At K3-Innovations, we are dedicated to provide clinical research services to bio/pharmaceutical and medical device industries. Our teams have proven expertise and reputation in supporting global clinical trials of different phases across various therapeutic areas for companies of various sizes in the United States and globally. We are committed to provide our clients with the highest quality, cost effective and timely deliverable. K3-Innovations would like to offer following services to your organization: · Biostatistics and Programming (submission ready statistical analysis) · SDTM Implementation (CDSIC compliant database, datasets and documents) · Functional Service Provider (FSP) · Consulting Services · Staffing Services K3-Innovations’ services and systems are governed by well-defined SOPs, policies and are compliant with regulatory requirements such as ICH/GCP, FDA 21 CFR Part 11 and other client specific standards to ensure compliance with the protocol, SOPs, and regulatory requirements as well as the integrity and validity of study data and programs for statistical outputs. Your satisfaction is our mission. We are committed to advancing the most efficient and cost-effective path to the needs of our clients, and working for the best interests of our clients, employees, and communities. Our dedicated team serves as an extension of your team. We engage quickly and provide strategic thinking, deliver additional input, insight, and efficiency to every step of our solutions.