Early development for a start-up company
SFL was contacted by a start-up company developing a well-established small-molecule drug in a completely novel indication. The company wanted to run a small, single center, proof-of-concept trial and asked for SFL’s assistance.
Following discussions with the client, and considering the unconventional development path, SFL recommended seeking scientific advice with the competent authority in the country where the trial would be run and which had a long history of expertise in the chosen therapeutic area.
SFL prepared the whole briefing book, slides deck, rehearsal meetings and managed interaction with the competent authority. The scientific advice meeting was attended by SFL, representatives from the company and the principal investigator. The output of the meeting helped the company focus resources on development activities requiring additional input to ensure a successful clinical trial application.
SFL subsequently wrote the entire Investigator’s Brochure and prepared the CTA package for the client. The CTA was accepted by the health authority without major objections allowing the clinical trial to proceed without issue according to project timelines.