Summary: Pharmaceutical companies face a number of challenges when sourcing comparator compounds for clinical trials, including addressing product lead times, availability, expiry limitations, safety or cost. This eBook illustrates how clinical trial sponsors can determine the best strategy to meet these challenges...

Summary: Unlike Europe where clinical trial regulations are largely standardized between the EMEA member states, no such organization or harmonization exists in the APAC region, making conducting multi-country studies within the region much more complex for clinical sponsors, particularly with regards to the sourcing...

Summary: Developing, implementing, and managing a clinical trial involves coordination of multiple factors in an ever-changing environment. Recent innovations in trial design and management including a demand-led approach to drug supply, adaptive trial design, mHealth for patient-centric and site-centric trials...

Summary: Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies as the investigational...

Summary: Delayed. Out of stock. Over-budget. Unavailable…All words that clinical trial sponsors never wish to hear in reference to the impact of supply chain performance on their study. And yet, considering the critical role the supply chain plays, it has surprisingly remained largely unchanged for several decades...

Summary: While thorough knowledge of a country’s regulatory requirements is critical, understanding both the written and unwritten regional differences and business practices that come in to play that can make the difference between clinical supplies moving successfully between countries, being detained in Customs...

As certain regions of the world are added to a clinical study, the logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially. While having thorough knowledge of a country’s regulatory requirements is critical, understanding both written and unwritten regional rules...

Successfully navigating the rich and diverse Asia-Pacific business and cultural environment can prove tricky for Western study sponsors with limited experience in this region. Learn what cultural and business norms study sponsors need to be sensitive about in various countries and regions...

Planning to use a CRO to support your next clinical study? Here are the top 9 questions you should always ask to help your CRO or partner of choice better understand your clinical supply needs.

Successfully sourcing commercial products for comparative studies in an effective and efficient manner often proves far more challenging than assumed. A comprehensive plan should include insight from comparator sourcing and clinical supply management. Tight collaboration between these critical functional...