Creation of an Investigators Brochure (IB) for a Drug-led Combination Product

MACH32 Inc. is a health technology company that designs and manufactures medical products. MACH32 is currently developing IMSAFE, a drug-delivery system for the treatment of hemorrhage; IMSAFE, delivers a drug called tranexamic acid (TXA) which helps control bleeding caused by traumatic injury including postpartum hemorrhage. MACH32 is compiling scientific literature and data supportive of IMSAFE in an investigators brochure (IB) document. MACH32 would like to collaborate with students to develop an IB for IMSAFE. The IB will be used to support a new drug regulatory submission with the FDA and Health Canada. This will involve several different steps for the students, including: Reviewing MACH32s IMSAFE regulatory strategy for Canada and the United States. Analyzing clinical and non-clinical data. Summarizing published scientific literature relating to the safety and efficacy of TXA. Organizing literature and data summaries within an investigators brochure skeleton.