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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