All articles by chris cox
chris cox
Virtually there: the power of IRT
Interactive response technologies (IRTs), including voice and online systems, have been employed for many years as a means of increasing the efficiency of clinical trials, but there has been a marked shift towards web-based technologies over voice-response systems. The challenge now is to maximise efficiency gains by more rapidly making IRTs study-specific and integrating them with other systems vital to trial management. Pfizer’s Michael Moorman tells us what is being done to achieve this.
Better together
GlobalData reports on the latest developments and trends in a buoyant CRO sector, which is seeing an increase in revenue as drug makers look to tap into the cost savings these companies are able to provide.
eCTD submissions made simple
Preparing submissions in the eCTD format normally requires significant time for detailed planning and follow-up, while data flows from diverse systems must be brought together. Document management systems do make collating data simpler, but Mitsubishi Pharma Europe’s Dainius Ulpis believes the principles behind good data management ought to make submissions relatively straightforward.
Critical factors in CRO contracting
The drive to outsource key elements of the clinical trials process is no longer driven solely by cost considerations, but is increasingly about the pursuit of high-quality services. This change in emphasis makes the selection of the right CRO partner crucial to the success of a trial. Clinical Trials Insight speaks to Almirall’s Dr Estrella Garcia about the key factors to consider when choosing a CRO.
Cold room: mapping out the future of storage
The cold chain is often thought of in terms of products on the move and, therefore, how to maintain their integrity while in transit; equally important, however, is the storage stage. Maintaining products within required temperature ranges while in the warehouse is essential, so temperature mapping is a vital process. Jim Banks speaks to Octapharma’s Marc-Oliver Rechsteiner about the key considerations for the warehouse in the context of the cold chain.
The growing case for reusable packaging
In a world that is increasingly waste conscious, the appeal of reusable and recycled materials is growing in many industries, not least the pharmaceutical sector. Reusable temperature-controlled packaging for investigational medicinal products is an option more companies are choosing in their logistics strategies for clinical trials. We hear from industry sources about the impact this is having on distribution processes.
Multisorb at MEDICA
Multisorb Technologies, a provider of sorbent and desiccant products for the healthcare market, will be among the 4,500 exhibitors at this year’s MEDICA/COMPAMED trade fair.
Pep talk
Peptide therapeutics have been around for decades, but in recent years, there has been an upswell in interest among pharmaceutical companies. Ever-improving technologies have overcome some of the barriers to effective treatment development, and the industry increasingly sees them as more flexible and cost-effective than their biologic equivalents. Dr Joël Richard of Ipsen provides a peek into what the future holds for peptides.
Online application
Marketing authorisation applications are becoming larger and increasingly complicated, and the switch from paper to electronic dossiers in recent years has added to the overall complexity of the process. GlaxoSmithKline’s Alastair Nixon examines how the electronic common technical document’s implementation as a global standard affects verification on a regional level.
The complete guide through the pharma product chain
There needs to exist a synergy between process validation and quality by design. Peter Amanatides, vice-president of quality assurance and quality control at Noven Pharmaceuticals, looks at the importance of regulation and guidance throughout the pharma product chain.