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Hot Topics > Clinical evolution

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Placebo response may be making pain trials tougher

02-Nov-2015 - It has been getting harder and harder for trial sponsors to show that drugs intended to treat neuropathic pain are effective - and the reason is surprising.

CROs engaging in a ‘war on talent’, Quintiles CEO says

30-Oct-2015 - The fight between CROs for clinical research associates (CRAs) and people with certain other skillsets is hotting up, with both Icon and Quintiles identifying it as an issue faced by...

Pressure group floats idea of government-backed clinical trial awareness campaign

29-Oct-2015 - The Coalition for Clinical Trials Awareness (CCTA) has called for a federally-supported public health campaign to make people more aware of drug research and the value of participating in studies. ...

Covance toxicology capacity use still suboptimal despite improvements

28-Oct-2015 - Covance has reported capacity use at its preclinical toxicology business is in the 70% range, meaning it is still well below optimal levels despite recent improvements.

Quintiles to access patient data for Phase IV studies through IMS Health deal

26-Oct-2015 - Quintiles has formed an alliance with information and technology provider IMS Health to access real-world drug data to be used in post-approval clinical research.

PRA acquires small clinical development software company for $2.5m

29-Jul-2015 - CRO (contract research organization) PRA Health Sciences reported in its earnings call on Tuesday that earlier in Q2 it acquired Value Health Solutions (VHS), a clinical development software company, for...

Indian government task force calls to simplify clinical trial approval process

28-Jul-2015 - As the number of approved clinical trials in India continues to taper off compared to years past, a government task force is now calling for a new expedited trial approval...

Eurofins not agnostic about diagnostics as evidenced by Emory investment

30-Jun-2015 - Eurofins has outlined plans to buy Emory Genetics Laboratory in the latest in a series of investments in the contract diagnostics sector.

Draft US House bill sets up a host of new clinical trial provisions

01-May-2015 - With the aim of getting new drugs to patients more quickly, a new House draft bill released Wednesday offers a whole set of new ideas around what the NIH and...

EBG BIOSIMILARS 2015

Regulators: skip clinical data and extrapolate biosimilar indications

29-Apr-2015 - Sponsors can license biosimilars for multiple indications without performing clinical studies for each area, the EMA and FDA agree.

Medidata chasing an ever-increasing slice of the $2bn EDC market

27-Apr-2015 - Medidata has reported its strongest ever quarter and says strategic CRO partnerships and risk-based monitoring offer opportunities to penetrate more of the market.

Pfizer reveals PPD as third strategic CRO partner

22-Apr-2015 - Pfizer has selected PPD as its third preferred contract research organisation (CRO), but the addition will not affect ongoing relationships with Parexel and Icon, the firm says.

'Unjustified' ban of GVK-tested drugs has damaged India, says Pharmexcil

08-Apr-2015 - The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.

Senators reintroduce bill to offer CROs a share of R&D tax credit

27-Feb-2015 - Sens. Tom Carper (D-Del.) and Pat Toomey (R-Penn.) reintroduced a bill that would permanently allow CROs (contract research organizations) to capture a share of the R&D tax credit. ...

US FDA working to make clinical trials less wasteful

16-Feb-2015 - The US FDA is looking to set up master protocols that can continuously run and help cut down on waste that’s prevalent in the clinical trial industry, Director of FDA's...

Exclusive interview

It's not the size... CRO Simbec-Orion on why it can compete with Quintiles

05-Feb-2015 - Being a drug developer not just a service provider differentiates Simbec-Orion from the Big CROs according to CEO Ronald Openshaw, whose firm signed two strategic partnerships last week.

CROs call for better ways to leverage investigative site relationships

03-Feb-2015 - Improving investigative site relationships in 2015 is a top priority for pharma and CRO (contract research organization) execs, according to a roundtable recently hosted by the Tufts Center for the...

Top CROs tight lipped about rumoured Pfizer deal

20-Jan-2015 - Quintiles has said Pfizer will “remain a customer” after analysts said the CRO lost out to a privately-owned contractor in the race to be the drug giant's third alliance partner.

CROs plan to increase use of ePRO tech

13-Jan-2015 - CROs, as well as sponsors, are receptive to, and plan to increase their use of ePRO (electronic patient reported outcomes), according to a survey published  Monday from the Tufts Center for the...

WIL IT software deal speed up US FDA drug evaluations? Yes says Instem

18-Dec-2014 - Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems.

CDSCO says Indian hospital charged for stem cell treatments given during unapproved trial

15-Dec-2014 - Indian regulators have accused a hospital of conducting unauthorised clinical trials of stem cell therapies and of charging patients who took part for the treatments.

Europe's response "disproportionate" says GVK Biosciences

15-Dec-2014 - GVK Biosciences has called marketing authorisation withdrawals by various European regulators “disproportionate,” arguing that ECG results at centre of data manipulation investigation have no bearing on safety.

INC Research expands partnership with Society for Clinical Research Sites

08-Dec-2014 - INC Research has expanded its partnership with the Society for Clinical Research Sites (SCRS) through the end of 2015 to become the first organization to support SCRS' new member Scholarship...

Medidata: Prepare to embrace digital biomarkers in trials or lose competitiveness

25-Nov-2014 - The advent of Big Data in clinical trials will mean companies not using digital biomarkers are unlikely to exist by 2025, the President of cloud-based technology firm Medidata has warned.

INFOGRAPHIC

PPD and inVentiv: Are the last privately-owned Big CROs ready to go public?

13-Nov-2014 - Soon PPD and inVentiv will be the only privately-owned top eight CROs, which prompted us to weigh up the firms in the event that either goes public in the near...

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