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Service
Data Management
Vsoft offers data management consulting with expertise in clinical data management, DSMB,NDA submissions and data standards implementation. Services includetechnical and management expertise to lead the data management function within a therapeutic area or provide technical expertise in data acquisition.
SAS Consulting
Vsoft specializes in providing SAS consultants from entry level to the senior management. Consultants are provided in-house and SAS institute training to update them with the latest SAS technology. With emphasis on reliability and web enablement, consultants are geared to provide customers with the tools required to enhance growth.
Vsoft offers SAS consulting services with extensive experience in Clinical programming across all therapeutic areas and phases of drug and device clinical trials. Vast experience in CDISC implementation and Dictionary Coding has enabled Vsoft to offer specialized services in SAS consulting.
Medical Affairs Consulting
Vsoft offers services associated with safety reporting, such as dictionary coding for adverse event, medical history and concomitant medication using standard dictionaries like MedDRA and WHO Drug. Experienced staff in this area can help in reconciling serious adverse events and non-serious adverse events for periodic reporting at Data Safety Monitoring Boards (DSMB). Services include participation in IRBs and conducting periodic monitoring visits.
Training
Vsoft provides training in Data Management, SAS Programming, Systems Validation and Statistical Analysis for Clinical Trials. The syllabus is geared to provide required skills to employees and enable them to work stress-free. The training is conducted at corporate headquarters at 33 Wood Avenue South, Iselin, New Jersey. These courses are offered to corporate clients only. Pre-qualification or prior experience is not required, but elementary knowledge in the professional area will be helpful. Courses are conducted by professionals that are qualified, certified and experienced.
Web Enablement Services
Web enable services is radically changing our ecosystem
Web Enablement consists of closely coordinating clinical trial activities among various entities such as Biostatistics, Clinical Packaging, Medical Investigators (located worldwide), Clinical Data Management, Medical Writing and FDA
Resourcing
Right people for right job with real world experience
Resourcing is a process of finding and providing right candidates to companies who are in urgent need of personnel to assign them on projects they are undertaking. Vsoft does resourcing for Pharmaceutical and Financial majors, providing them with very reliable and efficient resources, at the right time.
Statistical Analysis
With over 25 years of statistical analysis, mathematical modeling and computer science experience in various areas of interest, Statisticians have prior experiences in NDA clinical trials (protocol development, writing statistical analysis plans, performing statistical analysis and writing statistical analysis reports, regulatory submissions at FDA and International: Europe and Japan) and clinical study reports, meta-analysis, integrated safety and efficacy analyses and final reports, new drug strategic development plan, publications and marketing support, extensive work in cancer research (prostate cancer and breast cancer), statistical analysis work for Medicaid, Medicare and claims data, research work and statistical analysis on large datasets from NIH, ACS, and CDC, methodological and collaborative research in statistics. Our Statisticians have decades of experience in pharmaceutical industry in several therapeutic areas.