Creation of large datasets for use in comparative effectiveness research and other fields could be limited by privacy modifications to the HITECH act, according to ACRO.
Clinical data management is, and will continue to be a key concern for the pharmaceutical industry, according to Susan Bornstein, executive vice president of eClinical solutions, who discussed the issue with Outsourcing-pharma earlier this week.
Apricus Biosciences, formerly NexMed, announce preclinical data shows NexACT technology enables rectal delivery of biologics, including human antibodies.
Delays during IRB review are a growing concern in the trials sector according to Christine Grady of the US National Institutes of Health’s (NIH) department of Bioethics.
Patient recruiters and national regulators must learn from each other to better understand outreach tactics and how they fit with a country’s ethics and laws.
Retention strategies, trial site evaluations and dedicated budgets should be used to recruit patients to, and keep them in, clinical trials, according to research.
Aterovax has teamed up with Biomnis to target the clinical trial industry with a new atherosclerosis biomarker, sPLA2, designed to give researchers better insight into a candidate heart drug’s therapeutic potential.
Almac says an effective biomarker strategy boosts a drug candidates’ chance of success and can ultimately add value to a developer’s business by opening door to diagnostics.
The Asia Pacific trial sector grew during the global economic downturn as sponsors sought to improve access to patients, cut costs and improve data quality according to Novotech CEO Alek Safarian.
Questions about the ethics and scientific validity of trials conducted under the Pediatric Exclusivity Provision have been raised after researchers found many studies used sites outside the US.
The US Alzheimer’s Association has created ‘TrialMatch’, a free online tool enabling people with Alzheimer’s or related dementias to actively search for opportunities to enrol in clinical research trials.
Spaulding Clinical has renovated its Phase I pharmacology unit, citing both sponsor and regulatory demand for centralized cardiac monitoring as drivers.
Drug industry focus on clinical data quality, cost and speed is key driver for recent growth of Hungarian trials business says patient recruitment specialist Synexus.
Warnex says demand for contract analysis services increase in Q2 thanks to expansion in diagnostics market and forecasts growth opportunities in India.
Furiex posts Q2 loss as increased R&D spending and higher admin costs offset revenue gains, but firm is confident development model can boost partners’ pipelines.
Datatrak has posted an operating profit, grown revenues and recorded the forth consecutive quarter-on-quarter increase in backlog in its latest results.
Quintiles says it is confident that all proper procedures were followed during a 2006 study of Theravance’s antibiotic telvancin being audited by Indian drug regulators.
Ockham looks east for patient recruitment, setting up partnership with Russlan Clinical Research (RCR) to increase access to in-demand clinical trial destination.
Significant biopharm consolidation has played a key role in reshaping the drug development sector. Viq Pervaaz, senior vice president at Aon Consulting, discusses the changes and how they will impact on contract research organizations (CRO).
Icon reported a dip in operating income in the second quarter but an upturn in new business, and the cash to pursue M&A, make it reasonably positive about the future.
Japanese researchers look set to have another option for biomarker analysis, after Thermo Fisher Scientific unveils plans for Tokyo research laboratory unit.
CRO Quintiles says biomarkers give insight into cancer drug candidates’ efficacy earlier in the development process, reducing trial costs and duration.
Encorium has bought Progenitor International Research, furthering efforts to fix its financial woes by focusing on vaccines, oncology and growth in emerging markets.
