process. Various factors like health history, previous study participation details, adverse events as some of the important criteria’s based on which subject are enrolled into a particular study.

Clintracc is a user friendly biometric based product which will enable companies to manage their study related activities more efficiently. Subject management, study & period management and transfers are some of the key modules that form an integral part of the system.

Challenges

Major challenges faced by the Pharmaceutical companies while doing a bio-equivalence study or bio-availability study are listed below:

	System/Process should ensure that the volunteers should not be participating in multiple studies simultaneously within an organization or across organizations.
	Volunteer should have a pre-defined gap in terms of time between studies conducted within an organization and across organizations.
	Volunteer identification based on ID or documents were not dependable.
	Fingerprint based identification process did not work because of accuracy issues and hygienic issues.
	Maintaining or tracking information pertaining to a study that was done in the past during a regulatory audit.

The organization was looking forward for a unique solution to overcome the challenges provided above.

Solution

To help companies meet their challenges, it was critical to find a reliable IT solution. After considering various possibilities it was decided that biometrics could be the right choice to offer a reliable solution for the Life sciences and Pharma companies.

Benefit

Clintracc can help Life sciences and Pharma companies to conduct their studies according to the guidelines provided by the governing body. As for the individual companies are concerned, there is significant value addition in terms of operational efficiency.

Services

	Product Development
	Custom Application Development
	System Integration
	Process Outsourcing
	Consulting

Products

	Clintracc
	CalMan
	SLIMS
	Document Management System
	Biometric Solution