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Hot Topics > Patient safety

News in brief

ERT buys CRS adding respiratory diagnostics to offering

04-May-2010 - Cardiac monitoring and ePRO specialist ERT has added respiratory diagnostics and device manufacturing services to its offering with the acquisition of CareFusion Research Services (CRS) for $81m (€61m).

Datatrak adds Safety Export to eClinical suite

22-Apr-2010 - Datatrak has added Safety Export to its eClinical suite, reducing errors, shortening timelines and cutting costs by ending reliance on paper to exchange data between sites, sponsors and regulators.

CRL: China site gets GLP cert; new strain supply service launched

20-Apr-2010 - Charles River Laboratories’ (CRL) Shanghai preclinical test facility GLP certified by Belgian authorities under the OECD’s mutual acceptance of data framework.

Clinilabs adds ECG to offering with NewCardio deal

13-Apr-2010 - US CRO Clinilabs has licensed NewCardio’s QTinno cardiac safety analysis software, adding ECG services to it drug industry offering.

Aris launches integrated clinical trial software package

08-Apr-2010 - Aris Global has introduced Total Clinical 2.0, a software package which integrates EDC, safety and adverse event systems to streamline operations and cut costs.

Parexel adopts platform to handle post-approval trials

07-Apr-2010 - Parexel has implemented a web-based system to help it handle the increase in data volumes that has resulted from the expansion in number, size and complexity of post-approval studies.

Metrics adds melamine testing

31-Mar-2010 - Metrics is offering melamine detection testing services for starting materials to help clients ensure their products are free from contamination.

FDA drafts adaptive clinical trial design guidance

31-Mar-2010 - The FDA’s draft guidance on adaptive design in clinical trials is a balanced, practical publication, according to the EVP of a CRO who expects the document to generate a “robust...

Biocius plans move to new HQ and business expansion

30-Mar-2010 - US drug discovery technologies and services firm Biocius says its new HQ in Wakefield, Massachusetts doubles candidate testing capacity.

Ending trials early can cause misleading findings; study

25-Mar-2010 - Clinical trials that finish early due to positive treatment effects often have misleading findings, according to a journal paper which recommends researchers resist pressures to end studies prematurely.

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.

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