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Vital Experience

Advance Science, Improve Life

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: 

Our staff has been involved in studies for: Rett Syndrome, Autism, OCD, Fragile X, Oncology, Pain (Post-Operative, Oncological, and Neurological), Diabetes (control, diagnostics, delivery, and neuropathy), Allergy (relief and diagnostics), Gastrointestinal, Prostate, Sexual Dysfunction, Traumatic Brain Injury (mild and acute), Cardiovascular, Eye (Retinopathy), Dermatology, Anesthesia, Surgical techniques, Vaccines / Immunology, HIV, HCV, and Specialized Devices.

Countries Served: 

Data has been collected from around the world. Countries include are: Australia, Austria, Belgium, Canada, Chile, China, France, Germany, India, Japan, Romania, United Kingdom, United States.

Regulatory Consulting: 

Review IND, CSR, and NDA submissions. Assisted with FDA meeting and other interactions.

CRF Design: 

Paper and Electronic capture, Phase I-III studies and Device trials.

Database Integration:

Existing legacy studies (spreadsheets, ascii files, and paper CRF’s) and planned studies integrated into integrated safety (ISS) and efficacy (ISE) SAS datasets for NDA filing.

Data Entry Software:

We have a long-standing relationship with the producers of IBM Clinical Development, which accelerates EDC deployment for data and document processing.

Statistical Analysis Plan Review:

82 international studies in post-operative settings reviewed for global NDA filing.

Vendor Audits:

Vendor qualification (patient recruitment and retention, and clinical laboratories), Computer systems validation, privacy, SOP review and gap analysis, site audit (including "for cause"), clinical operations, data management, and statistics.

Clinical Presentation Preparation for Professional Associations:

These include: The American Urological Association, Royal Academy of Science, American Public Health Association, and European Congress of Allergology & Clinical Immunology.

Custom SAS Programming /Drug trials:

Data integration, client presentations.

Coding of Medical Terms:

Migration of legacy data to MedDRA and WHO drug dictionary.

CRF Validation / Hazard Plan:

Assessment, remediation, testing and implementation.

Contacts

Email: info@vtlsys.com
Phone: (847) 458-2900 
Fax:  (847) 241-0116