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Clinical evolution

Clinical evolution

Randomised clinical trials have been the mainstay of pharmaceutical product development for decades, but will they be designed and carried out the same way in future? With trials tipped to get smaller and patient selection more complex as pharma’s blockbuster model is dismantled, interactive technologies, adaptive designs and new ways to recruit and monitor patients will come to the fore.

PCT 2015

Strategic CRO relationships no more effective than traditional models, Tufts

25-Nov-2015 - Inconsistent practices and a lack of trust are restricting sponsors from fully realising the potential of CRO strategic partnerships, according to Tufts' Director Kenneth Getz.

Dispatches from PCT Europe

Apple and Google needed to make sense of growing clinical data mass, say experts

19-Nov-2015 - With data becoming growingly important in clinical trials, CROs and sponsors must embrace companies like Apple and Google to manage it, say panellists at PCT Europe.

CRO 'war on talent' could be ended through CRA simulation, says ex-monitor

16-Nov-2015 - A shortage of Clinical Research Associates (CRAs) is fuelling the “war on talent” among CROs according to an ex-monitor, who says a pre-hire simulation service can turn focus from retention...

Quintiles: Innovation and integration drives Apple ResearchKit input

13-Nov-2015 - Quintiles will provide its open source code to tech giant Apple’s ResearchKit framework to help create more efficient and integrated clinical trial apps.

Parexel expands late-phase service focus through Access division

10-Nov-2015 - Parexel has reorganised its Phase IIIb/IV offerings to cope with growing demand in market access and product lifecycle services from pharma firms.

Sponsor survey: Covance, Quintiles, PPD to dominate the CRO space

03-Nov-2015 - Covance, Quintiles and PPD are expected to lead the CRO space going forward according to a sponsor survey from the Life Science Strategy Group.

'Highest ever' cancellation rate impairs Parexel's Q1 FY16 results

02-Nov-2015 - Parexel has lowered its revenue guidance for the year following cancellations worth $305m in its first quarter FY2016.

News focus

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...


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.

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