Privacy changes could limit data for comparative effectiveness
Creation of large datasets for use in comparative effectiveness research and other fields could be limited by privacy modifications to the HITECH act, according to ACRO.
Gentronix deal boosts CRL’s genotoxicity service offering
Charles River Laboratories (CRL) is strengthening its genotoxicity screening service by offering Gentronix’s BlueScreen HC.
Active approach to assessing suicidality in trials needed; FDA
The FDA recommends clinical trial investigators actively query patients about occurrences of suicidal thoughts and behaviour.
IRB delays a frustration for investigators
Delays during IRB review are a growing concern in the trials sector according to Christine Grady of the US National Institutes of Health’s (NIH) department of Bioethics.
PPD forms North American Ph I network; looks globally
PPD has set up a North American Phase I clinical trials network to increase access to patients across a broader range of disease areas.
Top strategies for recruiting and retaining trial participants
Retention strategies, trial site evaluations and dedicated budgets should be used to recruit patients to, and keep them in, clinical trials, according to research.
FDA taking more cautious approach to non-inferiority trials
The FDA is taking a more conservative approach to data from non-inferiority trials when reviewing NDAs, according to a GAO report.
Almac says an effective biomarker strategy boosts a drug candidates’ chance of success and can ultimately add value to a developer’s business by opening door to diagnostics.
Paediatric trial globalisation raises scientific, ethical issues
Questions about the ethics and scientific validity of trials conducted under the Pediatric Exclusivity Provision have been raised after researchers found many studies used sites outside the US.
Spaulding completed Ph I pharmacology expansion
Spaulding Clinical has renovated its Phase I pharmacology unit, citing both sponsor and regulatory demand for centralized cardiac monitoring as drivers.
Latest deals and developments in the CRO space
Outsourcing-pharma presents a round-up of recent developments in the contract research sector, with news from Quintiles, Bioclinica and Cyprotex.
Quintiles and Theravance: telvancin trial followed proper procedures
Quintiles says it is confident that all proper procedures were followed during a 2006 study of Theravance’s antibiotic telvancin being audited by Indian drug regulators.
PPD and Microsoft to tackle REMS; Q2 Op income down on costs
PPD has teamed up with software giant Microsoft to help drugmakers meet REMS requirements more efficiently.
Gentronix raises funds to boost genotoxicity offering
Gentronix has raised funds to expand its portfolio of cell-based assays and strengthen its position in the European genotoxicity services market.
ACI iCommittees to support endpoint adjudication & DMC
Applied Clinical Intelligence (ACI) has launched iCommittees to provide a platform to support sponsors’ needs for clinical endpoint adjudication and data monitoring committees (DMC).
New York group aims to speed recruitment with e-records
A US group representing hospitals in New York wants to accelerate clinical research process by improving trial access to electronic patient records, while maintaining patient privacy.
Clinical trial technologies launched at DIA 2010
Outsourcing-Pharma presents a round up of the clinical trial technologies unveiled this week at DIA 2010 in Washington, DC, US.
PFC taps HMO database to run clinical trial simulations
CRO PFC Pharma Focus is using a HMO database to provide feasibility information before a clinical trial starts, reducing costs, risks and developmental timelines.
Increased focus on post-market safety and value has resulted in CROs handling more Phase IV work, according to a PharmaNet EVP, and this trend may continue as regulators seek real world evidence.
EMA urges cooperation to ensure ethics, GCP of trials
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.
EVPM speeds adverse event detection in some cases, study
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
Drug safety outsourcing varies among similar sized firms
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.
Biocon wins hospital “superbug” drug API contract
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.
IFMPA puts patients at heart of counterfeit drug fight
The IFMPA says that patients are the real victims of counterfeiters and has asked drugmakers to put this at the heart of their fight against fakers.
ERT buys CRS adding respiratory diagnostics to offering
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
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
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
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
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.
Metrics adds melamine testing
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
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”.
Biocius plans move to new HQ and business expansion
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
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
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
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 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.
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).
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.
Lab Research develops first simultaneous cardiopulmonary monitor
Lab Research (LR) claims it is the first preclinical CRO laboratory to develop a cardiopulmonary monitoring telemetry system.
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.
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.
Bend makes enhanced HPMCAS DMF available
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 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.
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.
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.
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 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.