PMI has been the CRO of choice for a variety of orthopedic
clinical research projects for clients ranging from industry
leaders to early-stage companies and private practitioners.
The projects we have managed range from single site studies
involving less than 50 subjects followed for several weeks
to large, multi-center projects involving several hundred
subjects followed for several years.
Our involvement typically includes overall project management,
clinical site management and monitoring, data management,
biostatistics and medical writing support for projects involving:
- Hip replacement prosthetic devices
- Degenerative disk disease
- Bone graft substitutes used in trauma, spinal fusion
and joint revision surgery
Procedural Familiarity and Program Efficiencies
Our ISO-certified systems include plans, procedures
and templates that can be readily customized for orthopedic
projects. In addition, our staff is familiar with the terminology,
exams and instrumentation used in orthopedic practices, and
we have a variety of follow-up programs to facilitate patient
retention. We also maintain a network of orthopedic investigators
and hospital-based study sites located throughout the U.S.,
allowing us to provide early-phase, pivotal and post-market
studies for small, medium or large trials. These assets allow
us to rapidly develop comprehensive project plans and quickly
assemble skilled, highly-rated project teams to partner with
our clients for optimal success.
Broad Array of Services
PMI also maintains an extensive network of globally-based
industry resources, which allows us to provide client
services ranging from early stage product development through
clinical trials/product registration and on to commercialization,
as well as to extend our geographic coverage beyond North
America to the European Union and India.
For more details regarding our clinical expertise, please
review our PMI Clinical Project Summary (PDF)
or Contact Us to discuss
your specific project.