Clinical Research Organization (CRO) Services by Promedica International (PMI)

Promedica International (PMI) established in 1985 is a proven clinical research organization (CRO) with more than 25 years of clinical trial experience focused on projects for medical devices, biotech, pharmaceutical (pharma), alternative medicine, and medical institutions. 51% of PMI projects come from repeat business and 40% of PMI projects come from industry referrals. Clinical research projects have involved: implantable devices; diagnostic and monitoring systems; surgical systems; topically, percutaneously and intravenously administered drugs; drug delivery systems; infant formulas; homeopathic remedies; personal use products and more.

PMI CRO project management expertise extends across PMI's range of therapeutic specialties, including:

PMI’s Project Management Services support phase II-III clinical trials, post-market studies, development of case report forms, medical writing, and statistical analysis.  Each will require successful project management with quantified expectations and clear communications. PMI’s Scope of Work defines PMI and client responsibilities for implementing your project, and a Project Manager is assigned the responsibility for communicating those expectations.   With an average of 21 years in clinical study management, PMI project managers have a background in clinical research requirements, strong analytical abilities, and refined communication skills. Each project manager heads the entire PMI team with an eye on accountability and continuity.  

Clinical Study Management: Successful clinical studies require the collaborative participation and commitment of an extraordinary team of people working to achieve a complex objective over an extended period of time. PMI has successfully managed acute studies as well as studies involving long-term follow-up, representing a wide range of medical specialties and therapeutic areas. PMI delivers professional quality work in a confidential manner, while maintaining diligence to timelines and budgets. The goal is to be your partner in success. 

Clinical Data Management: Effective data management services facilitate efficient access, processing, summarization, and dissemination of data and information. At PMI, data management services incorporate leading-edge technology, 21 CFR Part 11 compliant systems, and experienced clinical data management personnel to support both electronic clinical data capture (EDC) and traditional Case Report Form (CRF) double data-entry applications.

Biostatistics: Clinical studies are performed for a variety of reasons — preliminary evaluation of safety (first in human, dose escalation, etc.), assessments of efficacy (comparisons of dosage levels, comparisons vs. gold standard, etc.), or performance/user preference comparisons versus alternative products or treatments. Regardless of the study objectives, statistical expertise is critical to running a successful trial that will yield valid results. At PMI, statisticians and clinical programmers have experience with trial design and data analysis across a broad range of medical specialties and therapeutic areas. They have been involved in various types of trials, including preliminary, early-phase studies, pivotal studies for regulatory submissions, and post-approval/marketing studies. PMI provides statistical and clinical programming support for each stage of the clinical study process — before, during, and post-study.

Research Compliance and Education: PMI knows that research compliance is the result of a combination of factors: well-designed protocols and data capture forms; appropriate clinical standard operating procedures; effective site training and monitoring; and periodic project audits. In addition to maintaining their own ISO certified Quality Management System, PMI works with you to develop and implement compliance strategies specific to your study and oriented toward the successful clearance of clinical study inspections by regulatory authorities. 

Clinical Product Development Planning: The global healthcare marketplace is constantly changing, which poses challenging strategic questions on a regular basis. Keeping up to date with regulatory issues, market trends, and competitor activity can be the key to success or failure of your medical business venture. PMI leverages worldwide competencies and alliances in regulatory affairs, healthcare technology, and medical market development to provide integrated, impartial, and expert evaluation to support your product development projects. Consulting teams consist of experienced individuals who have varied backgrounds in clinical research, medical market research, market analysis, product management, and sales/marketing - from both the client and ad agency side. Based on the specific needs, a single expert consultant with years of direct industry experience in the specified market area is assigned, or carefully selected research teams are organized for your project.

Product Commercialization: PMI bridges the gap between your clinical study/product registration and product launch activities. PMI's resources provide a high degree of experience and insight that allows them to help clients develop smart strategies and comprehensive programs for Tactical Market Assessments, Market Research, and Product Assessments, as well as Product Launches, Product Marketing, and Product Sales.