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In the most high-stakes cases, the right choice in comparator sourcing...
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A matter of life and death Clinical trial supply professionals have long understood the importance of remaining agile in keeping up with increasingly complex trial demands. Now, with Covid-19,...
Open questions It’s been a slow, piecemeal process, but in recent years regulators have begun to develop a framework for using real-world evidence (RWE), shining a light on the important role it...
Ghost writer Medical writers have tried just about every technique to speed up the process of producing clinical study reports, but strict schedules and inspirational project management can only...
Simply does it In recent years, Sanofi has emphasised the importance of direct-to-patient trial supply in laying the groundwork for a more patient-centric clinical research model. Even so,...
In good form With many Covid-19 patients too ill to make their own decisions, treatment data needed urgently and human challenge trials being mooted as a possible way to expedite the development of...
Assistance, acceleration and augmentation AI is set to play a significant role in regulatory and medical writing in the very near future. Dr Barry Drees of Trilogy Writing & Consulting, using his more than 30 years of...
There and back again As perilous as the journey might get, unused investigational products need to come home. Kevin Crawford, head of clinical operations at Tenax Therapeutics, has made drug reconciliation...
This information may be suitable E-labelling promises many benefits for clinical trials, from encouraging regulatory buy-in to enhancing supply chain planning, yet it has not gained the traction that some might like...
Alive and well Emerging stem cell and gene therapies provide unique challenges in a number of areas, including vendor selection and procurement. Emma Green speaks to Jacqueline Barry, chief...
Hand in hand Clinical supply teams work hard to ensure the correct amount of medication is available where and when patients need it. Too little leads to trial delays, while too much...
Tech injection Technology is having a huge impact across all industries, and pharma must keep pace to avoid being left behind. Digitisation offers huge potential for improving patient...
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...
Lay summaries and writing for patients
Lisa Chamberlain James of Trilogy Writing & Consulting and Trishna Bharadia, patient
engagement consultant, examine the trend for increasing and more transparent...
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...
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...
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 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...
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...
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...
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