Muse clinical, quality assurance and compliance services
clinical auditing
Our expertise spans the full range of audit activities, so yours doesn’t have to.
Clients rely on us for audits of investigator sites, specialized and full-service CROs, internal systems, and clinical and support vendors (e.g., IRB, core labs, electronic data capture) . We pride ourselves on the particular expertise we offer in Phase I, oncology, neuroscience, pediatric, vulnerable population and consumer health trials, including actual use studies.
In addition to audit conduct, we are available for full service support of your audit program, from “big picture” activities such as risk-based strategy and process development to the minutiae of daily program management. We can work with you to get the most out of your audit program, using the data generated to effect genuine change and quality improvement.
Whether you are developing a new system from the ground up, or working with an established product to house your TMF, we have the expertise to support each phase of implementation. We’ve worked in support of large-scale TMF system development from specifications gathering and process design through global roll-out, and can guide or contribute to your project at any stage.
Smaller organizations may have more modest needs, but a robust TMF system and process are still within reach. We apply the best practices of large companies to support system and process development on a smaller scale.
Additional services include TMF audits, records management consulting and process development.
trial master file
quality services
Quality assurance activities span more than just audits, and so do we! We are available to either supplement your existing staff or act as part-time staff on an ad hoc basis, expanding your ability to maintain an effective compliance group.
Additional services include full-service SOP development, SOP assessment, gap analysis and risk mitigation planning, and CAPA system development and implementation. We can help you create a robust infrastructure to support the demanding regulatory needs of a successful research program.
Both new and seasoned investigators will benefit from support tailored to help your practice build or improve its processes, and increase overall compliance.
For investigators, we offer process assessments, mock inspections/audits, and procedure development. Additionally, we provide custom training that addresses the reality of each site, providing practical guidance to either get you up to speed with GCP and best practices or take your understanding to the next level.
Sponsors can rely on us to prepare research naïve sites for the challenges of clinical research, with a focus on safety, GCP compliance and generating reliable data.
investigator support
auditor training
While we firmly believe in the value of independent auditing, we also feel that small organizations can leverage the talent they have in-house to increase quality. Coupled with independent audits, training in-house staff to perform quality assessments can be a cost effective approach.
For organizations with an audit group already in place, we develop and deliver training to prepare them for the field, or challenge seasoned auditors to consider a fresh approach.