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The FDA has issued draft guidance detailing the information that should be submitted to an IRB as part of the continuing review of a clinical trial, with particular emphasis placed on the rise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.
Infosys Technologies has helped CRO Quantum Solutions India (QSI) implement Microsoft Dynamics NAV 2009 which will allow data management, process harmonisation and reduce delays.
Synexus has recruited more than 2,000 children in three months for a Phase III rotavirus vaccine study, which it believes validates its methods and demonstrates they are particularly effective in late stage vaccine trials.
Icon is looking to expand its bioanalytical capacity in Asia, notably in China, and bolster its genomics, proteomics and cell-based assay capabilities, according to a VP who discussed diversification of the business.
The splitting up of MDS Pharma Services had little impact on the remaining business as there was limited integration anyway, according to a VP who detailed how the divestitures have allowed resources to be focused on core strengths.
PPD’s acquisition of Merck’s vaccine testing laboratory will give it a geographic location from which it can compete for business with its “number one competitor”, which is well established in the north east of the US.
PPD will work with J&J’s Belgian subsidiary, Janssen Pharmaceutica, on drugs for bowel, skin and lung diseases in a $330m in a deal announced yesterday.
US CRO PharmaNet will conduct early phase clinical trials of therapeutic cancer vaccines being developed by UK group Scancell under a contract announced yesterday.
Phase Forward is moving towards offering integrated systems to meet pharma’s need to maximise cost effectiveness and deal with upcoming EDC market saturation, according to a SVP at the company.
Regulators, industry and academia must do more to close the knowledge gap created by a historic shortage of women in clinical trials, according to speakers at AAPS 2009.
Icon is currently planning to occupy over a third of the 100,000 sq ft redeveloped hospital in Manchester, UK, which is due to open in 2012 and will become a flagship site for the CRO.
AAPS 2009 has drawn to a close but over the three days numerous trends and debates emerged, including the strategies CROs are using in the downturn, and we take a look at these in our conference round up.
