Serious consideration was given to transferring MHRA clinical trial functions to the HRA after it faced criticism including reports of unprofessional and intimidating GCP inspections.
Creation of a “one-stop shop” for health research approval would free the UK from overly burdensome regulations that are stifling innovation, according to a report.
Demand for compliant, patient safe packs will help drive the global blister packaging market to a total value of $32.5bn by 2015, according to new research.
US CRO Dedicated Phase I (DPI) says plan to set up first in human (FIH) unit at Phoenix hospital reflects growing drug industry demand for studies in this setting.
Pfizer hired investigators to expose corrupt behaviour of the former Nigerian attorney general to ‘pressure’ him to drop legal action against the contentious Trovan drug trial, according to a leaked US embassy cable.
The EMA inspects fewer than 1% of trial sites. Outsourcing-Pharma visualises this data and details the GCP-compliance sampling and collaboration strategies used by the EMA.
The Partnership for Safe Medicines (PSM) has established a presence in India to bring together local stakeholders and protect consumers from counterfeit medicines.
An urgent overhaul of ICH GCP is needed to “reverse the harm” caused by guidance that is bureaucratic, wastes resources and impedes scientific progress, according to a journal.
The shift towards a complex global supply chain incorporating many suppliers and service providers is driving adoption of modern analytical methods to ensure quality.
Kerri Weingard, research director for Accumed, says the growing numbers of patients enrolling in multiple clinical trials are threatening the integrity of the clinical development process.
Production of BioDelivery Sciences International’s (BDSI) chronic pain treating drug, ONSOLIS, has resumed after a temporary voluntary shut down at contract manufacturers, Aveva Drug Delivery Systems.
Demand for drug discovery, development services and active pharmaceutical ingredients (APIs) were the main growth drivers in Q3 according to Wuxi Pharmatech.
Clinical trials in Latin America recruited 91 per cent more patients per site than studies conducted in the US from 2005 to 2009, according to EU MAA data.
Johnson & Johnson and Millennium Pharmaceuticals have recalled several thousand vials of the anti-cancer drug, Velcade following reports of white particles floating in the medicine.
Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures.
The FDA significantly increased the number of concluded post-marketing requirements and commitments (PMR/PMC) in the 2009 fiscal year, according to a report.
Inaccurate predictions based on animal models are the biggest cause of clinical failure according to Scottish CRO Biopta, which says use of human tissue samples for preclinical development would cut attrition rates.
Minipigs are a practical and flexible model for safety testing which probably provide better prediction of toxicity in humans than rats and dogs, according to EU funded research.
ACRO wants the US FDA’s overseas offices to play more of a role in monitoring clinical trials, and is calling for an additional $35m (€25.3m) to fund the work.
Indian CRAs need knowledge of ethics, clinical trial execution and general topics, such as the drug development process, according to a survey into training needs.
Revision to FDA guidance on adverse event reporting is a positive step and forms part of a welcome increased focus on safety, says the CEO of Prism Ideas.
Easily translatable and adaptable simplified clinical research ethic training guidelines have been created to support field workers in low-resource settings.
The US FDA’s risk evaluation mitigation strategy (REMS) can be a challenge for pharmaceutical companies unfamiliar with the process according to PPD’s executive director of risk management Frank Gallo.
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.