ClearTrial stresses cost benefits of trial management solutions
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.
Arizona mulls exemption for preclinical animal testing
Arizona moved a step closer to excluding federally regulated research facilities from animal cruelty laws yesterday after the Senate National Resources, Infrastructure and Public Debt Committee voted in favour of such a move.
OmniComm links TrialMaster EDC to MS HealthVault
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.
PPD sells biomarkers biz to Caprion
US CRO PPD has sold its biomarker discovery sciences unit to Caprion Proteomics, bucking the trend that has seen many of its sector rivals invest in this part of the contract research market.
MDS uses SAS to improve CRO-sponsor collaboration
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 launches SaaS data management system
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 selects Invivodata for ePRO
Quintiles Transnational has selected US ePRO solutions provider Invivodata to help it meet growing regulatory pressure to focus on the patient perspectives during trials.
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.
Deals and developments in the CRO sector
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.
Siro plans European growth; updates on Omega integration
Indian CRO Siro Clinpharm has renamed its European units and plans to open offices in two more countries in the region in the next few months.
Jubilant partners to expand GPCR screening services
Jubilant Biosys has entered into a co-marketing agreement with DiscoveRx, expanding the companies’ screening services and geographic reach.
SCDM publishes best practice clinical data “cleaning” guide
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.
Trial IRBs ERC and IRB to merge
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).
Florida Biologix expands bioreactor and fill capacity
A recently completed manufacturing and filling capacity expansion will help Florida Biologix meet deadlines and win repeat business according to company director Richard Snyder.
WuXi partners to boost biomarkers
WuXi AppTec is partnering with Qiagen to develop biomarkers, assay panels and personalised healthcare diagnostics and will use these, and existing technologies, to further clients’ projects.
PSI acquires Horiba imaging system
CRO Particle Sciences (PSI) is improving its formulation and characterisation abilities by acquiring a multimodal imaging system from Horiba.
MPI and Bioject form needle-free pact
US preclinical CRO MPI Research has formed an alliance with Oregon-based needle-free delivery specialist Bioject Medical Technologies.
inVentiv builds REMS capacity with ParagonRx
inVentiv Health claims the acquisition of ParagonRx positions it as the leading supplier of REMS services in the pharmaceutical contract services sector.
Equity group buys ZeeCRO’s bioanalytic unit
US investment group Kansas Venture Capital (KVC) has acquired ZeeCRO’s bioanalytical division.
Kendle opts for MetricStream for compliance management
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.
NexMed stays on Nasdaq after Bio-Quant buy
US drugmaker NexMed has maintained its place on the Nasdaq Stock Exchange, partly as a result of its acquisition of US preclinical CRO Bio-Quant.
Covance sets up in Seoul and Mumbai
US CRO Covance says its new development offices in South Korea and India will improve access to patients and reduce clinical development timelines.
Phase Forward appoints chief privacy officer
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.
Icon triples capacity at Dublin lab
CRO Icon says the expansion of its central lab facility in Dublin, Ireland will provide better support for its clinical investigators worldwide.
Deltagen adds to discovery offering with Benten buy
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.
TNO to move into Phase 0 studies with AMS buy
Netherlands-based contract research group TNO has purchased an accelerator mass spectrometer (AMS) to add microdosing to its clinical trial offering.
PRA hopes to manage PH I trials better with Quintiq software
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 launches FTA DMPK sample cards
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.
RBM wins Roche schizophrenia bioassay contract
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 launches Rave automatic SAE reporting add-on
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 partners to offer ePRO
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.
Absorption Systems rolls-out preclinical device testing service
Preclinical drug testing specialist Absorption Systems has branched out and opened a new surgical lab designed to help pharmaceutical firms assess the safety of biomaterials and medical devices.
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 to acquire Clinpharm
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 sets up central biostats platform
PPD is targeting growing demand for contract data analysis with a new biostatistics infrastructure that, it says, offers improved security and reporting.
Vetter’s first US plant brings it closer to customers
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.
IQWiG calls for EU trial disclosure laws, says Pfizer delayed report
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.
Synexus hails recruitment for vaccine trial
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.
Pfizer to build R&D capacity in China
Pfizer will expand its clinical services and biomedical presence in China as part of a worldwide effort to develop its R&D infrastructure.
UK contract services firm Quotient Bioresearch says its "Synthesis-to-clinic" service for 14 C labelled compounds can simplify early drug development.
Icon eyeing China
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.
MDS restructuring had little impact on early stage; VP
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.
Further boost for Covance’s biomarker offering in RBM deal
Covance will outsource biomarker activities to US laboratory group Rules-Based Medicine (RBM) in an exclusive deal announced yesterday.
PPD awarded $330m development contract with Janssen
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.
PharmaNet lands Scancell trial contract
US CRO PharmaNet will conduct early phase clinical trials of therapeutic cancer vaccines being developed by UK group Scancell under a contract announced yesterday.
eClinical definition is changing; SVP
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.
Work needed to close gender knowledge gap
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 plans for 35,000 sq ft site at hospital
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.
Pharma turning to SAAS
Pharma’s increasing collaboration and budget cuts have made hosted software more attractive to companies, according to Symyx which has made its lab notebook available on this platform.