Orphan Drug Trials: Putting the Patient First

Oct 27, 2015

Over recent years, there has been a notable increase in the number of orphan drugs being successfully brought to market. Here, Jennifer Peters of Greenphire speaks to International Pharmaceutical Industry about the orphan drugs market, the unique logistical challenges faced by organisations when conducting clinical trials for this type of drug, and how addressing payment processes and financial management strategies can overcome them. ...

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Delivering Patient-centric Support Services in Clinical Trials

Oct 27, 2015

While patient safety is paramount in clinical trials, there are a number of additional key patient concerns, including recruitment, engagement, retention and compliance. Patients also require significant support throughout a trial for scheduling visits, visit/ medication reminders, completing diaries/questionnaires, emergency medical enquiries, technical device enquiries and simply questions related to their involvement in the trial. Julia Lakeland at PAREXEL shares her thoughts on patient-centric support services in clinical trials. ...

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Comparator Sourcing – An Analytical Approach to Find Best Suited Sourcing Strategies

Oct 27, 2015

Sourcing comparator drugs for clinical trials is a complex process, especially for branded drugs, and in many cases the selection process to find the best sourcing partner falls short of expectations. An analysis has shown that around 30-55% of comparator drugs are left unused at the end of the trial. This is due to issues such as disruptions in the supply chain, unexpected delays, incomplete paperwork, stock-out situations and regulatory hurdles. Mark Walls at Verastem Inc., Rahul Sodhi of Beroe Inc. and Dr Mihai Bragaru of Durbin PLC reflect on comparator sourcing. ...

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