Pfizer, Merck, Eli Lilly and a number of other large pharmaceutical companies are calling on the FDA to supplement draft guidance on enrichment strategies for clinical trials with more examples from different therapeutic areas.
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 European CRO Federation is calling to widen the scope of a proposed delegated act related to pharmacovigilance legislation to include scenarios when observational PAES (post-authorisation efficacy studies) will be required.
Dispatches from Outsourcing in Clinical Trials East Coast, Philadelphia
Drugmakers Merck & Co and Eisai have both substantially cut internal data management costs through two unique off-shoring operations in China and India, respectively.
Pennsylvania-based Calvert Laboratories and Particle Sciences are combining their expertise in preclinical drug development to provide clients with more streamlined options.
India’s Ministry of Health & Family Welfare will create two new independent committees to oversee policy, guidelines and SOPs (standard operating procedures) for clinical trials, drug approvals and FDCs (fixed-dose combinations).
CROs and sponsors that apply a risk-based algorithm to monitoring clinical study sites could reduce the deployment of research associates and target more high-risk patients and sites, according to a new report from PricewaterhouseCoopers (PwC).
California-based CRO Agility Clinical and EU-based PSR Orphan Experts have partnered to allow orphan drug companies to utilize their safety and regulatory knowledge in both markets.
CRO WuXi PharmaTech has announced 22% net revenue growth in 2012 as its China-based lab services grew significantly. That trend is expected to continue with double-digit growth in 2013.
The US FDA’s ability to inspect facilities, trial sites, and deal with all but its most pressing priorities will be restricted by mandatory government spending cuts according to the Alliance for a Stronger FDA.
WuXi PharmaTech has expanded its partnership with Open Monoclonal Technology (OMT) to use its transgenic rats and mice in China and other Asian countries.
Welcome to Outsourcing-Pharma.com’s round-up of CRO focused partnerships and collaborations including news from Particle Science and Agility Clinical Partners.
Contract drug developer Particle Sciences has recently chosen China-based CRO Crystal Pharmatech to analyse the bioavailability and material properties of its developing compounds, and the collaboration may turn into a joint venture.
Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time in critical pre-IND/BLA meetings.
CRO Covance is teaming up with M2Gen’s cancer-focused database to increase its ability to match more patients in oncology trials based on their tumour profiles.
Ireland-based CRO Icon unveiled higher than expected revenue and backlog increases in 2012 when compared to 2011, and the company expects even stronger results in 2013.
In its second announcement of a closing research unit in little more than a week, Pfizer will axe its peptide therapeutic R&D unit CovX Research in San Diego, CA and lay off 100 employees there.
Quintiles painted a rosy picture of the CRO sector in its much anticipated IPO, predicting that biopharma R&D spending will increase and demand for outsourced research will grow.
Small biotech companies looking to crack into the increasingly lucrative Chinese pharma market need to outsource or partner with a local company in order to bring their products to market faster, experts said.
More flexible regulations on the path for approving potential Alzheimer's disease treatments represent a huge opportunity, according to the US FDA, CROs and research advocates.
CROs invest in scope and scale while private-equity groups buy firms they can expand according to Fairmount Partners’ managing director, Neal McCarthy.
A storm is brewing over the release of clinical trial data as GlaxoSmithKline on Tuesday took a step away from UK and US industry groups and said it intends to publish clinical study reports for all approved medicines dating back to when the company was...
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 publishing codes.
Icon has agreed to purchase the clinical trials services division of Cross Country Healthcare for $52m to primarily expand its staffing, pharmacovigilance and drug safety services.
Parexel may have raised its forecast for fiscal 2013 after reporting a 26% hike in second quarter revenues this week, but analysts still have concerns about its spending.
The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial sponsors or CROs.
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 says.
As vaccine production in India has hit manufacturing roadblocks over the past few years, GlaxoSmithKline (GSK) has signed a joint venture to begin development of a six-in-one pediatric vaccine.
Covance management sounded relatively upbeat about its expectations for 2013 as late-stage clinical trials continue to grow and IT spending begins to taper off, company officials said on Friday.
Despite conflicting media reports and confusion over where India stands in its regulation of clinical trials, Indian drug officials have until the end of January to respond to a Supreme Court order seeking answers on their alleged lax oversight of trials.
Following the release of FDA and EMA guidance in 2011 calling for CROs and trial sponsors to take a more risk-based approach to monitoring trials, companies have begun offering products to improve source data verification and more efficiently monitor their...
Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials by 2014.
