1Overview and Exclusivity of OVIS

India is a major hub of Life Science Research. The vast population of this third world along with skilled Pharmacy and IT skill set make it the perfect lab for the new Drugs Research and testing. The vast population provides unlimited human volunteers for such studies. India has numerous CROs Contract Research Organization. Towards end of 2006, CROs in Ahmedabad contacted us for a solution for the issue of Cross Participation Tracking CPT. The term CPT is used for volunteers who participate in more than one drug testing studies simultaneously or without the prescribed time gap between them. CPT can be a risk to the volunteer lives as well as create erroneous results in drug studies. Such professional volunteers create risk for the CROs. The subscriber CROs upload the data to this database after dosing. New volunteer is checked across this database by the finger prints. The match shows the eligibility status. Inforcom Technologies started the net based CPT Service - OVIS (Online Volunteers Information System) in 2007. The service spread to other CROs. This protected the CROs from professional volunteers as well as reduced the number of Adverse Drug Reactions and erroneous reports. Gradually all the CROs of Ahmedabad joined the service. Our success in Ahmedabad followed by the presentations in Mumbai, Pune, Chennai made the CROs join OVIS. Further CROs in Goa, Coimbatore and Aurangabad have come on board along with the ones in the National Capital Region. This service today has reached to the status of an essential component for Clinical study. Indian and foreign auditors inquire during the audits if the CRO uses OVIS !
It assures the safety of the volunteers, leading to acquiring the future studies license.

2Benefits of OVISTM ownership

-OVIS A gateway to CROs in India

OVIS is a daily routine at over 35 CRO locations across India. The CPT process is a documented SOP - Standard Operating Procedure. From the screening team to the Directors are involved in its regular use. This offers a tremendous opportunity to interact with the management and the routine functioning of a CRO. Offering of new services, software, data analysis, ancillary products, essential supplies, etc. are on our expansion opportunity list. As all 35 locations are under one umbrella, involvement in tasks of new policies and practices is what we are involved in. OVIS clientage is a strong in-road for our future business expansion.

3 Other Applications

Inforcom Technologies have entered the CRO market at an early stage. We offer other products and services to the CROs too. Each CRO needs an internal database to manage the confidential data of the volunteers and the drugs test process with the results. They further monitor the internal eligibility for volunteers. VPMS (Volunteers and Project Management System) is an Intranet based product developed by Inforcom. VPMS controls the Volunteer Management Modules as well as the Clinical Operation Modules offering Screening Dosing and its related data control. Full Demographics of volunteers with Photograph and Finger Prints offer detailed reports for Audit and essential Project documentation purpose. VPMS is a validated and compliant system following the USFDA CFR 11-2 compliance guidelines. This software application is installed and operational at many CROs across India.
The CRPMS (CRO Project Management System) is another value added application that can be offered to the CROs. This is a documented application with combination of Intranet and Internet modules. CRPMS offers features to manage multiple projects at CROs with HR resources, Time lines, Progress Monitoring etc. The web component of the same offers a seamless but controlled access to the sponsors of the trials / studies. They can be informed about the progress / status of the project. OVIS along with VPMS and CRPMS offer a suite of products essential for CROs. A typical CRO Project Progress flow for Healthy Volunteers / Patients. We do not offer data analysis and Lab services. There will be other management and clearance related manual tasks. These areas are left unmarked)
   
 
Online Volunteers Information System is a web based service to CROs for the eligibility verification of participating volunteers. 'Volunteers play musical chair with CROs' (Economic Times, Ahmedabad, Aug 19, 2005) or tend to do CRO hopping for commercial benefits. This is a burning issue for CRO - the issue of 'Cross Participation'. A Volunteer has to be inactive for a stepulated time after participating in a Clinical Trial at a CRO. Only after this time a volunteer can participate in a new project. An early participation might cause adverse effect to the volunteer. Sometimes these volunteer might show incorrect clinical trial result. This can also cause daamge to the clinical trial as a CRO point of view. OVIS is an effort to address this issue of cross participation. Based on the practise of self discipline and honest data sharing, OVIS is not only beneficial to the other participating CRO (as per a common thought) but also to the data contributing CRO. The participating CROs contribute to this system with the correct information of the volunteers and their eligibility time frames. Volunterer information contributerd by a CRO will be of immense importance to other participating CROs. The correct data submission by a CRO instantly helps it (the same CRO), as a download file is also generated which can further update the local volunteer database of the CRO. This can lead to multifold daving of various resources like manpower, medical materials, drugs, investment and time as certain uneligible volunteers are not tested till they clear the specific time period. As thumb rule, the 'INELIGIBLE' volunteers are stored on the web based system. As a volunteer become re-eligible after the 3 months time (or other specified) of blood regeneration, he/she is made re-eligible. The permenantly ineligible volunteers are always stored in the system.  

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