The Ultimate Strategy For clinical research organisations

A clinical research organization (CRO), also called a contract research organization is a

company that works in the pharmaceutical industry in most cases. The clinical research
organization may be inoled in all processes o! deeloping new pharmaceuticals. Others
merely administer tests on newly deeloped drugs.
"ome people also e#press concern about outsourcing to !acilities where the purity o! research
is $uestionable. There are numerous new clinical trials taking place in third world countries.
%hile these results must be duplicated in the &" in most cases prior to a drug gaining '(A
approal, $uestions about the methods employed and occasionally lack o! resources at a
clinical research organization continue to arise. This is not to suggest that there aren)t many
!ine CROs in many di!!erent parts o! the world.
Benefits of CROs
Contract research organisations (CROs) are typically perceied as supporting medical deice
companies only with product testing and alidation as part o! their c*#+ regulatory
re$uirements. ,n reality they can do much more, e#plains -ichael Creese o! "mithers Rapra.
'irst, it is important to understand what CROs are. -edical deice manu!acturers will
typically associate CROs with product testing, stability studies and clinical trials (hence
clinical research organisation and contract research organisation being used interchangeably
in these areas). Those !rom goernment background or non.medical backgrounds will
perceie CROs as research institutions that per!orm research sponsored by goernment and
based largely in academia. The reality is that a number o! CROs o!ten hae e#pertise in both
areas, and in addition hae specialist knowledge o! the uses o! materials and product design.
Market size and growth
A signi!icant portion o! R/( budgets are spent on outsourcing serices (domestic and0or
international) o!!ered by the CRO industry, appro#imately 123 billion in 4556. This !igure is
e#pected to grow at 237 oer the ne#t seen years and should increase !urther with the
broadening o! the spectrum o! serices outsourced to coer the entire alue chain.
%hat began as small specialized bouti$ue !irms o!!ering narrowly targeted outsourcing
serices to pharmaceutical clients hae come to dominate drug deelopment and clinical trial
management.
Clinical research associates help to organise and monitor the different phases of clinical
trials of drugs. Key responsibilities include
writng drug trial methodologies (procedures)
identfying and briefng appropriate trial investgators (clinicians)
setng up and disbanding trial study centres
designing trial materials and supplying study centres with sufcient quanttes
providing clinicians with instructons on how to conduct the trials
collectng and authentcatng data collecton forms (commonly known as case report forms)
monitoring progress throughout the duraton of the trial
writng reports
!ypical employers of clinical research associates
Pharmaceutcal companies
linical contract agencies or houses
!ospital academic departments
"ualifications and training re#uired
To become a CRA it is necessary to hold an undergraduate or postgraduate $uali!ication in
nursing, li!e sciences (!or e#ample, biology, microbiology, to#icology, biochemistry, or
pharmacology) or medical sciences (such as physiology, immunology, medicine, anatomy or
pharmacy). (oing a +h( may improe your promotional prospects (some employers proide
opportunities to gain higher pro!essional $uali!ications ia block or day release).
Key skills for clinical research associates
ommercial awareness
" logical and inquisitve mind
#ood organisatonal abilites
$%cellent numerical& wri'en and verbal communicaton skills
onfdence
'or -ore ,n!ormation about pharma !unctie +lease isit our website.