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.
Outsourcing-pharma presents a round-up of recent developments in the contract research sector, with news from Quintiles, Bioclinica and Cyprotex.
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.
PPD has teamed up with software giant Microsoft to help drugmakers meet REMS requirements more efficiently.
Gentronix has raised funds to expand its portfolio of cell-based assays and strengthen its position in the European genotoxicity services market.
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.
Outsourcing-Pharma presents a round up of the clinical trial technologies unveiled this week at DIA 2010 in Washington, DC, US.
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.