Our enterprise-wide functional solutions provide talent, process improvement, technical expertise and a deep understanding of functional outsourcing models.
With ICON’s flexible Functional Solutions, you can focus on core competencies while a team of project management and therapeutic experts deliver the fit-for-purpose results you need.
Our Functional Solutions can include customer or CRO SOPs, EDC (and other) systems, on and off shore resourcing solutions and all aspects of a CRO infrastructure. We provide rigorous implementation and adherence to a set of agreed-upon standards, so you can obtain results that align seamlessly with your research needs.
We provide Functional Solutions in the following areas:
- Clinical Data Management - by using proven processes, such as in-stream validation and continuous data cleaning, we provide real time access to post processed datasets, and analysis dataset feeds on an automated schedule, while minimising time-to-market. In addition to possessing industry certifications from SAS-developed training classes, members of our coding team have between 10-15 average years of experience.
- Statistics and Programming - we provide upfront planning and support by sharing our statistical expertise, whether its innovative clinical trial designs, statistical analyses, or regulatory support.
- Drug Safety - from our six global safety hubs, we provide a full range of services spanning the entire development lifecycle, including compiling a concise safety profile of your product, and developing a comprehensive risk management plan to get you safely through the approval process.
- Medical Writing - we provide a complete writing service, spanning the generation of individual documents to extensive medical writing programs. Each project is assigned a dedicated medical writer who is responsible for managing the writing process and a communication plan is agreed with the sponsor.