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.
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.
04-Oct-2012 - Icon has forged an alliance with the South Korean Government in a bid to boost local trial activity.
02-Oct-2012 - Quintiles has forged a deal with the Scottish Government which it says will boost clinical trial activity in the country.
02-Oct-2012 - WorldCare Clinical has launched a blinded independent safety and efficacy review service to speed FDA approval of clinical trial data.
27-Sep-2012 - Open source drug developers could swipe business from CROs in the drug discovery field, according to Beroe.
19-Sep-2012 - Geriatric patients are left out of trials too often say experts who want researchers to 'open their minds' to the benefits of recruiting the elderly.
06-Sep-2012 - Improving efficiency in biopharma research is a “mixed blessing” for contract research organisations (CROs), according to Wells Fargo.
04-Sep-2012 - Automated drug accountability systems are becoming “the norm” in clinical trials because they can improve compliance and cut working time drastically, according to Cenduit.
23-Aug-2012 - Comprehend Systems recently made its data analytics, visualisations and reports software available from the cloud. CEO Rick Morrison spoke with Outsourcing-Pharma.com about the firm’s reasoning, and why no rockets were...