full issue - Association of Biotechnology and Pharmacy

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