The EMA has published its thoughts on monitoring overseas trials and will seek to establish an international network of regulators to develop and implement a robust oversight framework.
The EMA’s EudraVigilance post-authorisation module (EVPM) speeds detection of adverse drug reactions in some cases, according to a new study published in the journal Drug Safety
More than 50 per cent of large pharma keep all pharmacovigilance in-house but among smaller firms, and even some big businesses, outsourcing is considerable, according to a new report.
Indian’s Biocon will supply US biopharma Optimer Pharmaceuticals with the API fidaxmicin for its candidate Clostridium difficile infection (CDI) drug OPT-80 under a new long-term contract.
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 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.
Charles River Laboratories’ (CRL) Shanghai preclinical test facility GLP certified by Belgian authorities under the OECD’s mutual acceptance of data framework.
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.
The FDA’s draft guidance on adaptive design in clinical trials is a balanced, practical publication, according to the EVP of a CRO who expects the document to generate a “robust discussion”.
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 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 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.
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 part.
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.
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 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.
inVentiv Health claims the acquisition of ParagonRx positions it as the leading supplier of REMS services in the pharmaceutical contract services sector.
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 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.
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.
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.
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 the numbers have been “dramatically misunderstood”.
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 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.
Infosys Technologies has helped CRO Quantum Solutions India (QSI) implement Microsoft Dynamics NAV 2009 which will allow data management, process harmonisation and reduce delays.
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.
US contract services firm Catalent has launched a new test service capable of detecting trace amounts of the toxic chemical melamine in pharmaceuticals.
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.
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”.
Swedish CDMO Recipharm’s International Environmental Award helps emphasize the drug industry’s wider role in society, according to company chairman Lars Backsell.
A spectrum of systems could eventually replace animal testing and provide a more ethical and economical route through preclinical, according to Kate Darley, business development manager at Kirkstall.
Quintiles and Cerner are combining their “unique sets of experience and expertise” to improve the efficiency of late phase research, the market for which exceeds $1bn (€677m), according to a SVP at the CRO.
US life science firm Sigma-Aldrich has received a Michael J Fox Foundation (MJFF) grant to create knockout-rat models of Parkinson’s disease (PD) to improve preclinical drug development.
The AAHRPP has issued a major revision of its standards, the first time it has done so, adding sections on transnational research and the separation of business interests from ethics review.
Clinical trials of cancer vaccines should enrol patients with no evidence of residual disease, according to FDA guidance, but this will increase development times compared to cytotoxic agents.
The Pan-African Clinical Trials Registry (PACTR) has become the first such database to be endorsed by the WHO, providing the world with access to studies on the continent and improving efficiencies.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.