At K3-Innovations, we are passionate about delivering exceptional clinical research services to the bio/pharmaceutical and medical device industries. Our highly skilled teams have a proven track record of supporting global clinical trials of all phases and across diverse therapeutic areas for companies of all sizes in the US and around the world. Our commitment is to provide our clients with the highest quality, cost-effective, and timely solutions. We offer a range of services, including: Biostatistics and Programming (submission-ready statistical analysis) SDTM Implementation (compliant with CDISC database, datasets, and documents) Functional Service Provider (FSP) Consulting Services Staffing Services At K3-Innovations, we believe in operating with the utmost integrity and compliance. Our services and systems are governed by well-defined SOPs and policies, and are fully compliant with regulatory requirements such as ICH/GCP, FDA 21 CFR Part 11, and other client-specific standards. This ensures the validity and reliability of study data and programs for statistical outputs. Our mission is to always strive for your satisfaction. We are dedicated to finding the most efficient and cost-effective path to meet your needs, and always act in the best interests of our clients, employees, and communities. Our talented team operates as an extension of your own, providing quick engagement and strategic thinking to bring additional input, insight, and efficiency to every solution.