Most clinical trial sites are utterly unprepared in the face of a
natural disaster and are paying a heavy price if they are unlucky
enough to be affected, delegates heard at last week's Drug
Information Association (DIA) conference...
Indian contract research organisation (CRO) Synchron has acquired
local start-up CRO Innovance - a first-of-its-kind buyout in this
booming area of the pharma market.
INC Research has become the latest contract research organisation
(CRO) to dive into India, whilst Pharmaceutical Products
Development (PPD) has opened offices in Athens and Seattle.
Japan is getting serious about clinical trial reform after years of
lagging behind the rest of the developed world in the availability
of drugs in the country, which ironically is the world's number two
pharma market behind the...
Three doctors from a Russian hospital hired to run clinical trials
for GlaxoSmithKline (GSK) have now been charged by local
prosecutors over alleged illegal practices during the study on
children.
Medifacts International has sold its contract research organisation
(CRO) unit after a reorganisation sparked by the firm's filing for
Chapter 11 bankruptcy protection in February.
The FDA is giving contract research organisations (CROs) the chance
to take part in a pilot designed to test the viability of
electronic case report forms (eCRF).
The pan-European drug regulator, the European Medicines Agency
(EMEA), has adopted a draft guideline for first-in-man clinical
studies for potential high-risk drugs in a bid to prevent a repeat
of last year's TGN1412 drug trial...
PharmaNet has been told by the US Securities and Exchange
Commission (SEC) that it will now be the subject of a formal
investigation as it continues to be haunted by the early phase unit
it used to own in Miami.
The purchase of Canada's Allied Research International (ARI) has
given Cetero Research a boost to its early-phase clinical services
and geographic reach in Canada.
A potential new law mandating the running of clinical trials before
a "generic" biologic drug approval may seem like a potential
goldmine for contract research organisations (CROs), however, this
vision is premature.
Legal action could begin today against Parexel if the firm does not
come up with "an adequate proposal" to compensate the victims of
last years drug trial disaster in Northwick Park, London.
GlaxoSmithKline (GSK) has denied allegations that some of its
vaccines have been tested illegally and against good clinical
practice (GCP) in children in Russia.
PDL BioPharma, Synexus, Kendle, PharmaNet Development Group, MDS,
Chiltern International and Laureate Pharma have all had people on
the move in the world of pharmaceutical outsourcing.
India's budget finance minister has today announced a tax exemption
on all services carried out by its contract research and clinical
trials industry – a saving of 12.24 per cent.
The Ketek saga continues as a former employee of Pharmaceutical
Product Development (PPD) has claimed that Aventis and PPD – the
contract research organisation (CRO) hired by the firm – were both
aware of fraudulent data in a clinical...
US outsourcing company Covance has announced it is to open a
central laboratory in China in order to meet the growing demand for
clinical trials conducted in the region and has expanded its
capabilities in Texas.
Hesperion has opened a Russian arm of its contract research
business in a bid to 'increase its attractiveness' to clinical
trial sponsors requiring large patient populations.
Parexel has announced encouraging financial results for its second
fiscal quarter, despite 'disappointing' performance in its medical
communications business.
PRA International has entered into an alliance with US Oncology
Research, designed to accelerate the clinical development of new
cancer treatments in the US.
Charles River Laboratories confirmed it is persevering in its
intention to focus on its preclinical and Phase I businesses while
abandoning its late stage development services, during a conference
earlier this month.
The move towards electronic files is set to bring major benefits in
the clinical trials area especially in terms of patient
recruitment, new research suggests.
There are currently three key market trends that play to Parexel's
strengths and one of them is the globalisation of clinical trials,
the company's CEO claimed during a healthcare conference earlier
this month.
Covance was nothing but optimistic about the future of contract
research organisations (CROs) during a JPMorgan healthcare
conference held last week, despite a slowdown in R&D spending
over the past year.
Two companies have gone a step further to capture a bigger chunk of
the budding eClinical market by offering a new integrated solution
for pharma companies who continue to move away from paper toward
electronic reporting in clinical...
Quintiles has teamed up with practices group Onmark to create a
national clinical trial network comprised of Onmark members - a
move that could help the CRO cope with increasing patient
recruitment issues in the US.
China is now an industry buzzword when it comes to outsourcing and
yet another report adds to the list of research recently published
that give evidence of the increasing popularity of the country as a
location to conduct drug clinical...
A new clinical research tool is now available, offering
investigators the ability to integrate clinical data from a number
of different sources across the clinical development spectrum.
Singapore is planning to double the number of clinical trials it
runs over the next five year, particularly in early phase research,
as it looks to hold its ground amidst industry explosion in the
Asia Pacific.
MDS has announced it will help its customers confirm or repeat
analyses done at its contract research facilities in Quebec, after
the Food and Drug Administration (FDA) urged some drug makers to
retest products because of concerns...
The nature of patient compliance as the weak link in controlling
clinical trials is set to drive the growing interest of drug
developers and in particular contract research organisations (CROs)
for new technologies that improve compliance,...
Helix BioPharma and BioVectra have signed a deal for the
manufacture of Helix's new lung cancer drug for clinical trials - a
move that strengthens the already existing relationship between the
two Canadian firms.
Despite the many challenges facing the pharma industry, drug
developers should be optimistic, and one of the reasons is the
increasing reliance on global outsourcing to speed development and
reduce costs, says new report.
DSM Pharmaceuticals is showing no sign of slowing down as it
continues to invest in the expansion of its pharmaceutical
production capabilities - the latest being the completion of a
revamped sterile parenteral manufacturing plant...
Encorium Group has bagged a $12.4m multi-year contract from a
mystery biopharma firm to conduct a Phase III drug trial for
prostate cancer - the most common cancer in men.