Rexam and Med Time Technology, a US manufacturer of plastic prescription vials, have launched “Pill Timer,” a packaging solution designed to boost treatment compliance rates.
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.
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.
Retention strategies, trial site evaluations and dedicated budgets should be used to recruit patients to, and keep them in, clinical trials, according to research.
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.
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 Clinical has renovated its Phase I pharmacology unit, citing both sponsor and regulatory demand for centralized cardiac monitoring as drivers.
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.
Applied Clinical Intelligence (ACI) has launched iCommittees to provide a platform to support sponsors’ needs for clinical endpoint adjudication and data monitoring committees (DMC).
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.
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.
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”.
