Randomised clinical trials have been the mainstay of pharmaceutical product development for decades, but will they be designed and carried out the same way in future? With trials tipped to get smaller and patient selection more complex as pharma’s blockbuster model is dismantled, interactive technologies, adaptive designs and new ways to recruit and monitor patients will come to the fore.
01-Jul-2013 - Sponsors are piling on more responsibilities for their CRO partners, but the question of how that will translate into increases in risk and profit sharing is a point of contention.
26-Jun-2013 - With small companies and biotechs increasingly discovering new products, there are big opportunities for contract development and manufacturing organisations (CDMO), says ex-GSK expert.
24-Jun-2013 - Researchers behind a new automated adverse drug event monitoring method say it could act as an early warning system and guide Phase IV trials.
15-May-2013 - PRA International says technology and IT innovation will help it compete with rivals that have moved their service centres to cheaper locations in the East to cut costs.
16-Apr-2013 - Eisai has tasked a new exec with making trials more likely to succeed just a few months after its candidate ovarian cancer blockbuster failed at Phase III.
06-Mar-2013 - Welcome to Outsourcing-Pharma.com’s round-up of CRO focused partnerships and collaborations including news from Particle Science and Agility Clinical Partners.
06-Feb-2013 - CROs invest in scope and scale while private-equity groups buy firms they can expand according to Fairmount Partners’ managing director, Neal McCarthy.
05-Feb-2013 - Clinical trials made public by Pfizer did not match internal reports or reflect what was done in studies of the seizure drug gabapentin say researchers calling for revision of journal...
31-Jan-2013 - Bioclinica has agreed to a takeover by JLL Partners in a deal that would see the eClinical provider merge with medical imaging firm CoreLab Partners.
30-Jan-2013 - The US Food and Drug Administration (FDA) has adopted a practical Q&A from the International Conference on Harmonisation (ICH) to help sponsors and CROs craft clinical study reports (CSRs), an expert...
16-Jan-2013 - Variation in site recruitment performance is a major risk factor for CROs and their sponsors according to new research.
15-Jan-2013 - Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols.
10-Jan-2013 - Icon claims its collaboration with electronic Health record (EHR) specialist Cerner will help drug and device makers streamline data collection.
03-Jan-2013 - Parexel has acquired niche regulatory information management software firm Liquent and raised its guidance for 2013.
27-Nov-2012 - Pfizer is re-jigging its failed virtual trial model and could re-launch the programme as soon as 2013.
27-Nov-2012 - The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.
26-Nov-2012 - Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.
21-Nov-2012 - High CRA turnover in China often hinders trials, according to an Oxford University expert.
12-Nov-2012 - Molecular Partners has contracted Boehringer Ingelheim to produce a range of highly potent molecules for its clinical pipeline.
12-Nov-2012 - Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.
08-Nov-2012 - Risk-based site monitoring is easier under strategic partnerships than other relationship models according to Covance.
08-Nov-2012 - Outsourcing-Pharma.com is in Hamburg,Germany this week to meet the CROs, sponsors and academics gathered at PCT Europe to discuss the future of partnerships in clinical trials.
07-Nov-2012 - The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.
18-Oct-2012 - Catalent has established a new institute in a bid to advance drug delivery by creating links between industry and academia.
10-Oct-2012 - The pharma industry does not include children in clinical research for fear of mentally scarring them, according to ResearchNurses.co.