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Latest World Pharmaceuticals Feature
Lisa Chamberlain James of Trilogy Writing & Consulting and Trishna...
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All on file Given the new EMA guidelines put in place to assist sponsors and investigators with clinical trial master file (TMF) requirements, it’s more important than ever to work closely...
No clear path Driven by ethical considerations and the aim to gain an edge within drug approval, comparator use is growing steadily in clinical trials. However, implementation is by no...
Central to success There is increasing emphasis on the importance of patient-centricity within clinical trials, including encouragement from the FDA to incorporate the patient voice through the...
The mind leading the blind Interactive response technology (IRT) systems are crucial to the efficient management of clinical trials. The medium has evolved from a telephone-based interface to one based...
All things considered Every clinical trial needs not just the investigational product but a host of ancillary supplies, ranging from laboratory equipment to the paper required for audit trails. Kim Thomas...
The cold war Cold-chain shipping involves navigating a number of challenges to prevent product wastage. Eva-Lotta Persson, MSc/CSCP clinical supply chain lead, AstraZeneca R&D Mölndal, speaks to...
The heat is… off Temperature-controlled products present a logistical challenge. Their safe transportation and storage are essential to their efficacy. Ensuring effective infrastructure and maximising...
Stamp of approval For years, clinical trials have been stymied by confusing regulations and high levels of patient drop-out, all of which wastes money and prevents drugs from getting to the people who...
Trial by comparator Comparator sourcing is often an essential element of successful clinical development programmes. However, securing a reliable supply requires navigating operational, regulatory...
Choose wisely Choosing the right vendor is a hugely important aspect of planning for a clinical trial. There are a number of different factors to consider when working with these contract...
Chain of command There are a number of technologies available to accelerate the trial process, paving the way for a new paradigm. Leeza Osipenko, senior lecturer in practice at the London School...
Only as strong as the weakest link Pharmaceuticals are particularly difficult to transport, with a number of potential areas of weakness within the supply chain. Greater data sharing between partners can...
Connect the dots AI is set to play an increasingly important role in the pharmaceutical industry, providing life science companies with faster, more efficient ways of uncovering drugs, sourcing data...
The first move There is increasing talk of ‘patient-centricity’ within the industry. Incorporating this concept into drug delivery can be challenging but provides huge opportunity to improve...
The circle of life Manufacturing a cell or gene therapy is difficult and costly. Unlike other types of drugs, these living cells demand a sophisticated and circular process that is individuated for...
Risk versus reward For parenteral drug products, there is a need to further investigate the materials that will be in contact with the drug product during manufacturing, storage, final packaging or...
Top of the green chain Pharmaceutical companies have long grappled with getting their supply chains in order, especially when it comes to keeping them sustainable. But between lax reporting and...
A helping hand Since 1997, pharma has been looking at additive manufacturing (3D printing), trying to understand what role it will play. Its value is clear, but to pinpoint where it should be used...
Piece by piece For over 20 years, contract manufacturing organisations (CMOs) have played an increasingly important role in the pharmaceutical industry. The need to lower the time to market,...
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