endpoint has introduced its new clinical supply management tool DRIVE, which enables interactive response technology (IRT) functionality for non-IRT and investigator-sponsored trials.
Brexit: Indian firms worried but Big Pharma and EMA remain positive for now
The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.
According to a recent survey, there are significant advantages to adopting eTMF – although some challenges still remain in the shift towards paperless clinical trials.
The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.
Researchers have developed a new magnetically controlled drug that can dissolve clots up to 4,000 times more efficiently than ordinary enzyme-based drugs.
India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.
Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.
The National Institutes of Health (NIH) has issued a policy on the use of a single Institutional Review Board (IRB) for multi-site research with the goal of streamlining the IRB review processes.
Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.
Frenova Renal Research has launched its inaugural group of site businesses which comprise F1RST Up – a program designed to accelerate study startup by eliminating common administrative and contracting issues.
The expansion is a “natural progression” for the British contract research organization (CRO) who has officially launched its US offering after a successful pilot.
The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.
Valeant will transfer production tech and modernise a controlled-release finished formulation facility as part of a $27.5m (€24m) investment in its Canadian manufacturing network.
The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.
The advent of low-cost, real-time technologies has made capturing real-world patient experiences easier than ever, allowing CROs to address concerns over end-use needs.
As a dedicated Chemical Biology Consortium center, AMRI will provide a variety of drug discovery services to help advance early stage drug discovery projects.
The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.
The global contract development and manufacturing organization (CDMO) announced that its Durham, North Carolina-based facility completed a successful US Food and Drug Administration (FDA) inspection.
Icon and Parexel recently announced renewals with pharma giant Pfizer, but according to analysts, PPD and an unknown fourth player may disrupt business as usual.
French authorities have started a manslaughter investigation in connection with a Ph I trial conducted by Rennes-based CRO Biotrial in which one volunteer died and five others were hospitalised.
