Regulatory professionals working for contract research organisations (CROs) in emerging markets could benefit from taking a test to bring them up to par with those in developed countries, according to RAPS.
Health economics and outcomes research teams must have a greater influence over clinical trial design if pharma firms are to achieve reimbursement goals, according to Cutting Edge Information.
The proposed changes to European clinical trial regulations accepted by the European Commission (EC) in July will put Europe on an equal playing field, according to Clinipace’s Andrea Schiefer.
The US FDA has revised its draft guidance on suicide risk in trials with updated terminology and expanded assessment criteria and has called for drug industry feedback.
Chinese CRO Wuxi Pharmatech posted impressive revenue growth for Q2 driven by demand for lab services, but the firm still faced margin pressure due partly to rising labour costs.
Icon has boosted its Phase I translational medicine services in Manchester, UK, in preparation for what it believes will be a boom in the drug development area.
India’s biostatistics outsourcing market is set to grow 15 per cent in two years thanks to a 50 per cent cost saving compared with the West, according to a new survey.
ResearchNurses.co will conduct home visits in clinical trials for three Big Pharma firms after forging an agreement with Nottingham University Hospitals Research and Innovation Department.
Inspectors will be able to visit clinical trial sites unannounced and seize records under new draft guidelines issued by the Indian Central Drugs Standard Control Organisation (CDSCO).
Access to patient populations is a bigger deciding factor than low cost when selecting a Phase I service provider, according to ISR’s new quality benchmarking report.
Parexel may be willing to act as a matchmaker for the small and midsized developers that work with its new BioPharm unit according to COO Mark Goldberg.
Proposed law changes put before the US Senate and the House of Representatives last week seek to eliminate duplicate trials and force sponsors to display all results on Clinical trials.gov website.
The US Patient-Centered Outcomes Research Institute (PCORI) has suggested the pharmaceutical industry is introducing bias into clinical trials through selective use of inclusion/exclusion criteria and comparators.
Parexel says EU trials directive never achieved harmonization aims and welcomes plans to simplify regulations, even if the implementation date is further away than expected.
The billion dollar Korea Drug Development Fund (KDDF) has called on US CRO Parexel to help local developers commercialise pharmaceuticals on the global market.
LabCorp moves closer to expanding central labs biz, Quintiles builds in Brazil, Synexus grows in South Africa and CRI opens new research facility - Welcome to Outsourcing-pharma.com’s round up of the latest news in the services space.
The EMA wants a debate on the extrapolation of clinical data to see if a framework is needed to govern this potential approach to reducing unnecessary research and letting industry use resources more efficiently.
Argentina’s clinical trial market will hit $76m (EUR60.4) by 2015 with growth driven by low costs, a good regulatory environment and large patient populations, according to a new study.
European laws on clinical trials need to be faster and more efficient but they are not the only reason for the decline in the sector according to EU health and consumer policy commissioner John Dalli.
A quarter of procedures carried out during clinical trials may be pointless according to a new study, which suggests that this unnecessary work costs around $5bn (€3.96bn) a year.
A new draft guidance stating the level of insurance cover required for trial participants in the UK will accelerate ethics committees’ approval process, according to experts.
It seems service quality really does mean bigger profits for CROs serving the pharma and biopharma industries, according to Industry Standard Research’s (ISR) new report.
