PHARMA-STATS, A Single Point Statistical Solution Company
Ms. Nirali Mehta, Founder & Director of PHARMA-STATS has more than 14 years of versatile experience as a biostatistician in Bioequivalence studies, Clinical Trials, Dissolution similarity, IVIVC, Stability analysis, SAS programming, CDISC.
PHARMA-STATS works with several pharmaceutical/CRO clients in India, USA & EU region.
- Sample size calculation, Statistical Inputs in Protocol & SAP development
- Statistical SAS Programming, TFLs preparation
- CDISC Migration for BE: Complete project submission
- DSMB-Data Safety Monitoring Board
Single Point Statistical Solution:
- Statistical system implementation & Audit
- SOP development
- Support in regulatory query response
- Review of failed BE study CDISC development for BE: SAS Codes, SOPs, System setup
Biostatistical Training to Pharmaceutical Industry:
- Hands on training to understand fundamental of biostatistics on various areas: Bioequivalence, Clinical trials, Sample size, Study design, advance statistical design, outlier issues, formulation development, dissolution similarity, stability analysis, regulatory aspects
- CDISC Training : Implementation, Regulatory Requirements & Applications in Bioequivalence Studies
Biostatistical Training to Statisticians:
PHARMA-STATS was established with the objective of imparting multi faceted management education while catering to the needs of the emerging Indian pharmaceutical industry.
PHARMA-STATS Ahmedabad started its operations from March 2013 to offer an excellent on-campus learning opportunity that facilitates intensive participation and extensive teamwork through critical thinking and decision making.
As a new generation PHARMA-STATS with its innovative use of case study method, industry visits, Advance modules and classroom sessions strives to attain world class academic standards and nurture leaders of tomorrow.
PHARMA-STATS has been recognized as an esteemed institute in “Pharmaceutical Statistics” in a short span. More than 50 Pharmaceuticals and CROs are shown faith in our training and help us to claim 100% placements. We welcome corporate world and recruiters to visit us and interact with our students.
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- Resume of Biostatisticians