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Headlines > Clinical Development

Trial experts: ER doctors not always right about when to unblind

27-Nov-2014 - A specialist service can save clinical trials from being unblinded even in an emergency when patients’ doctors need to know their drug regimen.

Orphan drug CROs look to capitalize on influx of biotech cash

26-Nov-2014 - As small biotech companies continue to cash in on new investments, IPOs and increasing approval rates of orphan and rare disease drugs, CROs are cashing in too and helping the...

Analyst: Parexel book-to-bill worries will be short-lived

26-Nov-2014 - Last quarter’s disappointing book-to-bill ratio for Parexel, which sent the CRO’s shares down about 15% will be short term, according to an analyst.

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.

More details on Cetero/PRACS implosion come to light

24-Nov-2014 - Lachman Consultants has revealed more of the story behind the decline of the now bankrupt CRO Cetero/PRACS, which even though it’s shuttered, is still dealing with the fallout from its...

CROs mostly positive on proposed rule to make clinical trials more transparent

24-Nov-2014 - As part of a major transparency effort, the NIH (National Institutes of Health) and FDA are proposing to require the release of summary results of clinical trials for products that...

UK Hospitals to play part in Gov efforts to speed clinical trial process

20-Nov-2014 - UK life sciences minister George Freeman wants hospitals to play more of a role in clinical trials and says accelerating the drug development process in the post block-buster era is...

Analysis finds 100% SDV has minimal impact on overall data quality

20-Nov-2014 - An analysis of clinical trial data by Medidata and industry group TransCelerate BioPharma has found that the value of source document verification (SDV) in a risk-based approach to clinical trial site...

Dispatches from FT Global Pharmaceutical and Biotechnology conference, London

Quintiles CEO: Change in R&D paradigm must come from Pharma's boardrooms

19-Nov-2014 - Vertical integration is inhibiting pharma R&D innovation, according to Quintiles CEO Tom Pike who says executives must be involved in selecting CROs.

Questions raised over new $2.6bn price tag to bring a new drug to market

19-Nov-2014 - The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn,...

New Ricerca CEO remains positive as questions linger over company

19-Nov-2014 - As questions continue to be raised over why Ricerca was on the brink of closure and laying off all of its employees, as well as how the company’s new owners...

Collaboration can fix ‘broken’ clinical trials model TransCelerate CEO tells CROs

18-Nov-2014 - Collaboration does not mean drugmakers have started playing nice, it’s just that the pain of shared problems has become unbearable according to TransCelerate Biopharma CEO, Dalvir Gill.

Needles no more: say hello to a tube of squeezable biologics

18-Nov-2014 - Drug companies are looking for ways to put biologics in topical creams or “zap” them into skin using electricity as more large molecules come off patent.

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...

Trial transparency's impact opaque say drug and CRO industry experts at PCT in Barcelona

13-Nov-2014 - Making clinical trials more open has pros and cons for CROs and drugmakers according to experts from Amgen, Celgene, AstraZeneca, Icon and Lab Corp who spoke at an industry conference...

EU Ombudsman raises issues with some of EMA’s redactions of AbbVie data

13-Nov-2014 - The EMA said Wednesday it will formally respond to a letter sent by EU ombudsman Emily O'Reilly to the agency in which she took particular issue with some redacted information...

Parexel makes strategic moves in EU, South America

13-Nov-2014 - CRO Parexel is opening a new European Coordination Hub and Distribution Center in Berlin-Schönefeld, Germany, as well as new full-service clinical trial supply depots in Buenos Aires, Argentina, and São Paulo, Brazil....

Top 7 CROs soon to exceed 50% market share, Parexel CFO says

12-Nov-2014 - As PRA Health Services goes public this week, nearly all of the top CROs are now public and the top tier of these companies could control about half of the...

GVK BIO steps into GLP tox with Vanta Bioscience acquisition

10-Nov-2014 - Indian CRO GVK BIO announced the signing of a definitive agreement to acquire Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment CRO operating out of Chennai, India.

Exclusive interview

INC stock launches up almost 10% as CEO says business as usual

10-Nov-2014 - The IPO boom for CROs is kicking off with INC Research’s stock offering, which as of Friday afternoon saw a nearly 10% rise, meaning the company raised more than $150m.

China sets new requirements for hospitals running clinical trials

10-Nov-2014 - The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. 

Dispatches from Partnerships in Clinical Trials

Beautiful Horizon: Transparency and e-patients in Barcelona

05-Nov-2014 - Outsourcing-pharma.com is in Barcelona, Spain for Partnerships in Clinical Trials. Transparency and drug industry's (reluctant?) adoption of collaborative approach are hot topics.

Quintiles shines again in Q3 with IHS leading the way

03-Nov-2014 - Quintiles reported almost 14% growth in revenue, which was largely due to increasing revenue from its Integrated Health Services (IHS), which saw almost 35% quarterly growth.

Parexel stock falls about 15% as strategic partnerships slow down

30-Oct-2014 - Struggling strategic partnerships and lower conversion rates from its backlog have caused Parexel stock to bottom out slightly, though executives remain optimistic on the second half of this year.

Feature

Millionaire crowdfunding: the future of clinical trials?

29-Oct-2014 - A UK writer has described how his mission to start a trial for a therapeutic virus against his friend’s cancer has led to a new model of research funding which...