A Wide Range of Services to Meet Your Needs
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 three and a half decades working with industry leaders, mid-size and start–up companies, PMI can support your needs with a range of specialized services, including:
Project leadership and accountability; development and maintenance of project-related plans, procedures and logistics; budget/resource allocation management.
Product Development Planning
Clinical Study Management
Clinical investigator brochures; Clinical study protocol documents; “Instructions for Use”; Pre-clinical and clinical study reports; Manuscripts; Posters; PowerPoint presentations; White papers.
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.
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.
Research Compliance & Education
Audits/FDA inspection support; GCP Seminars; Clinical SOP development.