All articles by Surendra Prasad Peravali
Surendra Prasad Peravali
Data control in the clinical trials cold chain
Balancing risk and cost is a delicate undertaking where controlled room temperature clinical trial shipments are concerned. Lisbeth Nielsen, senior clinical supply technician at Lundbeck Pharmaceuticals, tells Andrew Putwain how proper monitoring improves safety and saves money.
Supply chain challenges before biosimilars
Jeff Yant, executive director of global operations at Amgen Biosimilars, discusses the challenges of producing and managing biosimilars. He talks to Sally Turner about supply chain management strategies and explores key considerations for storage, packaging and maintaining temperature control and oversight during transit.
Ensuring drug safety during clinical trials
Risk-based monitoring can promote more efficient data standardisation and speed up clinical trial timelines. Kerry Taylor-Smith speaks to Hanne Cloetta Lang, vice-president at Novo Nordisk Clinical Operations, about how technology can identify critical values in studies to minimise the number of sites monitored and reduce costs.
Integrated data management can cut down trial cost
The digital age is upon us, yet many clinical trials are still rooted in cumbersome paper-based procedures. An integrated data management platform can reduce trial costs and times, as Margaretta Nyilas, senior vice-president, clinical and business operations, at Otsuka Pharmaceutical Development & Commercialization, tells Ross Davies.
Trials and tribulations of clinical trial life cycle
Dr Sanjay Sethi is a leading clinical trials manager in CPOD from the University of Buffalo, with a wealth of experience running trials with corporate and government agencies. He speaks to Andrew Putwain about setting clinical team expectations with early protocol involvement, and the logistical and operational factors one must evaluate when going through a trial’s life cycle.
Unblinded study medication for better clinical trials
Providing subjects with unblinded medication in studies and supplies is fraught with difficulty. Clinical Trials Insight examines how traditional processes cope with the challenge, and asks how studies might be made more flexible and affordable while increasing safety and adherence.
Power of real-world data in clinical trials
With sophisticated technology making it more accessible than ever, real-world data has the potential to transform how clinical trials are recruited and conducted. Andrea Valentino talks to Dr Nilay Shah, chair of the division of healthcare policy and research at Mayo Clinic, about how researchers are improving their trial recruitment procedures – and helping patients along the way.
Communicating clinical trial results effectively can improve public trust
Ambitious new EU guidance on transparency and disclosure aims to boost public trust, but it faces an industry-wide lack of awareness. Eleanor Wilson explores the landscape with Merete Jørgensen at Novo Nordisk and Behtash Bahador of the Centre for Information and Study on Clinical Research Participation.
Improving design of pre-clinical models for better outcome in clinical trials
The overwhelming majority of pharmaceuticals fail when tested on humans, particularly in oncology, where 95% of drugs tested in phase-I trials never make it to market. Kim Thomas speaks with Italo Poggesi, scientific director of global clinical pharmacology/quantitative sciences at Janssen, about how that figure might be brought down.
Bringing together academia’s innovation and pharma’s resources
Tight budgets mean that combining the forces of academia’s innovation with pharma’s resources is happening with increasing frequency. Dr Christopher Milne, associate professor of medicine and director of research at the Tufts Center for the Study of Drug Development, tells Bradford Keen about the popularity of these outsourcing relationships, and why the traditional view of academia and pharma standing in opposition no longer rings true.