Company insight
An end to the stress of clinical trial supplies
Clinical trial sponsors want to focus on their core competencies of drug and device development, but the trials themselves often become mired in logistical and material complexity. A new model is emerging that takes the strain off their shoulders and ensures ancillaries are delivered on time, every time, with the expertise of Labfi sh Clinical Trial Supplies, co-founded by Martin Forster and Dr Meike Fischer.
etting a clinical trial up and running is no small feat, particularly if it is a global study involving many sites, a large patient population, and a complex array of equipment and materials. Sponsors are experts in drug or device development, so why do they so often get stuck in the weeds of sourcing equipment and ancillaries for trials?
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As clinical trials become more complex, as the regulatory oversight of patient safety and data security becomes more intense, and as the sheer number of trials skyrockets, drug companies and medical device manufacturers face an uphill struggle to get trials to run smoothly and deliver results on time. Frequently, this is because of technical issues, not least the sourcing of all the instruments, equipment and consumables that are required at every test site. Trained chemist Martin Forster and Dr Meike Fischer, who has a PhD in virology, have seen the clinical trials process up close, and they understand how easily clinical studies can get bogged down in the details of sourcing ancillaries – all of the non-drug components that are needed to deliver treatment and measure results. That could be anything from syringes to infusions, refrigerators to centrifuges. Understanding that trial sponsors are not experts in sourcing, inventory management, logistics and distribution, they co-founded Labfish Clinical Trial Supplies to address all the complexities that come with ancillaries. “Many sponsors have traditionally leased equipment the way you might lease a car – but those agreements can be rigid and limiting, often locking you in for three to four years,” explains Forster. “Our flexible rental service breaks free from
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Martin Forster, co-founder, Labfi sh Clinical Trial Supplies
Dr Meike Fischer co-founder, Labfi sh Clinical Trial Supplies
that model, giving sponsors the freedom to scale up or down as needed, without the long-term commitment or hidden constraints of standard leases.”
Sponsors need to work closely with any service provider at the planning stage, but once the parameters are set, they want to step back and focus on more strategic matters. For a service provider like Labfish, this means developing a full suite of services, starting with equipment selection. All equipment needs to be qualified for the trial, and any differences in regulatory regimes across different sites must be taken into account.
“If a study was designed in the US, it may, for example, use an infusion pump that has been cleared for use in the US but that may not be registered in the EU,” says Forster. “A client can simply throw us a list of what they need, and we can make suggestions that are suitable for different regions. “It all starts with laboratory manuals and
“We deliver to trial sites any equipment, ancillaries and consumables – everything but medications – along with comprehensive services to support them.”
Martin Forster
“We work for global pharma clients or biotechs that do clinical research either directly or through CROs,” he adds. “We deliver to trial sites any equipment, ancillaries and consumables they may need – everything but medications – along with comprehensive services to support them.”
Fully committed to flexibility At the heart of an outsourced clinical trials supplies service is the understanding that sponsors want to stick to their core competencies and leave the details of ancillaries sourcing and logistics to a trusted service provider. They want to rest assured that everything a trial requires will be in situ before the trial begins.
trial protocols, which are translated into a list of actual devices that can be used,” he adds. “The study team may not have the expert knowledge of equipment that the laboratory team had, and this can be quite a tricky problem. Some items may not be the most suitable for all sites, so finding what they need – sometimes from a vague description – can be challenging.”
Once the equipment requirements have been finalised, the next challenge is sourcing everything on the list in the right quantity, making it available on a rental basis, and getting it to the sites. Labfish can deal with multiple vendors to reserve and stock devices in sufficient quantities to meet sudden changes in demand quickly, so that
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