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Hot Topics > Patient safety

URMC forms group to help biotechs with translational research

03-Mar-2010 - URMC has set up the Center for Human Experimental Therapeutics (CHET) to help biotechs and academics advance product candidates from preclinical studies into trials in human.

WuXi collaborates with J&J to bring GLP to China

02-Mar-2010 - WuXi PharmaTech is collaborating with J&J Pharmaceutical R&D, providing the pharma with toxicology services and receiving training to establish GLP at its facility in Suzhou, China.

Trial sponsors and CROs must do more to recruit older people, says EU group

16-Feb-2010 - 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...

Arizona mulls exemption for preclinical animal testing

02-Feb-2010 - 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...

News in brief

Trial IRBs ERC and IRB to merge

11-Jan-2010 - 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).

WuXi partners to boost biomarkers

11-Jan-2010 - 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.

Lab Research develops first simultaneous cardiopulmonary monitor

07-Jan-2010 - Lab Research (LR) claims it is the first preclinical CRO laboratory to develop a cardiopulmonary monitoring telemetry system.

inVentiv builds REMS capacity with ParagonRx

06-Jan-2010 - inVentiv Health claims the acquisition of ParagonRx positions it as the leading supplier of REMS services in the pharmaceutical contract services sector.

Phase Forward appoints chief privacy officer

16-Dec-2009 - 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.

Bend makes enhanced HPMCAS DMF available

15-Dec-2009 - US formulation services provider Bend Research says a new safety file for the bioavailability enhancing drug excipient, HPMCAS, can now be referenced by its clients in FDA filings.

News in brief

Microsoft makes Amalga easier to access with Sentillion buy

15-Dec-2009 - US software giant Microsoft has unveiled plans to acquire Sentillion to further expand its presence in the clinical data management sector.

PRA hopes to manage PH I trials better with Quintiq software

10-Dec-2009 - 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.

RBM wins Roche schizophrenia bioassay contract

09-Dec-2009 - 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

09-Dec-2009 - 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...

Absorption Systems rolls-out preclinical device testing service

08-Dec-2009 - 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 wants biometric data for trials; may enable Phase I studies

07-Dec-2009 - 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.

MEP questions figure used to justify not having mandatory inspections of API plants

02-Dec-2009 - A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that...

QSI installs ERP system

30-Nov-2009 - Infosys Technologies has helped CRO Quantum Solutions India (QSI) implement Microsoft Dynamics NAV 2009 which will allow data management, process harmonisation and reduce delays.

IQWiG calls for EU trial disclosure laws, says Pfizer delayed report

30-Nov-2009 - 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.

Unilife files US patents for “world first” RTF vacc syringe; mulls Nasdaq listing

30-Nov-2009 - Unilife Medical Solutions has filed US patents for Unifill Select, which it claims is the first ready-to-fill (RTF) syringe specifically designed for vaccine delivery.

14 C "synth to clinic" simplifies development process, says Quotient CEO

24-Nov-2009 - UK contract services firm Quotient Bioresearch says its "Synthesis-to-clinic" service for 14 C labelled compounds can simplify early drug development.

Further boost for Covance’s biomarker offering in RBM deal

19-Nov-2009 - Covance will outsource biomarker activities to US laboratory group Rules-Based Medicine (RBM) in an exclusive deal announced yesterday.

Work needed to close gender knowledge gap

18-Nov-2009 - 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

17-Nov-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...

Catalent unveils ulta-sensitive melamine test for drugs

05-Nov-2009 - US contract services firm Catalent has launched a new test service capable of detecting trace amounts of the toxic chemical melamine in pharmaceuticals.

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