We specialise in managing medical device studies, whether to support regulatory approval or to gather real world evidence as part of PMCF plans as requested by EU or UK medical device regulations.
The start point for gathering great clinical data is the design of your study. With an experienced team managing your sites we aim to maintain a high level of patient recruitment, capture accurate data and ensure the best outcomes from your study.
Clinical Services
Protocol design
Ensuring you have a recruitment target to enable a robust statistical power.
The right primary and secondary outcomes to support a data set that meets the needs of your end customers.
A sound commercial argument for the use of your product once the data is available.
Principal Investigator and site selection
With an experienced team we can assist with selection of your chief and principal investigators.
Having motivated sites is crucial to any study, as is making sure that sites have the capability to effectively deliver your study. We qualify sites to ensure that they have the clinical study teams in place to be able to effectively set up and manage your study.
Publication
We support you with medical writing and publication of your study.
Choosing the right journal to publish your study will ensure you maximise your exposure with your target audience.
Maximise your opportunity with key customers
Spending time in your priority centres and building relationships with key clinical staff will pay dividends when it is time to commercially launch.
Where possible we assist trial centres to utilise products commercially alongside the study.
What our clients say
Get In Touch
Our team is ready to help, whether you need support to deliver a clinical study, strategic commercial guidance to launch your products or simply on-the-ground sales support please make contact to arrange a call.