How to meet SIV dates
Drug development is an arduous journey of many stages but one of the final hurdles is the ever-important clinical trial. This can only proceed after a site initiation visit (SIV) and, for that, several crucial questions must be answered, each with its own challenge. What are the study requirements? What’s the project lead time? How long will it take to order the items from the supplier? What are the regulatory considerations, and how long will equipment take to clear customs? To name just a few. For an equipment provider, success in helping sponsors meet their SIV dates boils down to efficient operation of, and perfect synchronization between, three intertwined departments: sales, procurement, and logistics.
Three steps to SIV success:
1. Sales – the start of the final leg
Understanding the intricate and often very specific study requirements is the first step to nailing down the SIV timeline. Developing a partnership will ensure we know the ins and outs of your study, the exact equipment that is needed, and the level of data that must be collected and analyzed. We can then put forward our core products and match them to what is required, or otherwise look further afield for a tailored equipment solution. Even then, prerequisites are exactly that, and will often change in the lead up to the SIV, requiring swift agility to stay on course. This early planning is perhaps the most critical step for ensuring a sponsor meets a planned SIV – after all, this will dictate specific timelines for subsequent procurement and logistics.
2. Procurement – sparing no effort
The vast array of regulations, documentation, and licenses for different types of equipment that is being transported around the world can feel like navigating a minefield. Procurement is knowing exactly where to source the best equipment, how to get it where it needs to be, and solving the regulatory intricacies associated with every country, as well as – perhaps most painstakingly – all the different certifications, forms and documentation that accompany each border crossing. For example, did you know that all electrical equipment that arrives in China needs 3C certification, but sourcing it from within the country removes this extra step, and the complexities associated with customs that can cause significant and unnecessary delays? Or that there are two types of imports into Brazil, one a formal clearance, the other informal – each with their own requirements? These policies can impede timelines if unprepared and may require out-of-the-box thinking, such as hiring a broker to organize an import license and speed up uncontrollable custom formalities.
3. Logistics – putting the pieces together
‘How long will the equipment take to be delivered?’ and, ‘what’s the most efficient and cost-effective transportation method to get it on site?’ are potentially two questions that only an experienced logistical team can answer. Logistics and supply chain management are multifaceted parts of the process, requiring solutions to help expedite supply of equipment. One way we achieve this is by ensuring core products are stored in strategic locations. For example, we have a storage facility with our strategic distribution partner in the Netherlands, meaning we can dispatch equipment with incredibly short lead times to most locations in Europe. Similar scenarios are set up in the US and Japan, allowing consistent delivery of equipment to hit promised SIV dates, sometimes even with a shockingly short lead time.
Sometimes, owing to uncontrollable variables, reaching a 100% SIV success rate is simply not possible. The growing uptake of decentralized trials adds further challenges to reaching that perfect goal – hearing suppliers boasting extraordinary numbers must be taken with a pinch of salt – however, at Woodley Trial Solutions, this is something we excel in, with our approach honed even more in the face of the COVID-19 pandemic. We are very focused, leaving no stone unturned to ensure that we hit as many SIV dates as we can, and that any delays are kept to an absolute minimum. This is because we are dedicated to your study, diligent with procurement and passionate about logistics, and know exactly how to traverse the regulatory frontiers. We back this up with 30+ years of experience that helps to dampen the complexities often threatening SIV success.
Have you experienced poor SIV success rates with your clinical trial product supplier? If yes, then please get in touch and let us show you how we can help.
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