US contract research organisation (CRO) Parexel has cut its 2011 guidance, citing slower backlog conversion from projects generated by “strategic partnerships” as basis for the revision.
Big pharma outsourcing will become much bolder in the next 12-18 months as companies attempt to “dramatically attack cost structures”, according to the Covance CEO.
Contract Research Organisation (CRO) Quintiles has opened a Phase I facility in Hyderabad, India, citing increasing demand for efficiency in early-phase drug research in the country.
Oncology registries may be ineffective for recruiting large, representative samples of adolescent cancer survivors to clinical trials, according to research.
Ecron Acunova has expanded its Mangalore, India, clinical pharmacology unit to house 80 beds as demand rises from US and Canadian clients for pharmacokinetic and pharmacodynamic (PK/PD) studies.
The FDA has issued guidance on electronic data in clinical trials to help eliminate duplication, reduce transcription errors and promote real-time entry.
Merck plans to cash in on the biogenerics industry after forming a partnership with Parexel to develop copies of biologic drugs within its Merck BioVentures division.
PRO Consulting has expanded its range of Patient Reported Outcomes (PRO) offerings to better support drug and medical device developers using PROs in all stages of their clinical development programs.
Serious consideration was given to transferring MHRA clinical trial functions to the HRA after it faced criticism including reports of unprofessional and intimidating GCP inspections.
A report claims that extended clinical trial data exclusivity would benefit pharmaceutical innovation, leading to over 200 extra drug approvals and to greater life expectancy in future decades.
Creation of a “one-stop shop” for health research approval would free the UK from overly burdensome regulations that are stifling innovation, according to a report.
Pacific Biomarkers has established a scientific advisory board (SAB) to help it evaluate new technologies and opportunities in the clinical research sector.
CRO ReSearch Pharmaceutical Services (RPS) says acquisition buy private equity group Warburg Pincus will provide “financial strength” for future geographic expansion.
An agreement to provide exclusive toxicology services, pharmaceutical analysis and bioanalytical services are at the heart of a new partnership signed by life sciences company Bioanalytical Systems (BASi) and clinical-stage pharmaceutical company Pharmasset.
Biopharm is increasingly using the functional service provider (FSP) model, in areas such as medical affairs and statistical services, while continuing to globalise trials, according to Chiltern.
The contract service market failed to recover as hoped in 2010 and consequently many companies made cutbacks. Outsourcing-Pharma rounds up five of the most read of 2010.
Outsourcing-Pharma presents a round up five of our top articles on strategic partnering, which continued apace in 2010, including deals by Covance, PPD and Parexel.
Contract service providers continued to move into new geographies in search of more efficient R&D and production in 2010. Here we present five of our most popular articles on the topic, including Pfizer in Asia and the BRIC wall.
PharmaNet has launched its Initiator data capture and PKS analysis platforms in a bid to speed up data acquisition and processing of Phase I trial reports.
US CRO Dedicated Phase I (DPI) says plan to set up first in human (FIH) unit at Phoenix hospital reflects growing drug industry demand for studies in this setting.
PKPD modelling and simulation is now “ingrained” in drug development and its importance will continue to grow as approaches evolve in “very exciting” coming years, according to an Icon VP.
Russia is “becoming dependant” on foreign drugmakers according to Prime Minister Vladimir Putin, who has called for home-grown manufacturers to make more of the country’s medicines.
Understanding cultural and regulatory differences in BRIC countries could help multinational CROs move to the forefront of clinical development and compete with local CROs for drug trial contracts, say researchers.
Pfizer hired investigators to expose corrupt behaviour of the former Nigerian attorney general to ‘pressure’ him to drop legal action against the contentious Trovan drug trial, according to a leaked US embassy cable.
PRA has relocated its Poland-based early development services and product registration teams into a larger shared office after achieving “solid increases in the placement of clinical studies”.
The EMA inspects fewer than 1% of trial sites. Outsourcing-Pharma visualises this data and details the GCP-compliance sampling and collaboration strategies used by the EMA.
An urgent overhaul of ICH GCP is needed to “reverse the harm” caused by guidance that is bureaucratic, wastes resources and impedes scientific progress, according to a journal.
Outsourcing-Pharma presents an interactive visualisation of clinical trial data submitted to the EMA in MAA from 2005-09, showing the number of trials, sites and patients from each country.
Kerri Weingard, research director for Accumed, says the growing numbers of patients enrolling in multiple clinical trials are threatening the integrity of the clinical development process.
Finland, Brazil and Mexico recruit more patients per site than any other country where clinical trials are frequently conducted, according to EMA data.
New research suggests pharmas trialing drugs in BRIC countries are opting to work with smaller, home-grown contract research organisations (CROs) with local knowledge rather than multinational players.
The Christie cancer centre in Manchester, UK, has opened a £35m (€41m) early phase clinical trial unit to help develop new treatments for a range of cancers.