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.
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 outsourcing industry, Parexel CFO Ingo Bank said Tuesday.
The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies.
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.
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.
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.
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.
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 bypasses sponsors and CROs.
The Raleigh, North Carolina-based CRO INC Research plans to raise about $150m in its initial public offering via about 8.1m shares at a price range of $17 to $20 per share.
Although a growing number of sponsors and CROs have managed strategic relationships for as many as five years, sponsors still rely on a mix of outsourcing approaches to tackle their clinical programs, according to a new report.
The Association of Clinical Research Organizations (ACRO) on Monday announced plans to create a CRO Forum in order to provide a formal mechanism for the CRO industry to offer insight into the work of industry group TransCelerate BioPharma.
Mid-size and large sponsors foresee increases in RFP (request for proposal) volume for outsourced clinical services across all phases through December 2014, especially for larger CROs, according to a new report.
Swiss-based Sellas Life Sciences Group has signed a definitive master service agreement with CRO Pharmaceutical Product Development (PPD) to advance and expand clinical and regulatory development.
Squeezed by the pressure of shorter deadlines and higher quality expectations, as well as by competition from larger peers, mid-size CROs may need to think more about innovation to stay ahead, a CEO of a mid-size CRO told us.
Little more than a week after purchasing the UK RTSM provider ClinIntel, Parexel has secured new office space in Nottingham, UK and won grants totalling £1m ($1.6m).
Following pushes to go public by top peers, CRO INC Research has filed an S-1 with the SEC in preparation for an IPO (initial public offering) on the NASDAQ.
CRO Parexel International has acquired all of the outstanding equity securities of privately-owned and UK-based ClinIntel, a provider of clinical Randomization and Trial Supply Management (RTSM) services.
Campaigning group Alltrials has reiterated its call for the EMA to prevent "excessive redaction" and to let researchers print clinical trial data without fear of litigation ahead of the Agency’s vote on its access policy later today.
China-based WuXi PharmaTech has acquired CRO XenoBiotic Laboratories (XBL) to bolster its bioanalytical and DMPK (Drug Metabolism and Pharmacokinetics)/ADME (absorption, distribution, metabolism, and excretion) services. Financial terms were not disclosed....
An ex RPS employee who claimed he was sacked after discovering the CRO was unlawfully storing potential employees’ personal data has settled his lawsuit and withdrawn allegations of wrongdoing.
In a sign of further industry consolidation, CRO Chiltern has acquired Pacific Clinical Research, a pan-Asian CRO based in Singapore. Financial terms of the deal were not announced.
CRO PPD has exercised its option to acquire the remaining minority ownership interest of X-Chem for an undisclosed sum. X-Chem will continue to operate as a small molecule discovery company with its entire existing staff and management team.
At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified electrocardiograms in all nine clinical trials evaluated.
The rarity of medical research reanalysis and the extent to which reanalysis changes the original findings has two physicians calling for more transparency in an editorial in this month’s JAMA (Journal of the American Medical Association).
Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical practice) inspection citing deficiencies in the...
More commentary on the US FDA’s informed consent draft guidance is trickling out, this time with ACRO (Association of Clinical Research Organizations) and the Dana Farber Cancer Institute offering their take on what should be included in the final guidance.
CRO Covance and Fresenius subsidiary Frenova Renal Research are collaborating to find more effective treatments for patients living with chronic kidney disease (CKD) and end stage renal disease (ESRD).
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 the revisions didn’t include.
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 in the Drug Information Association's Therapeutic...
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.
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 planned European Commission reshuffle.
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 waning interest.
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 needs of the companies.
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.
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 just in a short-lived rut.
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 go public with an IPO.
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, Quintiles CEO Tom Pike said Monday at the Morgan Stanley...
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
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’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.”
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 to its sequential parallel comparison...
