A new draft guidance stating the level of insurance cover required for trial participants in the UK will accelerate ethics committees’ approval process, according to experts.
Regulation of clinical trials in emerging markets is now too strict and is prompting sponsors and CROs to adopt “one-size-fits-all” designs, according to a new study.
Quanticate says it will eliminate unnecessarily “complicated spreadsheets” in clinical trial data analysis after integrating a new simplified web-based program into its own.
US pharmaceutical firm Eli Lilly says taking language, cultural diversity and site location into account helped boost ethnic minority participation in a recently completed trial.
Drug Developers struggle to find PK-PD providers that are fast and efficient says US CRO ClinPharm Consulting, after launching a new suite of services designed to cut risk and maximize return on R&D investment.
The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized drugmakers and Big Pharmas alike.
Marketing applications should contain details of clinical trial ethics and be rejected if serious violations are found, said some EMA workshop participants.
Indian CRO GVK Biosciences has been named as a preferred provider by a consortium, Product Development Partners (PDP), which is focused on drugs for neglected diseases.
Clinical trial sites must take a proactive approach to non-compliance by identifying risks and having corrective action plans, says a former FDA investigator.
CRO and Pharma patient recruitment efforts can benefit from social networks and online patient groups, but clarification from the US FDA is still needed.
Thermo Fisher Scientific has launched a predictive assay that, it claims, can assess a drug candidate’s potential to cause liver damage earlier than traditional methods.
US CRO Celerion is to expand in-house compounding for microtracer studies after gaining certification for cleanroom and pharmacists at its Ph I unit in Lincoln, Nebraska.
Passwords used to protect personal health information in Canadian clinical trials are often too easy to crack, according to a report in the Journal of Medical Internet Research (JMIR).
A global compulsory register of all contractors and subcontractors involved in each clinical trial should be created to increase transparency, according to a study.
US CRO the Duke Clinical Research Institute (DCRI) has teamed up with Kaplan EduNeering to develop a training programme to meet rising global demand for qualified clinical researchers.
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.
