Pharma industry sponsors want more effective ways of measuring CRO performance according to the team behind a new project aiming to develop a validated set of analysis tools.
Companies outsourcing patient recruitment in emerging markets should have more people on the ground, according to Cutting Edge Information's Shaylyn Pike.
An evidence-based approach to planning during protocol development is key to successful patient recruitment according to Joseph Kim, director of clinical operations at Shire Pharmaceuticals.
INC Research CEO James Ogle tells Outsourcing-pharma.com that the acquisition of fellow CRO Kendle was about building a presence in emerging trial hotspots and pharmaceutical markets.
Firecrest Clinical has launched a mobile version of its site management and training platform, citing investigator demand for trial in your hand solutions and sponsor demand for increased research efficiency.
Pharma needs to learn from other sectors and abandon the multistage development paradigm in favour of a two-stage design and manufacturing model to cut attrition rates.
Continuous manufacturing offers significant advantages for drug production in terms of quality and efficiency, but more research and regulatory input is needed to help the pharmaceutical sector reap the benefits according to ISP.
LB Bohle says healthy level of demand for processing technology demos at its recently opened service centre is an indication of processing tech market recovery.
The biomanufacturing industry needs to adopt an integrated approach to upstream and downstream processing to boost efficiency and productivity according to EMD Millipore.
ATMI LifeSciences has introduced a new method of integrity testing for its range of single-use bioprocess vessels that, it claims, will take QA in the biomanufacturing sector to a new level.
Next month the United Nations Conference on Trade and Development (UNCTAD) will organise a meeting to discuss ways of encouraging the production of pharmaceutical in Africa.
CRO and Pharma patient recruitment efforts can benefit from social networks and online patient groups, but clarification from the US FDA is still needed.
Big pharma has taken a less heavy handed approach to relationships as cutbacks have made outsourcing key, according to Stephen Munk, CEO of Ash Stevens.
Solvent selection and solid loading are critical to optimising the spray drying process and unlocking its solubility-enhancing properties for drug production according to a new report by ISP Pharmaceuticals.
Kerri Weingard, research director for Accumed, says the growing numbers of patients enrolling in multiple clinical trials are threatening the integrity of the clinical development process.
Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
Almac invests $4m in biocatalysis R&D, describing such technologies as the way forward for the cost efficient production of highly chiral APIs and intermediates.
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.
Adoption of electronic submission by regulators around the world is good news for drugmakers’ efforts to access emerging markets says industry expert Kate Wilber.
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.
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.
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.
The role of the pharma industry in supporting the COE anti-counterfeiting treaty, which aims to criminalise activities, “cannot be underestimated”, according to a directorate member.
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.
Aluminium foil as a packaging solution is marking its centenary in 2010. Stefan Glimm, executive director of the European Aluminium Foil Association (EAFA), reflects on how this packing mainstay continues to build on its ability to provide the highest...
