full issue - Association of Biotechnology and Pharmacy
full issue - Association of Biotechnology and Pharmacy
full issue - Association of Biotechnology and Pharmacy
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Current Trends in <strong>Biotechnology</strong> <strong>and</strong> <strong>Pharmacy</strong><br />
Vol. 5 (3) 1353-1361 July 2011, ISSN 0973-8916 (Print), 2230-7303 (Online)<br />
1354<br />
These leading CROs are performing costeffective<br />
bio-equivalence / bioavailability (BE/<br />
BA) studies on various dosage forms <strong>of</strong><br />
pharmaceuticals <strong>and</strong> to conduct testing services<br />
in the areas <strong>of</strong> clinical research, pre-clinical<br />
(animal) studies, clinical reference lab services,<br />
agriculture sector, bioscience, environmental<br />
assessments <strong>and</strong> analytical testing <strong>of</strong> a wide<br />
variety <strong>of</strong> products (1). One <strong>of</strong> the goals <strong>of</strong> the<br />
CROs is to help its customers reduce the cycle<br />
times <strong>of</strong> new drug discovery by connecting<br />
different stakeholders who are geographically<br />
distributed using automated clinical trial<br />
processes by leveraging technology solutions<br />
available on different platforms.<br />
In general, the clinical data are collected<br />
through a variety <strong>of</strong> data acquisition systems like<br />
Web Forms, telephone interactive voice response<br />
(IVR), fax, clinical devices, hospital information<br />
<strong>and</strong> management systems/labs <strong>and</strong> provide a<br />
central storage for the collected data. The data<br />
are critical <strong>and</strong> sensitive <strong>and</strong> hence the security<br />
<strong>and</strong> privacy needs are high. The data collection<br />
<strong>and</strong> management is a process that is regulated<br />
by regulatory authorities <strong>and</strong> goes through<br />
regular audit checks. Life expectancy <strong>of</strong> the data<br />
is driven by customers as well as regulatory<br />
authorities. It is traditionally kept for fairly long<br />
periods. Over the past several years, however,<br />
economic pressures on drug developers have<br />
grown <strong>and</strong> CRO are now seen as a key means to<br />
contain ever-exp<strong>and</strong>ing R&D costs <strong>and</strong> shorten<br />
time to market by virtue <strong>of</strong> their ability to achieve<br />
economies <strong>of</strong> scope <strong>and</strong> scale in the testing<br />
process. Therefore, an early adoption <strong>of</strong> leading<br />
edge technologies is one <strong>of</strong> the key enablers for<br />
delivering high quality services <strong>and</strong> the CROs<br />
should have a policy to protect themselves from<br />
technological obsolescence by duly validating<br />
all technologies deployed. Leveraging new<br />
technologies enable to reduce the cost <strong>of</strong> services<br />
<strong>and</strong> improve the effectiveness <strong>of</strong> the solutions /<br />
services <strong>of</strong>fered to its customers <strong>and</strong> to help<br />
business re-design/re-model its operational<br />
processes to take <strong>full</strong> advantage <strong>of</strong> the new<br />
technologies. The CRO must make sure that the<br />
data is protected <strong>and</strong> secured with a key principle.<br />
The aim <strong>of</strong> all CROs is to see that the objectives<br />
mentioned below are met:<br />
1. Seamless access <strong>of</strong> the applications at Data<br />
Center (DC) or Disaster Recovery Center<br />
(DRC)<br />
2. Improved infrastructure efficiency<br />
3. More stable environment<br />
4. Flexibility <strong>and</strong> ease <strong>of</strong> maintenance<br />
5. Improve the data quality <strong>and</strong> security<br />
Results <strong>and</strong> Discussion<br />
“Data are provided to people on a needto-know’<br />
basis”. The problems for the CRO<br />
under study with the existing obsolete<br />
infrastructure architecture are agility <strong>and</strong> gaining<br />
competitive advantage <strong>and</strong> therefore, an adaptive<br />
infrastructure solution is necessary to accelerate<br />
growth <strong>and</strong> to reduce costs. The solution<br />
proposed for the CRO under study on HP<br />
platform can address this problem by providing<br />
powerful servers, sophisticated storage systems,<br />
<strong>and</strong> flexible consulting <strong>and</strong> support services.<br />
There are a variety <strong>of</strong> factors that make<br />
the CRO business more challenging than before.<br />
Regulators around the world are increasingly<br />
asking for more detailed safety <strong>and</strong> security<br />
assessments not only <strong>of</strong> data in the data center<br />
but also on drug c<strong>and</strong>idates. Given below some<br />
<strong>of</strong> the challenges in CRO:<br />
Challenge: Improving performance, business<br />
continuity, data security <strong>and</strong> data integrity: To<br />
have a consolidated infrastructure model that can<br />
deliver applications to its disaster recovery (DR)<br />
<strong>and</strong> services to all its satellite centers while at<br />
the same time enabling VoIP <strong>and</strong> video<br />
Chavali et al