31-Mar-2010 - The FDA’s draft guidance on adaptive design in clinical trials is a balanced, practical publication, according to the EVP of a CRO who expects the document to generate a “robust...
30-Mar-2010 - US drug discovery technologies and services firm Biocius says its new HQ in Wakefield, Massachusetts doubles candidate testing capacity.
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.
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.
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.
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...
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...
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).
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.
07-Jan-2010 - Lab Research (LR) claims it is the first preclinical CRO laboratory to develop a cardiopulmonary monitoring telemetry system.
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.
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.
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.
15-Dec-2009 - US software giant Microsoft has unveiled plans to acquire Sentillion to further expand its presence in the clinical data management sector.
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.
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.
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...
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.
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.
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...
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.
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.
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.
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.
19-Nov-2009 - Covance will outsource biomarker activities to US laboratory group Rules-Based Medicine (RBM) in an exclusive deal announced yesterday.