Mark Weinstein, CEO of Bioclinica, has hit back at a public letter from Nicusa Capital CEO, Paul Johnson, claiming that the company's corporate strategy is 'flawed' and demanding the resignation of three top executives.
The US FDA’s risk evaluation mitigation strategy (REMS) can be a challenge for pharmaceutical companies unfamiliar with the process according to PPD’s executive director of risk management Frank Gallo.
Addressing the drug industry's need to demonstrate value to stakeholders presents a significant opportunity for service providers, according to Jim Featherstone, VP of Quintiles' commercial arm.
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.
Demand for drug discovery services is growing again according to Domainex, who predicted that we will see greater pharmaceutical industry reliance on specialist CROs going forward.
CRO Quintiles says biomarkers give insight into cancer drug candidates’ efficacy earlier in the development process, reducing trial costs and duration.
Quintiles’ Jay Norman tells Outsourcing-pharma that data sharing and patient and payer concerns will drive drug industry competition and clinical development decisions accord to new research.
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.
Russia, the Ukraine and Belarus have emerged as destinations for clinical studies and now offer “enormous” potential according to US-based CRO ClinStar.
