Almac Clinical Services says novel temperature monitoring system speeds shipping and cuts quarantine times by allowing authorised personnel to make decisions on trial supplies at clinical sites 24/7.
Clinical trials are often biased against the recruitment of older people says the European Union's PREDICT group, which has launched a charter designed to protect such patients' right to take part.
The US Food and Drug Administration (FDA) has issued guidance on the use of Bayesian analysis in clinical trials of medical devices and says the technique can cut costs and boost efficiency.
Parexel has formed an alliance with Proteome Sciences to enhance its biomarker capabilities, allowing it to help clients make earlier assessments of new compounds in development.
Using intelligent compliance packaging in clinical trials can result in “huge cost savings” and this will ensure demand even during a period of cost-cutting, according to a sales manager at Stora Enso.
Consolidation in pharma, coupled to the trend for strategic partnerships, will lead to CRO mergers, with large companies getting bigger and small firms focusing on niche opportunities, according to a report.
SIRO Clinpharm has formed an alliance with South Korea-based CRO DreamCIS to expand its clinical trial offering in Asia Pacific and provide clients with more options for patient recruitment.
Integrated solutions are the future of trial data management according to Phase Forward as growth of the electronic data capture (EDC) market begins to slow.
BioClinica is providing Cephalon with end-to-end clinical data management services and hiring some of the biotech’s staff under a three-year, multi-million dollar deal.
Improving healthcare infrastructure across the region and a large treatment-naïve patient population makes the Middle East and North Africa (MENA) an increasingly attractive destination for drug trials says ClinTec CEO Rabinder Buttar.
Oracle Health Sciences has launched pharmacovigilance software Argus Safety Suite 5.1 to help pharma and CROs meet regulatory compliance and support safety processes from clinical development through post-marketing.
CRO Novella Clinical is providing OSI Pharmaceuticals with clinical research and related services over the next two years and will gain use of facilities in Boulder, Colorado, US as part of the deal.
ClearTrial says information is power in trial talks and claims its CTO software helped biotech firm save 20 per cent of bid cost through more informed negotiations with its CRO.
PRA International has entered into a partnership with Oncopartners and IBPC to accelerate the planning, start-up and patient recruitment of oncology trials in Latin America.
OmniComm has connected its TrialMaster EDC system to Microsoft (MS) HealthVault, allowing health records and data to be transferred to a patient’s file during clinical trials.
MDS Pharma Services has adopted SAS Drug Development to allow for closer collaboration with sponsors and provide a centralised, integrated system for data management and analysis.
Malgorzata Szerszeniewska, CEO of Central and Eastern Europe’s (CEE) “newest” CRO EastHorn, says maintaining ethical standards is crucial to sustaining the rapid patient recruitment rates that characterise the region.
Fujitsu has launched a SaaS-based data management system which it claims can speed up clinical trials, eliminate set up and maintenance costs and allow CROs and sponsors to use the same IT environment.
Quintiles Transnational has selected US ePRO solutions provider Invivodata to help it meet growing regulatory pressure to focus on the patient perspectives during trials.
Latin America, new services and mid-sized pharma clients are targets for the incoming CEO of Clearstone Central Laboratories, who set out his vision for the business in an interview with Outsourcing-Pharma.
Conducting trials in smaller patient populations when developing personalised medicines poses challenges, such as how to recruit patients fast enough, but these can be overcome using adaptive methods, according to a CEO.
The FDA has issued draft guidance detailing the information that should be submitted to an IRB as part of the continuing review of a clinical trial, with particular emphasis placed on the rise of multi-site studies.
Outsourcing-pharma presents a round up of all the latest deals and developments in the contract research space. This week Synexus closes ClinPharm deal, GVK joins ResearchPoint Global and CliniPace wins gNO contract.
The SCDM says that edit checks are a crucial component of achieving error-free data and has updated its Good Clinical Data Management Practices (GCDMP) resource with a best practice guide.
European ScreeningPort is using IDBS’ ActivityBase XE to manage growing demand for screening services from the academic institutes which outsource to it.
US clinical trial review groups Independent Review Consulting (IRC) and Ethical Review Committee (ERC) are to merge and operate under the name Ethical and Independent Review Services (E&I).
Piramal Healthcare is planning to raise Rs 10bn ($218m) over the next six to eight months to fund overseas acquisitions, with the India-based company eying several sectors including contract research.
The economic recovery will result in the resumption of delayed outsourcing deals and increased hiring but uncertainty remains and this could drive M&A, according to the IAOP which has listed 10 trends to watch in 2010.
US CRO Pacific Biometrics is to be renamed Pacific Biomarkers, after shareholders voted in favour of the change at the company’s AGM earlier this month.
Trials contractor Kendle International will use a management platform developed by US software group MetricStream to help control its global compliance and quality assurance operations.
US eClinical firm Phase Forward has created the new executive role, “chief privacy officer,” to ensure it complies with the latest data protection and privacy regulations governing the trial sector.
Clearstone Central Laboratories has appointed Lewis Cameron as CEO and he will now lead the company as it plots its development following divestiture from MDS Pharma Services.
PRA International has called on Netherlands-based software group Quintiq to help manage the Ph I research projects it takes on and better allocate resources in the challenging early-phase trial sector.
Swiss drug major Roche has called in biomarker testing lab Rules-Based Medicine (RBM) to help give its candidate schizophrenia drugs a commercial edge.
Medidata says the latest addition to its EDC platform, the Rave Safety Gateway, will cut the time it takes to report adverse events during trials and help CROs and their sponsors comply with increasingly stringent reporting rules.
Almac has entered into a partnership with FACIT.org to gain PRO and QoL assessments which it believes will help it recruit patients and generate high quality data for regulatory submissions.
Irish CRO Icon has received a US Food and Drug Administration (FDA) warning letter relating to two studies of an antibiotic it conducted between 2004 and 2006.
India’s Ministry of Health and Family Welfare (MHFW) want to make the collection biometric data from all clinical trial participants standard across the country’s research sector.
Synexus has agreed to acquire Clinpharm, giving it access to 10 clinical trial sites in Germany, Austria and Ukraine and increasing its patient population reach in Europe by 100 per cent.
PPD is targeting growing demand for contract data analysis with a new biostatistics infrastructure that, it says, offers improved security and reporting.
India-based CRO Ecron Acunova will support its geographic expansion and strengthen its service offering after receiving Series B financing from OrbiMed’s Caduceus Asia Mauritius.
IQWiG says Pfizer’s refusal to make some data available “hindered” its report on antidepressants and called for EU mandated trial registration and publication rules.
