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Aravinda
Biosolutions is a
full-service Contract
Clinical Research
Organization. It caters
to pre-clinical and
clinical development
programs of the pharmaceutical,
biotechnology and
medical device industries
at a global level. |
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It
is mandated to provide
quality services in
the areas of project
management, clinical
operations, biometrics,
regulatory affairs,
document management,
quality assurance,
training, medical
writing, pharmacovigilance,
medical consultancy
and laboratory services. |
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Aravinda
Biosolutions offers
facilities and consultation
for drug storage,
inventory, temperature-controlled
transport and early
custom clearances
for clinical trial
supplies such as drugs,
vaccines, other biologicals,
devices, laboratory
kits, equipment, and
trial documents. These
services are also
compatible with the
use of centralized
randomization and
blinding techniques.
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The
supplies customs-cleared
and stored under customer-specified
conditions with complete
access control and
disaster management
and distribution is
traced up to the delivery
to site in accordance
with Aravinda Biosolutions
SOPs. Tertiary storage
areas designated for
drugs and biologicals
are maintained at
room temperature,
refrigerated and freezer
temperatures with
daily temperature
monitoring and back-up
generators. Aravinda
Biosolutions also
arranges for return
and/or destruction
of expired, unused
and damaged trial
supplies under customer-specified
conditions. |
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Aravinda
Biosolutions offers
secure off-site document
and electronic data
archival facilities
and consultation for
investigational sites.
These archival facilities
operate in accordance
with SOPs that ensure
complete access control
and disaster management
for business continuity.
A Records Management
Liaison Officer is
appointed for each
archival project and
is responsible for
understanding the
customer expectations,
managing the transfer
of documents to the
facility using the
agreed mode of transfer
and ensuring timely
and controlled retrieval.
Each batch of project
documents is bar-coded
and maintained under
stringent physical
and logical security,
temperature/ humidity
level maintenance
and environmental
hazard control until
such time as they
are returned to the
customer/ destroyed
as per Aravinda Biosolutions'
SOPs. The documents
that can be archived
include CAT scans/MRIs,
X-rays, ECGs and Case
Report Forms. |
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