Statistical Programming and Analysis
Statisticians have extensive knowledge and experience regarding statistical analysis methods, vast programming experience, and very good experience in management and use of extremely large clinical and non-clinical databases. They also have experience working both individually and in a team setting and can communicate with researchers, students, technical and non-technical personnel professionally. Experience also includes writing clinical study reports, summary reports for regulatory purposes, scientific and marketing presentations, and peer reviewed publications.
Experience in therapeutic areas
CNS (Schizophrenia, Depression, Alzheimer’s and Vascular Dementia, Neuropathic pain),
Analgesic (acute pain control and chronic pain management),
Women’s health (hormone replacement therapy, acne, transdermal and low estrogen contraceptive medication),
Men’s health (BPH), erectile dysfunction (ED), Cardiovascular (hypertension), Allergy and Asthma,
Vaccines (combos and flu), Anti-infective medication, attention deficit hyperactivity disorder (ADHD),
Urology (overacting bladder and interstitial cystitis), Irritable bowel syndrome and constipation, drug-eluting stents, Non-Hodgkin’s lymphoma, Orthopedic reconstruction devices, bone growth stimulation devices, Sleep disorders, type 1 diabetes mellitus, pediatric studies.
Vsoft Services
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Specific services included in areas of Study Planning, Conduct and Reporting are :
- Provide input into study design, including sample size calculation
- Write statistical method section of the protocol
- Develop Statistical Analysis Plan (SAP), including mock tables & TOC
- Finalize programming specs/guidelines in consultation with programmers
- Generate random codes and process them for supplies
- Perform simulations to finalize the study design
- Perform interim analysis, OR coordinate with an external committee to get the interim analysis done
- Respond to queries from regulators that are statistical in nature
- Review blinded tables & make necessary changes to the analysis plan
- Review all final analysis & output, including QC of break blind
- Write a statistical report to summarize efficacy (or PK/PD) results
- Perform any exploratory analysis after the planned analysis is done