The team at Artemida Pharma have significant experience of clinical drug development with a particular emphasis on early phase clinical trials. We can provide expert oversight of clinical trials or ad hoc input for the specific challenges faced by our clients.
We can introduce clients to our network of Key Opinion Leaders - practising physicians and academics who are experts in their field. We can set up Scientific Advisory Boards and Focus Groups to provide independent advice at any stage of the drug development process from indication-seeking to design of Phase III trials. We have a large database of experienced advisors and can put together a board that is specific to the product’s therapeutic area. As well as arranging the meeting logistics, we can provide an agenda and professional facilitation to ensure that our clients’ objectives are achieved.
Artemida Pharma’s consultants have decades of experience running clinical trials particularly first-in-human and early phase studies. We can provide complete oversight of trials from writing protocols, to liaising with sites, to analysing data. We have strong connections with a network of outstanding regional suppliers enabling us to outsource and achieve global coverage.
Artemida Pharma offers comprehensive medical monitoring to ensure the safety of subjects participating in clinical trials. Dr Robert Miller, one of our Managing Partners, can act as an interim Chief Medical Officer (CMO).
We can provide consulting with regard to the design and set up of pharmacovigilance systems as companies move into the marketing phase. Common areas for which we provide support include the use of Drug Safety Monitoring Boards (DSMB) and Safety Evaluation Committees, writing of risk-management plans (RMPs) and preparing for regulatory submission. We can project manage pharmacovigilance systems including provision of a Qualified Person for Pharmacovigilance (QPPV).