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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 Operations | Vaccine/Drug trials | Regulatory Consulting | CRF 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 Integration | Data Entry Software | Statistical Analysis Plan Review | Vendor 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 Associations | Custom SAS Programming | Coding of Medical Terms | Validation / 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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