A white paper that looks at the eClinical business model strategies
has concluded that larger investments and access to multicomponent,
single-source contracting options will create more efficient models
for businesses.
The US Food and Drug Administration (FDA) has announced the launch
of a new guidance to help drug makers evaluate lab test results
that fall outside the specification limits.
Pharmaceutical companies are beginning to catch up with other
industry sectors that take an increasingly realistic view of what
they consider a core competency and outsourcing what is left -
Outsourcing-Pharma takes a snapshot of...
Pharma companies that aren't maximising their outsourcing potential
in clinical research may be wasting a world of opportunity.
OutsourcingPharma.com gives a brief run down of exactly what kinds
of services and providers are...
As the Asia-Pacific continues to be a hotspot for clinical trials
activity, e-clinical provider ClinPhone has opened its first office
in the region in the hope of gaining a head start.
The Food and Drug Administration (FDA) is expected to issue a
revised version of its regulation on electronic signatures and
records by the end of the year, which will force drug and device
companies to reconsider their current information...
There is a growing realisation in pharma that, to remain
competitive, paper-based trials are not the way forward. Instead,
electronic data capture (EDC) and management technology solutions
are now readily available and becoming more...
Datatrak International said it has been offered a minimum of $3m
(€2.4m) worth of contracts for next year out of a deal struck with
its first "multibillion-dollar" pharma firm in the second quarter.
The need for better exploitation of clinical data is linked
directly to the general challenges facing drug development today as
development costs for new products have rocketed from $100m (€79m)
to $800m.
Most drug companies are not planning to increase the level of sales
and marketing IT they outsource over the next 3-5 years - a sign
that this niche segment may be bucking the wider pharmaceutical
industry outsourcing trend.
Contract Research Organisations (CRO) involved in clinical trial
services may benefit from a new technique that allows researchers
to statistically analyse results of clinical trials.
The European Union (EU) has been criticised for being more
favourable to big biotech companies, at the expense of smaller
firms, according to consultants within the industry.
Capgemini has received a new five year outsourcing contract to
provide IT services to ensure the smooth sailing of pharmaceutical
company Astellas US, newly-formed after a recent merger.
The clinical trials industry is struggling to cope with the burden
of maintaining adequate drug accountability documentation for
regulatory compliance.
PPD International has launched a new software system that it claims
can speed up the review time of safety and endpoint-driven data
from large-scale clinical trials or registries.
Spurred on by the frustration of drug manufacturers, governors from
four US states have petitioned the US Food and Drug Administration
(FDA) for clarity in their requirements for the production of
generic versions of insulin and human...
The use of eClinical software in clinical trials is gaining in
popularity with pharmaceutical, biotechnology and contract research
organizations (CROs), as seen by the recent financial results of
two major industry providers.
IBM has unveiled a radio frequency identification (RFID) system for
the tracking and tracing of pharmaceuticals, confident it will
accelerate the adoption of the technology by the drug industry.
Quintiles has turned its latest investment back towards home soil,
announcing plans to open a new US clinical data processing centre
in Williamston, North Carolina.
Are big pharma companies uninterested in supporting novel
formulations, preferring to stick to low-risk drug delivery
systems, or are they resourceful innovators that bring new
technologies to the market? Two pharma grandees holding...
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.
The pharmaceutical and life sciences industries are flushed with
quality IT services, with eight companies that have a specialist
life science/pharmaceutical focus being featured in the top 20 of
the first-ever listing of the world's...
European healthcare organisations are being driven to outsource
more and more IT operations due to escalating financial burdens,
increasing complexity of IT systems, and new government
initiatives.
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.
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.
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.
Medidata Solutions has opened a new clinical data centre and
enlisted the help of consultancy firm C3i to provide its customers
with faster and more secure electronic clinical trial support as
demand for these services continues to...
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.
To increase the chance of success in IT outsourcing, companies must
increase their focus on creating and managing a successful mixture
of supplier relationships that work for them.
As pharma companies tighten their belts, they are expecting more
and more cost savings from their outsourcing providers. IT services
company HCL Technologies spoke to Outsourcing-Pharma.com at
Interphex in New York to explain how...
Oracle has introduced a new software program to help pharma
companies integrate clinical data from multiple sources and
streamline regulatory compliance in the clinical development
process. Pharma giant Boehringer Ingelheim is the...
Medidata Solutions, a global provider of e-clinical data capture,
management and reporting solutions, benefited from the drive from
paper to electronic technology in clinical trials, picking up
several lucrative contracts and expanding...
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.
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...
DataLabs has launched the first software to combine paper data
entry (PDE) and electronic data capture (EDC) in the one program to
accelerate the clinical trials process.
Indian IT company Tata Consultancy Services (TCS) has scored a
contract from Danish pharma company Novo Nordisk for the data
management of its clinical trials run in India.
Leading contract research organisation, Covance, has upgraded its
software to streamline the laboratory testing aspect of its
clinical trials and allow sponsoring drug companies greater
involvement in the overall process.
Ventiv's Clinical Services division has joined with India's largest
domestic contract research organization (CRO), SIRO Clinpharm, to
provide India-based clinical data management services, offering
pharma and biotech companies...
In this new infographic, learn how Saama accelerates data review processes. Only Saama has AI/ML models trained for life sciences on over 300 million data...
It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...
