Studies conducted according to the rules – just more quickly
Even quite a simple study can take two years or more to progress from concept to initial results. SWIPP constant aim is to reduce the length of this process as much as possible – without compromising neither the quality of the studies nor the safety of the study participants.
However, clinical studies always require extensive preparations. This also applies to short-term studies involving healthy trial volunteers. The purpose and design of the study must be determined, a detailed study protocol must be produced, together with a detailed description of the investigational product that will be used. A number of authorisations are required: authorisation to conduct a clinical trial from the relevant medicines agency, approved application for ethical approval, as well as import and export licences for products containing narcotic substances, which was the case for our midazolam studies. Finally, a GMP batch of the actual investigational product must be manufactured and the comparator product must be procured and imported.
An additional challenge is that numerous different parties are involved, in addition to the sponsor (i.e. SWIPP). Contract clinics (CROs), GMP manufacturers, transport companies, monitors, pharmacovigilance, and so on, which all requires coordination and smooth cooperation.
XXXX represents the name of the comparator product, which SWIPP prefers not to disclose here.
When preparations begin for the next clinical study, information will be made available on this website
SWIPP’s products must be safe to use
All the studies conducted so far have been deemed both conclusive and successful. They have enabled each project to progress to the next stage and have also increased SWIPP’s general insights regarding the bioavailability of midazolam. An equally important outcome has been that the studies have supported the assumption that SWIPP’s products are safe to use. A total of about 100 doses of SWIPP’s films have been administered to a total of about 60 trial subjects. None of the infrequent and mild adverse events (AE) that were observed during the studies were deemed to have been caused by SWIPP’s film.