Indications and Example Projects:

Our customized clinical research services have been utilized in a broad range of indications across all aspects of the regulatory approval process. In addition to the full scope of services, below are some examples of projects that we have completed.

Clinical OperationsVaccine/Drug trials Regulatory ConsultingCRF Design
Multiple trials at many sites: Neurology, Diabetes, Autism, Cardiology, Oncology, Rare Diseases (RETT syndrome, Fragile X, others)HIV, Hepatitis C.Review IND, CSR, and NDA submissions.Phase I - III studies of gastrointestinal, urinary, diabetis, cardiology, and anesthetic drugs.
Database IntegrationData Entry SoftwareStatistical Analysis Plan ReviewVendor Audits
Existing studies (spreadsheets, ascii files, and paper CRF’s) and planned studies integrated into integrated safety (ISS) and efficacy (ISE) SAS datasets for NDA filing. IBM Clinical Development (formerly Merge ECOS or MyEDC. VSI was a charter member assisting with the platform design.)82 international studies in post-operative settings reviewed for global NDA filing.Vendor qualification, Computer systems validation, privacy, SOP review and gap analysis, site audit (including "for cause"), clinical operations, data management, and statistics.
Presentation Preparation for Professional AssociationsCustom SAS ProgrammingCoding of Medical TermsValidation / Hazard Plan
These include: The American Urological Association, Royal Academy of Science, American Public Health Association, and European Congress of Allergology & Clinical Immunology. Data integration, client presentations. Migration of legacy data to MedDRA and WHO drug dictionary.Assessment, remediation, testing and implementation.



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