Experience

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 (Diabetes, Autism, Cardiology, Oncology, etc.)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. Design and implementation of SAS-based system with an EP90 front-end. EDC via validated Open Clinica hosted internally. 82 international studies in post-operative settings reviewed for global NDA filing.Clinical operations, Vendor operations, SOP review, site analysis/audit, 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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