Lengthening supply chains increase the risk of patients becoming exposed to substandard or counterfeit materials in medicines, while pharmaceutical research in the post-genomic era is exposing patients to a swathe of new drug mechanisms. It is critical that patients exposed to developmental or marketed drugs are guaranteed ethical and transparent processes from industry, regulators and other healthcare organisations.
23-Nov-2011 - The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.
22-Sep-2011 - 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.
15-Sep-2011 - 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...
15-Sep-2011 - DaVita Clinical Research has opened a biorepository to help drug discovery teams develop personal medicines by understanding patient populations.
22-Aug-2011 - 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...
08-Aug-2011 - Systemedicus has developed informed consent and patient compliance apps for iPads and iPods and is looking to license the tools to CROs and sponsors.
18-Jul-2011 - Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.
05-Jul-2011 - Better designed protocols and early identification of risks can improve trial quality and help avoid warning letters, said the FDA.
19-May-2011 - Marketing applications should contain details of clinical trial ethics and be rejected if serious violations are found, said some EMA workshop participants.
16-May-2011 - 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.
16-May-2011 - Indian regulators plan to standardise clinical trial serious adverse event (SAE) reporting to ensure complete data is submitted.
19-Apr-2011 - Clinical trial sites must take a proactive approach to non-compliance by identifying risks and having corrective action plans, says a former FDA investigator.
18-Apr-2011 - The FDA is planning to change clinical investigator disqualification regulations following GAO recommendations.
12-Apr-2011 - Non-clinical CRO CIT has rolled out a new suite of drug candidate toxicity and safety assays that, it claims, can provide detailed data in just 14 days.
24-Mar-2011 - Aptiv Solutions and Cancer genetics have partnered to provide biopharmaceutical developers with support for cancer trials.
24-Mar-2011 - There should be a public debate on how the traditional clinical trial pathway can be modified to shorten time to market, says the AIFA.
22-Mar-2011 - The FDA has revised guidance on how its personnel conduct inspections of CROs and sponsors in light of technological advances.
22-Mar-2011 - Biomarkers are urgently needed to help fix the damaged Alzheimer's drug development pipeline and improve outcomes for patients, according to experts.
14-Mar-2011 - CRO and Pharma patient recruitment efforts can benefit from social networks and online patient groups, but clarification from the US FDA is still needed.
14-Mar-2011 - Training firm Clinical Research Site Training (CRST) has released the findings of a survey into the impact of increasingly complex clinical trials.
08-Mar-2011 - 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.
03-Mar-2011 - 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.
01-Mar-2011 - Contract packagers will lose deals if they fail to adapt to biopharm outsourcing “more and more” serialisation work, according to CEO of Covectra.
22-Feb-2011 - A shortage of investigators with knowledge of trial regulations and ethics is an obstacle to growth of Indian clinical research.
17-Feb-2011 - 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).