These are unprecedented times, but the need for stable and consistent comparator sourcing remains as necessary as ever. So what does it take for both suppliers and sponsors to surmount these odds? What steps can be taken to identify and develop robust comparator sourcing solutions?
The coronavirus outbreak has created new and significant challenges for comparator sourcing companies and clinical trial sponsors — how many of us had ‘global pandemic’ in our business.
Continuity plans? Some governments, in countries such as Romania, India and Italy, have banned the export of certain active pharmaceutical ingredients (APIs) and finished products and, where exports remain possible, manufacturers are likely to be operating at a reduced capacity and keeping back contingency stock for hospital supplies. Uncertain times, however, require a proactive response. With careful thought, planning and execution, it’s possible to identify and develop comparator sourcing solutions that can ride the wave of this current crisis. At the end of the day, the key elements of successful sourcing and distribution — such as lead times, reliable suppliers, product shelf-life — have not changed; it’s that attention to detail and being on the front foot are more important than ever.
Here are four factors that are critical to strengthening supplier-sponsor relationships and ensuring stability in uncertain times:
1. Managing expectations with clear communication
Maintaining excellent relationships between all parties during a stressful season — both financially and logistically — will depend on realistic expectations. It’s unreasonable to pretendthat everything can continue ‘just as before’; projects will almost certainly move slower than is desirable, because manufacturers are very cautious and conservative with stock allocation. This is why regular, clear communication is essential for informed and fast decision making, and
2. Mitigating risk
Supply chains were complicated before the outbreak of COVID-19, now they are even more complex. It’s important to stay abreast of developing situations across the globe: Is there the
The danger of a country banning exports? What medicines are being held back for contingency stock? Are any warehouses temporarily closing for cleaning? At CSI, we thoroughly evaluate any and all risks associated with the countries we are working in, informing our clients as soon as information becomes available and highlighting potential pitfalls in the road ahead.
3. Exploring multiple options
At times like these, a client needs options. A comparator sourcing company needs to provide as many alternative solutions as it can, and early planning and sourcing products with a long shelf-life will be important in offsetting the problems of potential delays. If plan A becomes problematic, there needs to be solid, workable option B, and perhaps even alternative C. Just recently, CSI was tasked with securing €1 million stock for a clinical trial, and we identified two possibilities: a supplier in Bulgaria with a lead time of several weeks, or a more expensive supplier in Germany with a much shorter lead time. Our client chose to go with the latter — prioritising speed over cost — and we were able to promptly supply the comparators.
4. Invest in your network
At CSI, we're proud of the extended network of manufacturers and audited suppliers that we have established. For example, we recently set up a supply chain in a matter of weeks to deliver oncology products to hospitals in Turkey for a top pharma company. One of the project managers was so impressed and commented that we had achieved what a 100,000 strong company could not. I don’t mention this to blow our own trumpets, but to highlight that having a strong network vastly outweighs human resource in setting up distribution, and CSI will continue to invest heavily in building relationships with suppliers and manufacturers over the coming months.
If the current coronavirus crisis teaches us anything, it’s that the future can be even more unexpected than we anticipate. Times have changed for now, and today’s situation may simply become the ‘new normal’, preparing us to adapt and respond even more quickly than before. We must not halt the progress of medicine; clinical trials still need to go ahead, not least those that are specifically addressing this outbreak.
At CSI, we remain as committed as ever to ‘delivering the impossible’, working with our clients to provide the best outcome and ultimately improve patient care.
Please get in touch about comparator sourcing and how we can help to make your clinical trial a success.