Outsourcing-Pharma takes a look at how clinical research
organisations (CROs) operating in India can do their best to ensure
that clinical trials in the region are carried out ethically.
Outsourcing-Pharma focus: cutting the cost of clinical trials
After recent allegations in the media that poor and illiterate
patients in India are being used, often unknowingly, as human
guinea pigs to test new drugs for the pharma giants of the West,
Outsourcing-Pharma takes a look at how cutting...
Effective resource allocation and portfolio designs are vital to a
drug company's financial survival as backing the wrong product can
waste millions of dollars and vital development time.
Although clearing Parexel from contributing to the recent drug
trial disaster, a final UK Medicines and Healthcare products
Regulatory Agency (MHRA) report slammed the US firm for making a
number of basic errors during the trial process.
IT services company HCL Technologies continues to experience rapid
growth through its ability to undercut clinical research
organisations (CROs) on price for clinical data management (CDM)
services through its new operations in India.
US biotech company Spherix has selected Singapore-based clinical
research organisation (CRO) Gleneagles to take charge of the Phase
III clinical trial program for its new Type 2 diabetes drug,
Naturlose.
The World Health Organization (WHO) has announced details of a new
initiative compelling drug companies to register all clinical
trials on humans after public pressure for more transparency.
Kendle has seized a chance to expand and diversify its business,
snapping up the Phase II-IV Clinical Services unit of Charles River
Laboratories after it decided to get out of this area of clinical
trial services and focus instead...
The market for smart pharma packaging will grow to $1.7bn (€1.3bn)
in 2013 from the current $21m, driven by the need for new clinical
trial compliance-and brand protection measures, according to a new
forecast report.
Covance has stepped up its laboratory testing capabilities in the
Asia Pacific region to satisfy the growing number of sponsors
conducting clinical studies in this budding location.
As PRA International's profits tumble on the back of a major
contract loss, coupled with ongoing delays in its biotech
contracts, the company has introduced new project efficiency
measures and is focusing on increasing its international...
Parexel has expanded its regulatory and clinical development
services in the booming Latin American region, recently opening a
new location in Mexico City.
According to a new study, efforts to increase R&D pipeline
productivity have never been more aggressive, with clinical
outsourcing being one strategy employed by big pharma to lift
itself out of the doldrums.
PPD managed a 42 per cent jump in pre-tax profit to the tune of
$63.8m (€50.1m) in the first quarter, fuelled by a strong growth in
new clinical trials business and helped by a milestone payment in
the discovery sciences segment.
PRA International has bought its first company in India - contract
research organisation (CRO) Sterling Synergy Systems - joining the
growing list of top CROs who have set up operations in this fertile
market.
Outsourcing-Pharma focus on: Phase IIIB-IV research
The US Food & Drug Administration's (FDA) drive to clear the
mounting backlog of post-marketing (Phase IV) drug trials signals
good news for the clinical research organisations (CROs) who are
poised to benefit.
Covance has made a major expansion in its US Phase I/IIa drug
development capabilities, buying eight early-phase clinical
development sites from Radiant Research, who now plans to focus on
its Phase II-IV business.
Outsourcing-Pharma focus on: Phase IIIB-IV research
The US Food & Drug Administration (FDA) is investigating ways
of boosting the completion rate of new drug post marketing
commitment studies in the wake of ongoing controversy over the
agency's lack of enforcement. The answer,...
The number of new drug submissions has halved since 1995, while at
the same time, pharma companies are spending three times as much
money on R&D - a hole this industry needs to dig itself out of,
and fast.
A deal has been finalised making MDS Pharma Services the preferred
contract research organization (CRO) of the Multiple Myeloma
Research Consortium (MMRC) in the US, with further opportunities in
Europe to follow.
US-based contract research organisation The Smithers Group,
announced the acquisiton of UK company Rapra Technology in a deal
that seals the fate of Rapra, which was forced into Administration
last month.
A new interactive voice response (IVR) package is available for
small clinical trials, aimed at companies who previously found this
technology unaffordable.
The growth spurt continues for Icon Clinical Research as it opens
up a new office in Milan, Italy, following a recent acquisition and
two new global contracts.
Outsourcing-Pharma focus on: cutting the cost of clinical trials
As pharma companies flock towards Eastern Europe and India in a bid
to cut direct clinical trial costs, does outsourcing actually
translate into real world cost-savings?
