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.
US drug discovery group Deltagen has acquired Benten BioServices, a contract services organisation that offers a suite of regulatory-compliant manufacturing and testing services to support biopharmaceutical development and commercialisation.
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.
GE Healthcare says its new range of sample collection cards reduce sample volumes needed for drug metabolism across pharmacokinetics (DMPK) in all stages of drug development process.
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.
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.
CMO Vetter Pharma has expanded its manufacturing capacity with a new in Illinois, US that it says brings it closer to customers and will allow it to collaborate with clients earlier in the drug development process.
World Courier has GxP compliant status for its whole distribution network, covering more than 140 offices in 50 countries, which it believes no other business in the sector has achieved on such a large scale.
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.
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.
Canada’s Biovail Contract Research says its stand-alone biostatistics unit will help sponsors “anticipate roadblocks ahead of time and create a sound statistical analysis plan for optimal results.”
Parexel has established The Expert Office to provide a single point of contact for clients which want the CRO’s team to assist them with optimising all aspects of the clinical trial process
Ohio, US-based CTI Clinical Trial and Consulting Services (CTI) has bought German trial staffing specialist CRS Clinical Research Services (CRS) to build its presence in Europe’s contract research sector.
Quintiles is continuing to build alliances with large pharmas, inking deals to perform “the majority” of AstraZeneca’s (AZ) clinical pharmacology work and develop six oncology products in Eisai’s pipeline.
MDS’ Central Labs has been rebranded as Clearstone Central Laboratories following its acquisition by Czura Thornton, which is looking to expand the business and that of Chiltern, a CRO also owned by the investment company, into new geographies, according...
In Q3 Phase Forward’s revenues from CROs grew by 44 per cent year-on-year and it predicts a bright 2010, as a backlog of delayed trials are started and big pharma attempts to cut IT costs.
Novotech says its new “management hub” in Kuala Lumpur, Malaysia will serve as a base for expansion in the booming Asia-Pacific contract research sector.
inVentiv Clinical Solutions' new Clinical Global Alliance will help meet industry demand for rapid access to “concentrated patient populations” according to CEO Michael Hlinak.
Quintiles is collaborating with Guy’s and St Thomas’ NHS Foundation Trust and King’s College London to establish a 30 bed Phase I site which will help meet demand for early-stage research conducted in patients.
Australia-based CROs, state government and a clinical trails network are collaborating with a Japanese company to encourage businesses to outsource preclinical and early-stage research to Queensland.
Globalisation and “heightened awareness and scrutiny of clinical trials” in the wake of the Northwick Park, UK incident, where some patients suffered multiple organ failure, have had a significant impact on study insurance, according to a MD.
The CRO results season is underway with Icon and Covance both posting mixed Q3 figures as the challenges facing pharma, and businesses in general, continue to impact on operations.
GEA Niro has begun offering contract spray-drying services for drug candidates and clinical trial supplies from its “Test Center” in Copenhagen, Denmark and wants the drug industry to know about the technique’s advantages.
Comparative effectiveness research (CER) represents a “historical market opportunity”, according to a VP at Quintiles who explained that pharmas that do the work will be “properly rewarded for their innovations”.
Health Decisions is “effectively franchising” its clinical trial model to other CROs to create a network of partners that it believes will offer “great flexibility” to clients, according to its COO.
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