Clinical data management is, and will continue to be a key concern for the pharmaceutical industry, according to Susan Bornstein, executive vice president of eClinical solutions, who discussed the issue with Outsourcing-pharma earlier this week.
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.
Biomarkers are critical to discovery and can help pharmaceutical firms make development a more efficient and cost effective process accord to bioanalysis services provider KCAS.
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.
The Asia Pacific trial sector grew during the global economic downturn as sponsors sought to improve access to patients, cut costs and improve data quality according to Novotech CEO Alek Safarian.
Proposed changes to USP chapters 232 and 233 on trace impurities would increase drug industry use of automated analysis, creating “huge number” of potential new customers says Thermo Fisher Scientific.
In the first of a series of special in-pharmatechnologist podcasts Kate Wilber, Image Solutions’ (ISI) director of regulatory Services, Europe discusses the emerging trends in BPO and talks about how it can benefit drugmakers.