Outsourcing company, Covalent Group, has announced the signing of a
$2.1M (€1.7M) contract to provide a range of services to support
the research and development of new therapies to treat
hyponatremia.
Rapid growth in the biopharmaceutical sector in China, India and
Southeast Asia has prompted US filtration specialist Pall to devote
more resources and industry experts to these regions, as the 14 per
cent growth seen in its BioPharm...
Kendle, who has been expanding its reach across the globe,
targeting the emerging Asia Pacific and Latin American markets, has
announced the acquisition of Latin American-based contract research
organisation, International Clinical...
Outsourcing-Pharma Focus: Cutting the cost of clinical trials
Patient recruitment consumes more time than any other clinical
trial activity, costing the industry millions of dollars. However,
recruiting patients on the Internet can slash recruitment times and
bring drugs to market faster.
The drug trial catastrophe, which has endangered the lives of six
male volunteers of which two are still in a coma, could've been
avoided after a similar study conducted last year yielded similar
side effects.
Parexel, one of the world's leading clinical research organisations
is under investigation after six men in a UK drug trial being run
by the company were admitted to intensive care on Tuesday.
Phoenix Data Systems has recently launched an interactive voice
response (IVR) system and a range of new services to accompany its
current electronic data capture (EDC) technology.
Datatrak's $18m (€15m) acquisition of ClickFind fulfills the
company's strategy of offering the broadest multi-component
eClinical capability in the clinical trials market.
Perceptive Informatics, a subsidiary of Parexel, has released the
latest version of its web interface for data capture, patient
randomisation and the management of study drug inventory for
clinical trials.
Anachem has just kicked off a unique new European-wide support and
maintenance service for scientific instruments - the first of its
kind - aimed to help instrumentation suppliers wanting to grow
their sales in Europe.
In order to stay competitive, Wyeth looks to model its business not
on that of other pharma companies, but of other successful big
industries, which includes outsourcing or off-shoring anything that
is not a core function.
Promed is due to start operations at its new research centre in
India, New Deli, this month, in a move that will bring the company
closer to becoming a global provider of drug development and supply
services.
According to a new report, the adoption of eClinical technologies
has been hampered by the ability to take the electronic revolution
to the next level, as the adoption of eClinical technologies
currently remain confined to localised...
Drug developer Biosante has been awarded a $250,000 (€210,000)
subcontract from the University of Nebraska, Lincoln (UNL), to
develop recombinant Factor IX (FIX) formulations for delivery via
alternative routes of administration,...
Chiltern is expanding its clinical trial services business in
India, and in doing so will be the first company to provide
specialised staff recruitment services for the Indian clinical
research industry.
Pharsight, a provider of software and strategic services for
clinical drug development, has seen its revenues dip for the second
quarter in a row due to lower-than-expected business from a top
client in its strategic consulting services...
British biotechnology firm Angel has won a manufacturing contract
from stem cell therapeutics expert ReNeuron Group to produce a
master cell bank for Huntington's disease, as the company's demand
for stem cells increases.
As China improves its resources and regulatory processes it will
soon become a hotbed of clinical drug research activity, and
position itself as one of the world's most important countries in
this field, according to a new report...
Outsourcing-Pharma: Focus on Phase IIIB-IV research
A new book is available to help those involved in designing and
conducting Phase IIIB and IV research gain maximum return on
investment and deal effectively with post-marketing safety issues.
The industry trend in outsourcing opportunities shows no sign of
weakening as contract researchers, easyRegDocs, introduced a new
service that aims to simplify the process of completing clinical
trial documentation, saving time and...
Outsourcing-Pharma: Focus on Phase IIIB-IV research
The spate of recent high-profile drug recalls, culminating in the
dramatic high profile withdrawal of Vioxx in 2004, has fuelled a
trend of consolidation within the Phase IIIB-IV clinical trials
outsourcing sector that looks set to...
Quest Diagnostics, the US's leading provider of diagnostic testing,
information and services announced better than expected fourth
quarter results after increased clinical testing activity helped to
offset a weakness in its test...
Outsourcing-Pharma: Focus on Phase IIIB-IV research
Phase IIIB-IV clinical research in the US is now booming, growing
20 per cent annually, compared with only 7 per cent for Phase
II-III research, driven by a surge in public drug safety concerns
and increased drug market competitiveness.
Japanese health care firm Eisai will make Hatfield its European
headquarters, in a major £75 million (€105 million) investment that
demonstrates the UK's appeal for big pharmaceutical companies.