Operational Imperatives within Clinical Distribution

As we embark into 2016, I’m reminded of some operational observations that have been instrumental as “sound practices” within my clinical distribution experience.  This brief serves as consideration to assess, and possibly incorporate some of these concepts into your specific area of practice.  The intent is not to generate new tactics within your clinical distribution strategy, but to share various perspectives on what principles assisted me in the course of overseeing clinical operations over the last ten years, and how they could possibly align with your organization.

Know your supplier’s strengths and limitations

One initial observation learned many years ago, is that most service providers such as couriers, clinical manufacturers and other providers within clinical services have unique skills and offerings, but generally cannot do all the things they claim within their literature.   In your due diligence in selecting or maintaining a service provider dedicated to your clinical needs, please ensure they provide testimonials, or more importantly, primary contacts from companies similar to your operation so you can conduct a thorough review of capabilities with an impartial user.  If possible, and if your Industry allows, consider visiting that colleague’s facility to interact regarding implementation or challenges encountered as the competitor brought that respective provider on board.  It’s been my experience that most have been very forthcoming to assist, as within the Pharmaceutical Industry, we all seem to encounter similar logistical challenges.

Also ensure your internal Procurement and Quality colleagues are actively engaged in your development and that they support sustaining relationships with key suppliers.  Recognize they may have overarching responsibilities with other business units within your organization.  Both these departments will provide key tools such as Master Service Agreements, Technical and Quality Agreements, as well as operational metrics and establishing periodic strategic and tactical business reviews.  They’ll also serve you well when considering request for quotes, or for bid proposals.

Temperature management considerations

Depending on whether you are directly responsible, or if this is outsourced to a service provider, it is critical that you gain a comprehensive understanding of what temperature shipment options are available and required based upon regulatory compliance, as well as evaluating risk of clinical materials in your supply chain.  Once again, this suggests a variety of shipper and temperature monitor options to consider based upon conditions; such as, but not limited to, value of the commodity, product availability, seasonality, distance traveled in the supply chain, end user expectations and regulatory adherence.  This again is a good opportunity to work with your Regulatory and Quality colleagues to gain their perspective and understanding of guidelines, especially if shipping globally.

Technological advances in temperature monitoring and packaging are also very dynamic, so make sure you establish and maintain a continuous dialogue with both packaging and temperature monitoring companies, as the expertise is best positioned within these companies.

Gain a more comprehensive understanding outside your area of expertise

If your focus is primarily distribution, consider working with the packaging colleagues, clinical pharmacists or with the clinical research associates to gain their input on what works well, (or not so well) when shipping to the clinical sites.  One primary example from the clinical sites is the challenge and potential cost of disposing thermal shippers versus the use of returnable containers.  Another consideration is recognizing some technical limitations and policy restrictions sites might encounter with temperature monitor uploading via the recipient’s computer network.  Although you think your methodologies are well thought through, it is critical to understand what the end users are encountering, and prepare contingencies to mitigate these potential challenges

These observations are just a sample of challenges within distribution, but the key is recognizing there are multiple solutions and your ability to be agile and adaptive to changes is paramount to continued logistical success.

Author:  Bruce Guenter

Bruce Guenter has worked within the life sciences industry for more than 30 years, most recently with Pfizer, Inc. and Wyeth Research.  He is currently transitioning to other Logistics / Supply Chain opportunities within the Life Science Industry.