Promedica





 

 
    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 


At PMI, we have successfully serviced a variety of clinical projects over a wide range of medical specialties and therapeutic areas. With a track record of more than two decades working with industry leaders, mid-size and start–up companies, PMI can support your needs with a range of specialized clinical study services, including:

Project Management: Project leadership and accountability; development and maintenance of project-related plans, procedures and logistics; budget/resource allocation management.

Clinical Study Management Services: Site recruitment and qualification; Site training; Patient recruitment; Study monitoring and site management.

Data Management/Biostatistics: Data management plan development/review; EDC/Paper CRF/OCR/IVRS data capture; CRF design; Database development and validation; Automated accuracy/logic checks of entered data; Secondary data review; Data coding and quality assurance; Standard/customized reports; Biostatistics.

Medical Writing: Clinical investigator brochures; Clinical study protocol documents; “Instructions for Use” ; Pre-clinical and clinical study reports; Manuscripts; Posters; PowerPoint presentations; White papers.

Research Compliance & Education: Audits/FDA inspection support; GCP Seminars; Clinical SOP development.

Strategic Services: Market research; Market assessments; Strategic planning consultation; Marketing study management; Medical product registration.

 


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