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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.

DAY 2

CRO world braves chilly Philly to attend CROWN Congress

27-Jan-2016 - The clinical trial industry has braved almost two feet of snow to attend this year's Clinical Research & Operations Worldwide Network (CROWN) Congress in Philadelphia. And Outsourcing-Pharma braved the cold...

Boehringer Ingelheim latest to switch trial-tech provider to Medidata

07-Jan-2016 - Medidata expects to become a strategic partner to even more pharma firms as Boehringer Ingelheim becomes the latest to transition to its cloud technology platform.

Will CROs adopt remote patient monitoring in 2016?

07-Jan-2016 - Experts agree that CROs will be more connected in 2016, however limitations – and hesitations – still surround remote based monitoring.

CTMS market set to hit $2bn by 2019 yet CROs may not be the driver

06-Jan-2016 - The global clinical trial management system (CTMS) market is expected to grow 14% over a five-year period hitting an almost $2bn valuation by 2019, according to a new market report.

The CRA is dead... long live the CRA! The evolving role of the trial monitor

10-Dec-2015 - Could the advent of technology herald the end of the clinical research associate (CRA) within five years? One industry expert believes so.

Should pharma stick to similar-sized CROs?

Little by little... does size matter in selecting a CRO partner?

30-Nov-2015 - Should small pharma firms stick to small CROs? Quintiles and Covance both believe they can offer the personal touch, but Outsourcing-Pharma wants to know what you think?

PCT Europe 2015

Big Pharma; Big bureaucracy; Big trial delays, says PCT panel

26-Nov-2015 - Big Pharma bureaucracy makes trials less efficient but listening to CRO partners can help reverse this, say experts from Pfizer, Bayer and  Grunenthal.

Correction

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...

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.

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