As electronic patient reported outcomes (ePRO) become more prevalent, the adoption of Bring Your Own Device in clinical trials “won’t be far behind,” says Bracket.
As more CROs look to divest in-house clinical trial technologies, Bioclinica has released a new Clinical Trial Management System (CTMS) sized specifically for smaller organizations.
India has 16% of the world’s population, 20% of the disease burden, and has contributed to less than 1.4% of global clinical trials, but the country is looking to fix this imbalance.
The global clinical trial management system (CTMS) market is expected to grow 14% over a five-year period hitting an almost $2bn valuation by 2019, according to a new market report.
A UK government report on accelerated access to medicines proposes overhauling conditional licensing and reimbursement pathways to drive drug development.
Australia’s National Health and Medical Research Council (NHMRC) is getting pragmatic with increasingly long clinical trial timelines and is now looking to streamline the research governance process in order to reduce delays in trial commencement.
Late last month the China Food and Drug Administration (CFDA) began mandating that drug registration applicants self-inspect and verify clinical data to ensure that it’s authentic and reliable.
The latest EMA (European Medicines Agency) report on GCP (good clinical practice) inspections reveals that deficiencies around SOPs (standard operating procedures), sponsor monitoring, data management, and essential documents linked to trials were most...
A number of small, mid-sized and large CROs (contract research organizations) and other companies tied to the world of clinical research have announced various partnerships and other financial moves over the past week. Here’s a roundup of the latest:
Waltham, Massachusetts-based CRO Parexel has launched three new academic programs in Germany, Japan and the US, designed to prepare students for careers in the biopharma industry.
Piramal has agreed to sell its clinical research business based in Hyderabad, India to Indoco Remedies which will add bio-equivalence and bio-analytical services to its offerings.
eSource solution provider Clinical Ink is merging with CentrosHealth, a provider of mobile apps for clinical trial patient engagement and electronic patient reported outcomes (ePRO).
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.
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...
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.
CRO (contract research organization) Parexel International has allowed clinical technology companies CRF Health and Clinical Ink to join its Perceptive Partner Program.
Cloud-based solution provider Medidata and CRO Icon have launched a joint initiative to bring new efficiency to the administration of electronic patient-reported outcomes (ePROs) in clinical trials.
WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, announced today it has acquired New England Independent Review Board (IRB).
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...
Bureaucracy is the biggest problem in accessing the Brazilian clinical research market, according to local CRO Techtrials, who says its expansion into the US was a far easier procedure.
The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than £284m ($475m) a year to support the delivery of clinical research studies, has reconfigured to become 15 local clinical research networks across England.
The need to improve efficiency and comply with regulatory and geographical demands is driving the third-party clinical payment industry, say Greenphire, CFS and Clinverse.
Plagued with tighter deadlines and calls for more efficiency, CROs (contract research organizations) seem to be increasingly turning to apps and cloud-based systems to develop CTMS (clinical trial management system) modules.
A Non-profit group focused on reshaping the clinical research will have started registering research sites as part of an effort to set up a global network.
The days of using Excel spreadsheets to manage clinical trial site payments are now in the past, especially as CROs and sponsors look to retain their most highly-prized sites and establish long-term relationships for future trials.
Ernst & Young (E&Y) analysts will try to illuminate the Sunshine Act for Greenphire's customers in the third collaboration the trial payment technology firm has signed in as many weeks.
Pfizer has chosen three of Synexus' clinical research centres in South Africa to be a part of its 100-site INSPIRE programme based on the sites’ experience and audit history.
An EMA report says increased Russian participation in European submitted clinical trials is part of a trend away from traditional regions, yet fluctuating legislation may affect numbers.
The PRACS Institute – the firm that emerged from the ashes of Cetero Research – has shut down operations at all locations according to local media reports.
The US FDA wants IRBs to remember it is their responsibility to check investigator qualifications, make sure sites are up to code and say if an IND is necessary for the proposed trial.
Outsourcing-pharma.com witnessed a fascinating debate on the definition of ‘CRO’ yesterday with terms like 'collaboration' and 'release' being suggested as potential alternatives.
The billion dollar Korea Drug Development Fund (KDDF) has called on US CRO Parexel to help local developers commercialise pharmaceuticals on the global market.
European laws on clinical trials need to be faster and more efficient but they are not the only reason for the decline in the sector according to EU health and consumer policy commissioner John Dalli.
