All articles by Blatha
Blatha
Play a role: clinical trials in China
Emerging markets offer vast opportunities for patient recruitment and will have a significant role to play in the future of clinical trials. GlobalData analyses subject enrolment in clinical trials in China, revealing the trends that define this important region.
Getting the writing right: importance of medical writing
Gerry McGregor, a principal medical writer at Trilogy Writing & Consulting, explains how experienced medical writers can help medical device manufacturers to meet the new regulatory demands of producing clinical evaluation reports.
Sourcing on a global scale
As more clinical trials are conducted across different regions, it is important for the industry to address the problems in the clinical supply chain that could affect the drug development process as a whole. Dr Cristina Chang, vice-president global clinical development and medical affairs at OBI Pharma, examines the current challenges, as well as critical success factors in clinical trial materials supply for comparator sourcing, and outlines how to simplify the process, eliminate redundancy, and stay ahead of the competition through enhancing customer satisfaction and efficiency.
Sweet harmony: clinical trials protocol template
The increasing complexity of clinical trials, combined with the inexperience of many investigators who write the protocol templates, has long caused concerns. In 2017, US officials responded to the lack of consistency across clinical trial protocols by creating their own model template for investigators to use. How well has it gone down? Neil Thompson explores.
Rules of engagement: patient-centricity and patient management
How do we design trials to be more patient-centric and what can be done to encourage patient engagement among clinical trial teams that works for all involved? Thérèse Johnsen, associate director of patient engagement management at Novartis, provides her insights.
Digital trailblazers
Industry 4.0 promises great things for the pharmaceutical sector, but reaping the rewards of this new technology comes with a number of challenges. Henk Mollee, senior director of clinical trials materials at Astellas Pharma Europe, talks to Grace Allen about the industry’s advances in digitalisation and the factors delaying innovation.
With data in mind: best practice clinical trials management
As the outsourcing of clinical trials increases, maintaining best practice in data management when working with a contract research organisation is of the utmost importance. Grace Allen gathers opinions from industry experts on how to optimise the collaboration between laboratories and the clinical data management team, the role played by new developments in technology and how the delivery of central lab data drives trial timelines.
The legal matter: controlled substances
Working with controlled substances can pose a challenge for clinical investigators. Erica Madison looks at some of the key regulatory considerations and hears from industry leaders on how to move forward with your trial while meeting standards.
Out in the cold chain
It is often the final stage of a drug’s journey that can be the most hazardous. Ensuring the cold chain is not broken means understanding a number of variables and options. Erik Agterhuis, senior manager of logistics and EU supply chain at Kite Pharma, outlines the considerations one must make in order to ensure successful delivery.
Anti-cancer collaboration
Experts at The University of Texas MD Anderson Cancer Center have been talking about its innovative approach to cancer research. By connecting pharma companies with academics, rather than relying on contract research organisations, the team says clinical trial costs can be reduced and drug development accelerated. Abi Millar speaks to Ferran Prat, senior vice-president of research administration and industry ventures at the centre, to find out more about this collaborative approach.