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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.

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...

Survey finds CROs far from going paperless with TMFs

30-Oct-2014 - Although the barriers for going paperless are relatively low for CROs, the service providers have yet to fully adopt electronic TMFs (trial master files), a new survey says.

Ukraine still attracting Quintiles, PPD, Icon, Parexel and INC says study

22-Sep-2014 - Political instability in Ukraine has not diminished international drug industry desire to conduct clinical trials there according to a new report.

Dispatches from ChemOutsourcing

CMO consolidation: Do biopharma partners see any benefits?

17-Sep-2014 - As contract manufacturers continue to consolidate , some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies. 

News focus

Public CROs are sign of booming market, not PE apathy say financial advisors

15-Sep-2014 - Experts have predicted more CROs will go public as Private Equity looks to get a return on its investments, but such shifts are indicative of a booming market rather than...

Mid-sized biopharma key to strategic partnerships, Quintiles CEO says

09-Sep-2014 - Strategic partnerships - always a hot-topic for CROs – are becoming almost exclusively a big issue for mid-sized biopharma, though small biopharma and large pharma companies are interested as well,...

PPD acquires RCT Logic’s license to clinical trial design tech

04-Sep-2014 - CRO Pharmaceutical Product Development (PPD) announced today that it has acquired for an undisclosed sum RCT Logic’s exclusive license from Massachusetts General Hospital (MGH) for the portfolio of patents related...

Quintiles sees strong demand from large pharma

04-Aug-2014 - Quintiles CEO Tom Pike told investors last week that the company is seeing “very strong demand from the larger pharmaceutical firms because their pipelines are full right now,” and at...

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