Contract Research Organisation (CRO) Calvert Labs has launched a new iPhone “app” that lets customers track the progress of preclinical research projects with their mobile phones.
Oncology registries may be ineffective for recruiting large, representative samples of adolescent cancer survivors to clinical trials, according to research.
US CMO Deltex Pharmaceuticals has been ordered to permanently halt manufacturing operations and recall all drugs it has distributed since October 2008, under a consent decree obtained by the FDA.
US CRO INC Research has bought industry consulting group Avos Life Sciences, citing pharma clients’ need to maximize return on R&D and minimize risk as the key driver.
The FDA has issued guidance on electronic data in clinical trials to help eliminate duplication, reduce transcription errors and promote real-time entry.
PRO Consulting has expanded its range of Patient Reported Outcomes (PRO) offerings to better support drug and medical device developers using PROs in all stages of their clinical development programs.
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.
Spectrum Pharmaceuticals and Viropro are to develop a biosimilar version of rituximab, a monoclonal antibody cancer treatment sold by Roche and Biogen Idec.
The US FDA has finally become a member of the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC/S) after a five-year application process.
Contract service providers continued to move into new geographies in search of more efficient R&D and production in 2010. Here we present five of our most popular articles on the topic, including Pfizer in Asia and the BRIC wall.
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.
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.
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.
India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures.
An academic clinical research centre that claims CROs markedly increase costs and reduce trial monitoring to box ticking, statements disputed by ACRO, has described its adoption of an in-house system.
The FDA significantly increased the number of concluded post-marketing requirements and commitments (PMR/PMC) in the 2009 fiscal year, according to a report.
WuXi has received GLP certification from the SFDA for its toxicology facility in Suzhou, China and, in a separate development, is providing CAS’ SciFinder to its staff.
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.
Parexel Consulting has released its annual analysis of FDA new drug review trends, which indicates there is a “new normal” emerging in the drug review and approval process.
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.
A strategic partnership between New England IRB (NEIRB) and Veritas IRB of Montreal will see their clients following a common protocol review for studies they conduct throughout the US and Canada.
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.
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.
Patient recruiters and national regulators must learn from each other to better understand outreach tactics and how they fit with a country’s ethics and laws.
Tracking “non-content” metadata is an important part of any pharmaceutical submission, yet many drugmakers fail to take an integrated approach to the task according to regulatory expert Kate Wilber.
Xcelience and IriSys have formed a joint venture to help streamline access to chemistry manufacturing and controls (CMC) and regulatory expertise for North American pharmaceutical and biotechnology companies.
ZRG Partners says there was a “fight for talent” in hiring, firing and vacancies in Q2, with the outsourcing and pharmaceutical sectors battling for employees within regulatory, quality and clinical roles.
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.
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...
