PMI Blog

Case Studies – Successfully run clinical studies and proven results

by | Aug 14, 2018 | Uncategorized | 0 comments

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 us.

Quality Management and Early Submission Clearance

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 team.

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 Team

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 timely manner.

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 development process.

Post Market Information Generates Increase in Sales

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 services.

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.