We provide the tools and mechanisms to allow any-size CRO or Life Science Consulting group to maintain an audit-ready posture with sponsors and regulatory authorities.
Many of the large CROs or large Life Science consulting firms have well-established IT departments, or even have acquired an IT company, to provide a level of expertise. However, numerous CROs and consultants, who really understand their therapeutic area or clinical areas of excellence, don’t have a mature IT department — or they rely heavily on an IT provider who doesn’t understand the demands of the Life Science world. We provide the tools and mechanisms to allow any-size CRO or Life Science Consulting group to maintain an audit ready posture with their sponsors or the regulatory authorities. We are routinely engaged by the quality teams of our clients to work with them on FDA audits, and we can provide all of the artifacts and necessary SOPs to maintain the qualified and validated state of our customer environments.
We have added 21 CFR Part 11 enhancements to numerous commercial grade tools that provide Voice or Video capabilities previously only found possible by very expensive hardware components. By utilizing existing technologies and adding that regulatory wrapper around these applications we can extend our CRO or LS Consulting clients capabilities without them having to invest in new technologies or expertise.