With data becoming growingly important in clinical trials, CROs and sponsors must embrace companies like Apple and Google to manage it, say panellists at PCT Europe.
A shortage of Clinical Research Associates (CRAs) is fuelling the “war on talent” among CROs according to an ex-monitor, who says a pre-hire simulation service can turn focus from retention to creation of staff.
Quintiles will provide its open source code to tech giant Apple’s ResearchKit framework to help create more efficient and integrated clinical trial apps.
It has been getting harder and harder for trial sponsors to show that drugs intended to treat neuropathic pain are effective - and the reason is surprising.
The fight between CROs for clinical research associates (CRAs) and people with certain other skillsets is hotting up, with both Icon and Quintiles identifying it as an issue faced by their businesses.
The Coalition for Clinical Trials Awareness (CCTA) has called for a federally-supported public health campaign to make people more aware of drug research and the value of participating in studies.
Covance has reported capacity use at its preclinical toxicology business is in the 70% range, meaning it is still well below optimal levels despite recent improvements.
Quintiles has formed an alliance with information and technology provider IMS Health to access real-world drug data to be used in post-approval clinical research.
CRO (contract research organization) PRA Health Sciences reported in its earnings call on Tuesday that earlier in Q2 it acquired Value Health Solutions (VHS), a clinical development software company, for $2.5m.
As the number of approved clinical trials in India continues to taper off compared to years past, a government task force is now calling for a new expedited trial approval process.
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 FDA can do to speed drug discovery and development.
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 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.
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.
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.
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 Center for Drug Evaluation and Research Janet Woodcock said in an interview.
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.
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 Study of Drug Development.
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, 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 Study of Drug Development.
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.
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.
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 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.
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.
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.
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.
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.
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...
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...
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 the same time, small biotech, with their plethora of funding, are starting...
Philanthropist Ted Stanley has gifted $650m to the Broad Institute as part of a wider attempt to galvanize research on psychiatric disorders and bring new treatments to market.
CRO inVentiv’s Clinical Trial Recruitment Solutions (iCTRS) and the non-profit Alliance for Clinical Research Excellence and Safety (ACRES) are partnering to accelerate the development of a global standards system to improve the conduct of clinical trials...
The Association of Clinical Research Organizations (ACRO) offered a number of recommendations to the US House Energy and Commerce Committee’s “21st Century Cures” initiative last week as part of an effort to keep the US research industry competitive globally.
Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.
Veeva Systems says its new global alignment solution for pharmaceutical companies will bring together data interactions and content into its Commercial Cloud.
Medpace Laboratories, Singapore will serve and support new and existing Medpace pharmaceutical clients conducting clinical research in the rapidly expanding Asia Pacific region.
Toxicology services provider Harlan Laboratories has selected Invenium Pharmacology as its exclusive agent for Harlan’s Contract Research Services (CRS) in Australia, Southeast Asia and New Zealand.
Biogen Idec’s five-year deal is the latest example of biopharma embracing the strategic partnership model, but the choice of Quintiles is somewhat of a surprise, according to ISI analyst Ross Muken.
Patient recruitment is “the major bottleneck” in clinical development, an Industry Standard Research report says, but though it predicts a drive to ‘push’ patients into trials, industry disagrees.
Genentech says its collaboration with PatientsLikeMe will enable more effective clinical trial recruitment but will not affect its partnerships with CROs.
CRO and sponsor payment service provider Clinverse announced a record first quarter to start 2014, with the addition of four significant new clients, as well as strong additional repeat business from existing clients.
Despite investor concerns about growth in R&D dollars for big pharma, CROs (contract research organizations) will benefit from the continued outsourcing, according to Citi analysts.
