To effectively manage supplies, pharma companies must automate the restocking of sites and depots across the supply chain. ClinicalTrials.gov reported that as of March 22, 2016, there were more than 211,000 registered clinical trials taking place. In 2010, there were just over 83,000. This increase of over 150% in just six years demands that clinical researchers have systems in place that automate the intricate supply process so that they can focus on the research and decrease the potential for human error.
 
In an effort to simplify the clinical trial supply management process, companies can use technology such as Interactive Response Technologies (IRT) to help automate the restocking of sites and depots across the supply chain, help address supply issues, and support supply chain forecasting, temperature-sensitive supply management and direct-to-patient supply management.
 
Sanjay Vyas, Corporate Vice President & Global Head of Clinical Trial Supplies & Logistics, PAREXEL discusses clinical supply chain complexities and ways to help overcome them. – KB
 
Contract Pharma: How are pharma/biopharma needs changing with respect to clinical supply? What services are most in demand?
 
Sanjay Vyas: As pharmaceutical and biopharmaceutical companies expand internationally, their clinical supply and logistics needs expand as well. With that comes the increased complexity of managing these supply needs globally. Clinical development is truly global in nature, and an effective trial supply chain management requires a supplier that can consider the site of bulk drug manufacturing and then employ an extensive network of well-positioned clinical packaging and distribution sites based on the strategy.
 
Based on the current market demand, we recently announced our new North American Coordination Hub and Distribution Center, which is part of our global depot network of clinical logistics facilities that can serve both small regional studies and large complex global trials.
 
With the complex trade regulations and diverse geographical locations, customers are looking forward to a GDP / GMP compliant network that has the ability to meet end-to-end supply chain management and clinical needs with a “Cradle to Grave” concept.
 
CP: What are the main challenges managing clinical supplies and how can they be addressed? 
 
SV: The key challenge around managing clinical supplies is ensuring 100 percent supply chain continuity across the study life cycle in the most compliant and efficient manner. The center of global packaging, labeling and distribution lies in an efficient hub and spoke model that is well-executed and supported by high standards of compliance and regulation.
 
The majority of today’s investigational medicinal products (IMPs) require temperature control, especially in the realm of oncology and large molecule research. To achieve this, supplies must be packaged, stored and transported in appropriate conditions (typically around 2–8°C), making use of such tools as temperature monitoring devices, temperature controlled shipping containers and track and trace technology.
 
CP: What are the challenges around supply chain forecasting?
 
SV: Supply chain continuity is key. Pharmaceutical companies and biopharmaceutical service providers work for months and years on clinical trials. During this time, it is essential that the supplies needed are shipped on time, to the correct trial site and in a manner compliant with Good Distribution Practice (GDP) and all regulatory standards. And it’s not always easy to perform effective supply chain forecasting due to the complex study and patient environments.
 
It is thus critical to have technologies, such as interactive response technologies (IRT), to help manage effective supply chain planning and forecasting process. IRT in the future may also have the potential for temperature data tracking right from the depot to an investigator site and beyond, thus fulfilling the vision of near real time end-to-end temperature monitoring and tracking.
 
Our ClinPhone RTSM (Randomization and Trial Supply Management), for example, is designed to simplify patient randomization and clinical supply management and to offer flexibility in tailoring the service to meet the needs of clinical trials. The technology is designed to increase the predictability of treatment allocations and manage trial supplies, including minimizing drug wastage by enabling automated site restocking. Automatically restocking clinical research sites ultimately decreases the cost of shipment and decreases the risk of supplies arriving late or being miscalculated.
 
CP: What factors must be taken into consideration with clinical supply logistics?
 
SV: There are two main factors that contribute to clinical supply logistics: the length of the trial and its location(s).
 
The length of the trial is crucial to determine the quantity of supplies that the trial will need over time. If a trial lasts one year, it will require much fewer resources than a trial that lasts five years. This knowledge will help the pharmaceutical company to determine its supply and demand levels and timeline. Additionally, the longer the clinical trial, the higher the costs associated with that trial. This is not to say that all clinical trials should be shortened to decrease budgets; the personnel staffing the clinical trial and the pharmaceutical companies organizing them understand that time must be taken to ensure that the results of the trial are valid, and this often takes time and patience. And most importantly, it’s backed by an effective supply chain planning.
 
The location of a clinical trial determines where it will receive its supplies from. If a clinical trial is taking place in one location, it is generally simpler to determine where it will receive its supplies from and how often it will receive them. If a trial takes place in multiple locations, this poses a more complicated challenge. It will be important to time the delivery of supplies for each location precisely and ensure that the exact quantity of supplies arrives at each location. To ensure that all of the correct materials arrive together, PAREXEL’s new North American Coordination Hub and Distribution Center can consolidate all clinical trials supplies, as well as ancillary and lab supplies into a “study in a box.” Designed to reduce the risk of misplaced materials and increase inventory transparency, study in a box can reduce shipping costs.
 
Finally, it’s important for customers to consider a supply chain optimization plan as well. Many times the optimization focus is lost because every study or protocol is evaluated individually based on its supply chain needs. Hence as a supply chain head, if you are able to effectively forecast your clinical study needs in the pipeline and then effectively plan the logistics needs around it on a long term basis, this can help drive better planning and optimization in the long term.
 
CP: What are the major supply chain hurdles experienced today? How can they be overcome?
 
SV: One of the main supply chain hurdles experienced today is the unpredictability of clinical trials with an increase in more biological studies that need stringent cold chain management. While researchers can predict a number of things, such as the number of patients taking part in a clinical trial or where the trials will take place, they cannot predict everything. Patients can drop out of clinical trials, supplies may not make it to the clinical trial sites in time, or their quantity might be miscalculated or the efficacy of the drug might become compromised due to non-availability of a good cold chain network. Random, unpredictable changes are sometimes unpreventable and biopharmaceutical service providers and biopharmaceutical companies need to be prepared for rapid changes in study design and be able to quickly adjust to evolving studies to provide supplies in time with compliance in mind and continue the clinical trial rather than disrupting it.