German CRO Evotec AG and Padlock Therapeutics have successfully completed an initial goal in developing inhibitors of protein-arginine deiminases (PADs) and have further extended their collaboration through March 2017.
The Board of Directors of the Association of Clinical Research Organizations (ACRO) has elected Jamie Macdonald, CEO of INC Research, as its 2015 chairman and David Simmons, Chairman and CEO of PPD, as vice chairman.
Sotio has selected local CRO Accord Research to carry out Phase I/II trials on its dendritic cell vaccines to treat patients with lung cancer in the Czech Republic.
India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill that would amend the country’s landmark law governing pharmaceuticals from 1940.
More than a year since its creation, India’s Apex Committee is now calling for developers of cancer treatments approved without trials in India to monitor the first 500 patients to assess the drugs’ safety and efficacy.
As the waiting period for LabCorp and Covance to proceed with their integration ended late last month, both companies are now turning to the logistics of the merger and hiring Deloitte consultants to help.
PPD and SNBL will set up a clinical services joint venture (JV) in Japan and collaborate on preclinical and Phase I bridging studies under a new agreement.
Contract drug developer Evotec AG has achieved multiple milestones resulting in €8m ($9.8m) in revenue thanks to its collaborations with Bayer and Janssen Pharmaceuticals.
With PRA and INC Research joining Parexel, Quintiles, Covance and Icon in the land of public companies, 2014 was a year in which the top shelf of CROs filled out.
PPD’s biotech company X-Chem has licensed a second drug discovery program to Bayer Pharma, which follows on a multi-target collaboration the companies established in 2012.
Cromos Pharma has launched a free or reduced cost trial model to help small and mid-sized drugmakers overcome the funding Catch-22 that can derail development efforts.
European CRO KCR has acquired a portfolio of clinical projects from the Ukrainian CRO Axis Group thereby making the country the most important location for KCR in the region of the Commonwealth of Independent States (CIS).
CROs are consolidating further, this time with DaVita HealthCare Partners’ business units DaVita Clinical Research (DCR) and HealthCare Partners Clinical Research merging to further expand their services, specifically for patients with chronic kidney...
CROs Pharmaceutical Product Development (PPD) and ERT on Tuesday announced a strategic partnership to deliver ERT’s patient safety and efficacy endpoint data collection tools to help biopharma clients conduct clinical trials in a more efficient and cost-effective...
Cancer Treatment Centers of America (CTCA) has selected the WIRB-Copernicus Group (WCG) to be its institutional review board (IRB) and thereby expand its clinical research program.
A Covance investor is raising questions over Goldman Sachs’ involvement in providing advice to the CRO’s board, which recently accepted a $6.1bn takeover offer from industry peer LabCorp.
Sweden is an expert in high-tech trials but stalls in the recruitment phase, says the academic trying to change all that with a database of biomarkers matching patients to studies.
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.
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.
Quintiles has been upgraded to stable by ratings agency Standard & Poor after a second stock offering and the consolidation of debt through a $300m securitisation facility.
R&D investment and an integrated platform are widening the divide between Medidata and its competitors, according to analysts who are confident the trial data firm can achieve target sales of $1bn.
A number of analysts recently initiated coverage on CRO PRA Health Sciences, with most predicting that the company’s recent IPO will result in a steadily growing stock price.
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 Program as well as the first CRO to establish a Site Advocacy...
The EMA may withdraw marketing authorisation for generic drugs trialled by GVK Biosciences next month, after German regulators suspended several products and launched a review of alleged data manipulation by the CRO.
Over the last three years US turnover in clinical monitoring has dropped from 29.4% to 16.4% and globally overall company turnover has dropped from 27.2% to 14.2% on average, according to the 16th annual CRO Industry Global Compensation and Turnover Survey.
CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials without compromising safety.
GlaxoSmithKline is significantly reducing the size of its R&D team in the US, though about 450 of those employees who will be laid off in the Research Triangle Park (RTP), North Carolina area will find new jobs with CRO Parexel.
Drugmakers including China in multi-regional trials would need to submit dossiers filed elsewhere for CFDA review, open up non-Chinese sites to inspections and conduct local studies under draft guidelines proposed by Beijing regulators.
Cancer drug developer CEL-SCI announced Tuesday that since dropping CRO inVentiv Clinical back in 2013, patient enrollment in the trial run by its two new CRO partners – Aptiv Solutions and Ergomed -- has increased more than eight fold.
Aid agencies in countries hardest hit by Ebola rely on manual, paper-based data collection according to one expert who says CDISC templates and mobile data capture would help.
The pace of recruitment is the biggest challenge in carrying out trials in Eastern Europe, says Mabion which has extended an agreement with local CRO Altiora for its biosimilar study.
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 companies navigate the regulatory and clinical landscape.
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.
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 are unapproved or unlicensed.
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 data integrity issues.
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 key for Big Pharma and patients.
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 monitoring is minimal.
Dispatches from FT Global Pharmaceutical and Biotechnology conference, London
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 and CEO plan to turn it around, one thing is certain: new CEO Clifford Croley is confident.
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, though some are saying that number seems inflated.
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.
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.
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 future.
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 in Spain last week.
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 from AbbVie’s CSRs (clinical study reports).
