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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 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: Site recruitment and qualification;
Site training; Patient recruitment; Study monitoring and site
management.
Data Management:
EDC/Paper CRF/IVRS data capture; case report form -CRF- design,
clinical data management plan, database development, data
entry/processing/CRF review/query resolution, data dictionary
processing, data imports/exports, data QA, database lock/transfer,
database maintenance/archival, security procedures.
Biostatistics:
Study design input, sample size/power analysis, protocol development,
randomization schedule development, CRF review, statistical
methodology consultation,statistical analysis plan development,
analysis data set specifications, interim statistical analyses,
customized data listings, final statistical tables/listings/figures,
review/interpretation results, ad-hoc exploratory analysis,
scientific presentations/journal articles/QC of tables, analysis
data sets.
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.
Product
Development Planning: Market Assessments, Corporate
Set-up and Identity, Market Research, Strategic Planning Consultation,
Medical Product Registration.
Product
Commercialization: Tactical Market Assessments,
Market Research, Product Assessments, Product Launch, Product
Marketing, Product Sales.
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