According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.
The need for single-use bioprocessing sensors and probes are increasing as process monitoring and automation push their adoption.
In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis. By Malarkodi S. Moorthy, M.Sc., M.Phil., Medical Writer
At ICON, we have the expertise that spans the entire lifecycle of drug development. Our team of global safety experts is ideally positioned to design and implement comprehensive drug risk management programs and Phase IV safety surveillance programs.
Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
With our sophisticated full-service approach to post-marketing event handling (medical inquires, product quality complaints and adverse events), clients are assured that calls received from healthcare providers and / or patients and handled effectively and data obtained during a reported event are captured, stored and reported in a manner that not only ties all of the events together reported on a single call, but provides the best possible experience for the consumer.
Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.
ICON’s Medical and Safety Services Group offers safety support across all stages of the product lifecycle by providing efficient drug safety processes, compiling concise drug safety profiles, and developing tailored risk-management strategies.
