Quintiles has announced the opening of a new biostatistics unit
that it claims will help pharma firms cut the time and cost of drug
development through the "adaptive design" of clinical trials.
Avalon Pharmaceuticals and ChemDiv have revealed details on a
collaboration in which the two companies are to engage in drug
discovery in the oncology sector focusing on small molecules as a
basis for therapeutic development.
Outourcing-Pharma focus on: FDA clinical trial initiatives
The US Food and Drug Administration (FDA) has announced a series of
new policy and regulatory developments to modernise the way it
monitors clinical trials and bioresearch.
The US Food and Drug Administration (FDA) has outlined a series of
imminent changes to the way it evaluates clinical trials in an
attempt to clamp down on fraud.
Outourcing-Pharma focus on: FDA clinical trial initiatives
The US Food and Drug Administration (FDA) has signalled it will
soon allow a new "adaptive" approach to clinical trials in order to
streamline drug testing and speed drugs to market.
The Japanese pharmaceutical industry is eyeing India as a new hub
to conduct its contract manufacturing and clinical trials - India
is thirsty for new Japanese investment.
Despite looming threats from cheap Asian competitors, European
contract research organisations (CROs) still have a fighting chance
in the global R&D outsourcing market, according to a report by
research analysts Frost & Sullivan.
Archemix has announced the formation of a strategic alliance with
Elan to discover and develop first-in-class aptamer therapeutics to
treat autoimmune disease.
Parexel has linked arms with Synchron to cement itself in India for
the first time - joining the growing number of contract research
organisations (CRO) that are being lured to the region through the
promise of cost savings.
PRA International has been busy implementing an advanced data
management system as part of a number of new internal measures
aimed at improving operating efficiency and cutting the costs of
clinical trials.
Covalent Group has won several new clinical trial contracts to the
tune of $2.1m (€1.7m) and said it expects the windfall to help it
return to profitability for the second quarter.
As clinical trial activity in the Asia Pacific region continues to
boom, Novotech, the largest Australian owned contract research
organisation (CRO) has presented a checklist to help pharma firms
minimise risk when choosing a partner.
Data management solutions provider Phase Forward used the recent
Drug Information Association (DIA) to unveil a new programme
tailored to help clinical research organizations (CROs) of all
sizes optimise their eClinical profitability.
A new Phase I clinical services company, Roanoke Clinical Research
(RCR), has been formed to relieve pressure in the biopharma
industry as it continues to face bottlenecks in early stage
research and struggles to move forward fast...
Two French clinical research organisations (CROs), PharmaScan and
ClinicalLand, have joined forces to accelerate their growth and
reinforce their presence in the competitive clinical trials sector.
The world's largest patient recruitment firm, Synexus Clinical
Research has bagged its first Hungarian company in a bid to exploit
the growing clinical trial opportunities in the emerging Eastern
European market.
Top international clinical research organisation (CRO) Quintiles is
celebrating after winning two industry awards for its work in the
Asia Pacific region.
Schering-Plough has announced plans to adopt a new global model to
standardise its clinical trial operations throughout the world -
aimed at improving trial consistencies, efficiencies and saving
money.
ClinPhone has launched the first electronic solution for clinical
trials that enables central management of drug accountability
across the entire clinical supply chain, from distribution to
destruction.
World-leading clinical research organisation (CRO) Covance has
scored what it says is the biggest contract in its history - a
dedicated space agreement worth a minimum of $187m (€149m).
Outsourcing-Pharma.com focus on: cutting the cost of clinical trials
Outsourcing-Pharma.com sheds some light on how pharma companies can
make sure they are choosing a contract research organisations (CRO)
that will stick to the rules of ethics when running clinical trials
in poorly-regulated countries...
eClinical software and services firm etrials has launched the
latest version of its eDiary technology, which the company claims
will lead to cost savings and increased efficiency in the clinical
trial process.
Outsourcing-Pharma.com focus on: cutting the cost of clinical trials
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.