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Headlines > Clinical Development

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.

TransCelerate hones in on two aspects of new risk-based monitoring methodology

22-Sep-2014 - TransCelerate’s new RBM (risk-based monitoring) methodology focuses on the use of technology and centralized monitoring to shift away from Source Data Verification (SDV) to risk-driven monitoring, according to two papers...

Concerns raised over FDA’s informed consent draft guidance

22-Sep-2014 - The US FDA was flooded with comments  on its draft guidance  seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what...

Evotec looks to recover payments from Andromeda over faked Phase III data

18-Sep-2014 - Evotec has taken legal action to recover €3.4m ($4.4m) in milestone payments from Andromeda Biotech which was found to have faked data in a Phase III trial.

update

Moving EMA to DG Enterprise will increase risk of adverse events says NGO

17-Sep-2014 - Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in...

Trial transparency: NICE stands firm on data

16-Sep-2014 - The UK’s NICE says it will go over drug companies’ heads and get clinical trial data from regulators if sponsors fail to supply their results.

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...

Quintiles continues seeking more small biopharma with new solution

15-Sep-2014 - Recognizing the critical role of emerging biopharma companies and their recent influx of cash , Quintiles has launched a new ‘emerging biopharma solution’ that aims to capitalize on the unique development...

More new rules for trial sponsors and CROs in India

15-Sep-2014 - Drugmakers sponsoring trials in India will need to weigh the potential risks and benefits for the people who take part under new guidelines issued by the CDSCO.

Update

Covance clinical issues normalize

11-Sep-2014 - Higher than normal cancellations for Covance’s clinical business have persisted now for a couple of quarters, though that downturn has since normalized and CEO Joe Herring believes the company was...

Web tool to match sponsors to trial sites in low-income countries

10-Sep-2014 - A free online tool could help trial sponsors with the “incredibly difficult” task of finding study sites in developing regions.

PRA Health Sciences evaluates IPO option again with SEC filing

10-Sep-2014 - A little more than a year after it was acquired by private equity company KKR (Kohlberg Kravis Roberts & Co.) for $1.4bn , newly rebranded PRA Health Sciences is looking to...

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,...

Biologics trials: the ‘stretched’ global supply chain

08-Sep-2014 - The high cost and complexity of producing biopharmaceuticals for clinical trials limits supplies and makes effective logistics even more important than for small molecule studies says Almac.

Investors losing interest in CROS? Have your say in our poll

Quintiles' investor day: Has Private Equity called time on the CRO sector?

08-Sep-2014 - An under-attended investor day at Quintiles, the world’s largest CRO, is indicative of waning interest in the clinical sector according to a William Blair analyst.

Pharma firms ‘saving billions’ in research – by giving away their tech

04-Sep-2014 - Pharma’s biggest players have donated more than $102m ($78m) of technology in a project to transform data sharing in clinical trials and “save the industry billions of dollars.”

More CROs expected to go public, Parexel CFO says

04-Sep-2014 - Parexel’s future course may depend on  the outlook of competing CROs (contract research organizations), a couple of which could potentially go public in the near future, Ingo Bank, SVP and...

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...

Update

Former Cetero researcher rebukes US FDA over warning letter

03-Sep-2014 - A former researcher of the now dissolved CRO Cetero Research told us the warning letter he received from US FDA was “contrived” because of the way the inspection was conducted.

Layoffs possible as Ricerca Biosciences in discussions to be acquired, CEO says

03-Sep-2014 - Ohio-based CRO (contract research organization) Ricerca Biosciences is holding “ongoing discussions with several parties” about the possible sale of one or more of its divisions or the entire company, CEO...

TransCelerate recommends what to protect in trial transparency efforts

03-Sep-2014 - Industry group TransCelerate Biopharma has developed a new recommended approach for protecting patients’ personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others as part of plans...

Synexus acquires fourth trial site in South Africa

01-Sep-2014 - CRO Synexus has expanded its presence in “the gateway to Africa” by acquiring the Helderberg Clinical Trials Centre (HCTC) in Capetown.

Clinical trials: the technology catching cheating volunteers

29-Aug-2014 - Contract research organisations (CROs) are turning to technology to fight dual patient enrolment in trials, but rival service companies refuse to sync their methods, says an early-phase expert.

Standardising trial measurements could stop ‘wasteful’ research

28-Aug-2014 - Regulators are showing interest in a database of clinical trial endpoints to cut redundant research, although contract research organisation Parexel has expressed reservations.

Volunteer drug users: the highs and lows of addiction trials

26-Aug-2014 - CROs must design their abuse liability studies to cope with volunteers who arrive under the influence or give misleading patient histories, says a specialist consultancy.

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