At PMI, we are proud of our long history of successfully
run clinical studies and proven results on behalf of our satisfied
clients. The following case studies provide a small sample
of studies with which we’ve been involved. If you would
like other examples of the work we've done, or if you have
a unique situation you would like to discuss, please contact
Quality Management and Early Submission
An early-stage company contracted PMI for clinical monitoring
and data management services related to FDA clearance to
market a Class III ophthalmic laser in the U.S. The first
generation version of this technology had been cleared for
the U.S. market 12 months prior - and as the study design
involved 2 year follow-up on 500 patients - the project
needed to move expeditiously in order for the sponsor to
successfully impact the market.
In alignment with the company’s objectives, PMI worked
with the sponsor to accelerate study initiation and patient
enrollment, then conducted regular monitoring visits to
review and collect data for just under 1,000 subject eyes
enrolled at 6 sites. The majority of primary cohort subjects
were enrolled in less than eight months, and subject accountability
at the 6 and 12 month exams was 95%+.
Eighteen months after PMI initiated work on this project,
the company received FDA Ophthalmic Panel recommendation
for PMA approval, and clearance to market came approximately
one year earlier than projected. This could not have been
accomplished without the application of organizational skills,
goal-orientation and thoroughness of the PMI clinical study
Increased Enrollment Rates with PMI Resources
A clinical trial for a pivotal study of a Class III catheter-based
thrombectomy system had been ongoing for a year. The sponsor,
a small, early stage company, was overwhelmed by the administrative
burden of maintaining subject enrollment and follow-up at
21 study sites and contracted PMI to help with increasing
enrollment rates, conducting regular site monitoring visits,
reviewing study data, and interfacing with the company’s
data management organization on queries generated.
Shortly after the contract was initiated, essential study
documentation maintenance was brought under control, subject
follow-up and outstanding query resolution was occurring
on a timely basis, and additional sites were identified,
qualified, and screened. With the implementation of a multi-phase
enrollment and site management strategy - within 9 months
of PMI’s initiation to the project - the study was
expanded to 33 sites and monthly patient enrollment rates
had increased by 20%.
Streamlined Processes and Professional
At PMI we understand that one of the key milestones in
getting your product to market is the delivery of timely
study data throughout the project. Below is a recent example
of how strong team communications and efficient PMI processes
enabled us to meet client requirements in an efficient and
A major international pharmaceutical company contracted
with PMI for a Phase III study of 104 patients and 11 sites.
Through PMI’s pro-active project management, consistent
focus on data quality and accuracy, and persistent review
of areas that could be collapsed – we were able to
lock the database early for the critical Interim analysis.
The sponsor was very pleased, and as a result of our continued
teamwork and excellent communication, the project was ultimately
submitted for final data lock on schedule.
Rescued by Dedicated Data Performance
A major medical device company had recently acquired new
technology undergoing clinical trials. The new owners were
dissatisfied with the performance of the data management
vendor previously involved in the study. They contracted
PMI to rescue the data management process to improve timeliness
and quality of data reporting.
Proceeding without documentation on the study database,
the PMI project team completed a priority review of the
data tables, verified data entry versus Case Report Forms,
confirmed data changes due to queries, and performed data
cleaning. The study data was then imported into a newly
designed and validated database.
The analysis of study data derived from this overhaul gave
the client critical information needed to make go/no-go
decisions associated with risk analysis in their product
Post Market Information Generates Increase
PMI was selected to develop a protocol and conduct a field
study comparing a company’s IV Infusion System to
current technology. The client perceived that their system
offered significant benefits and wanted to publish evidence
comparing bias and precision, ease of use, and practitioner
acceptance to standard-of-care.
After designing the protocol, PMI assisted with site recruitment,
qualification, budget negotiations, and site initiation
visits. During the study, PMI followed up regularly with
site personnel to answer protocol questions, collect data,
and gather observations about the system. Finally, PMI conducted
site closeout interviews and provided the client with resulting
comments, observations and data collected.
Along with providing objective and subjective materials
for analysis and generation of publications, the information
PMI gathered also significantly contributed to improvements
in the client’s system interface and accuracy. Eighteen
months after study completion, the client was exceeding
sales forecast for their system.
Qualifying Product Pricing Strategy
A European company wanted to introduce a medical device
to the US market based on a premium pricing strategy. PMI
was contracted to provide site monitoring, and data capture
During the study PMI found evidence that the product exhibited
significant competitive features; however, issues that could
be detrimental to a successful market introduction were
also uncovered. Based upon the information PMI provided,
the client chose to make several changes in the manufacturing
process and devote more time to customer service training
prior to initiation of a major U.S. product launch.