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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)
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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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