The volume, size and complexity of clinical trials in emerging markets are continuously growing. Therefore the demand for local sourcing of comparator drugs is soaring, putting supply chain professionals under pressure to source sufficient quantities under tight timeframes while keeping up the highest quality level.
While the growing demand for local sourcing is easy to explain, meeting the demand is not quite so straightforward. Compared to central sourcing, local sourcing can be much more complex. Many programs today involve upwards of 30 countries and multiple protocols. Maintaining high quality standards across 30 countries and following the constantly changing regional laws and regulations can be also challenging and needs a profound expertise. Not only the quality and sourcing aspect but as well the compliance to local tax regulations always requires consideration when the comparator is locally sourced and will not leave the country.
The webinar “Local Sourcing for Clinical Trials” will help attendees understand the surprising ways on how local sourcing can offer unique benefits to your clinical program. With practical local sourcing case study examples, which include countries like Ukraine, China, Japan and Russia the challenges and solutions on how to avoid pitfalls when implementing a local sourcing approach will be discussed.
Clinical supply teams considering local sourcing for clinical trials face a whole host of new questions. For instance, when to consider local sourcing and when not? What has to be considered when building up the sourcing strategy? What are the key processes for local sourcing?
When it is available locally, comparators can be less expensive to source in emerging markets than in the European Union or North America. But, the cost of comparators can be also higher locally than in Europe. Furthermore, volatile currency values – stemming from economic or political instability – can cause costs to go up or down rapidly. This significantly raises the likelihood of price increases for resupplies.
The issue of sourcing in-country is not always a matter of choice. Import restrictions in some emerging markets – such as China and Brazil – make it necessary to source study drugs locally. Sourcing drugs through the open local market reduces timelines, as well as the logistical and regulatory burdens required to import products.
Jason Nolte, Comparator Key Account Manager, Fisher Clinical Services
Joining Fisher Clinical Services in March 2015, Jason Nolte serves as a Comparator Key Account Manager in North America. In his role, Jason is responsible for supporting the strategic success of Fisher’s comparator sourcing projects. Jason has 14 years of industry experience, having worked for different biotechnology and Pharmaceutical companies, the majority of this time within clinical supply chain management.
Jason has a broad knowledge and a wealth of experience managing strategic comparator sourcing projects, both centrally and locally. The speaker knows the latter not only from working for Fisher Clinical Services, but also since he was working for a global leading Pharmaceutical company and navigating multiple local sourcing projects in Russia, Ukraine and India. Jason has a thorough understanding of how comparator product selection and sourcing must align with regulatory, resources and corporate capabilities while minimizing waste and maximizing efficiency, compliance, and patient safety.
Who Should Attend?
Clinical teams, plus professionals in clinical supplies, logistics and outsourcing, including those working within:
- Clinical Supply Team
- Comparator Sourcing Team
- Clinical Management
- Procurement Team
- Clinical Trial Team
- Supply Chain Department (CRO)
- Clinical Development
- Investigator Dites
- Clinical Operations
- Clinical Supplies & Investigational Supplies
- Clinical Packaging
- Clinical Labeling
- Clinical Quality Assurance/Quality Control
- Regulatory Affairs
- Clinical Project Management
Fisher Clinical Services
Fisher Clinical Services is the world’s leading provider of clinical supply chain services.
With a network of cGMP facilities strategically located across the globe to support the conduct of clinical trials, we offer worldwide support for all aspects of clinical supply management including, clinical supply optimization, comparator, co-medication and ancillary supply sourcing, packaging, labeling, distribution, storage, through to returns and destruction. With more than twenty years of experience exclusively focused on clinical trials, we can offer guidance and full logistics support across all types of clinical programs and projects.