Ingenuity BioSolutions LLC offers scientific and strategic clinical consulting and medical writing to pharmaceutical and biotechnology companies. We partner with life science companies to develop, implement, and communicate clinical effectiveness and value of their products. Company is based in Colorado and serves clients nationwide. Contact us ([email protected]) to discuss your strategic objectives and how to advance your program. Services include: • Support and management of preclinical and clinical studies, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance and client SOPs. • Develop biomarker hypothesis and guidance in designing clinical trials (ie, validation design, assay endpoint selection, patient selection) • Medical writing: develop or review all critical clinical study documents, including clinical study protocols, project execution plans (PEPs), informed consent forms, reports or other study-related clinical documents. • Facilitate client-initiated research and oversee research milestone requirements to assure progression of protocols and PEPs. • Provide oversight in the identification, evaluation, and selection of CROs and other outside vendors. • Attend local, regional, and national scientific/medical meetings to gain voice on recent data being presented on products and disease states of interest to the client and to interact with Key Opinion Leaders (KOLs). • Collect intelligence through scientific and medical exchange with clinical investigators, medical experts, and KOLs. Provide relevant information to the client in order to impact clinical strategies and improve medical insights. • Provide scientific training for client sales representatives regarding client products and the relevant therapeutics areas. • Provide scientific support for marketing-led initiatives • Professionally represent the client at all times. Adhere to and demonstrate client's core values.