Nirali Mehta
Director at PHARMA-STATS & consultant Biostatistician for Bioequivalence services
LINKS
- Founder/CEO/Owner at PHARMA-STATSPast: Torrent Pharmaceuticals and Wockhardt
Studied Statistics at M G Science College
Summary
Director & Consultant Biostatistician
www.pharma-stats.in
A professional consultant biostatistician having depth knowledge of Biostatistics with an exposure to epidemiology, cardiology, neurological studies, pre-clinical data sets, case-control studies, hospital based patient data, Pharmacokinetic, Pharmacodynamic, Pharmacovigilance-Risk assessment, Stability analysis, handling of patent issues, QbD, DOE, IVIVC, Bioavailability & Bioequivalence(reference scaled, replicate design, re-dosing) Studies and Phase I to Phase IV Clinical Trials.
Expertise in providing inputs on study design (SAP), sample size, randomization, statistical write up (protocol, report, results interpretation), missing data and outlier considerations, interim analysis, post study evaluation, SAS programming & validation, Regulatory audits & Query response (USFDA, France, Austria, ANVISA, CANADA), data monitoring on site, Time management & strategy planning, team co-ordination, etc. Involved in software validation, preparation of SOPs.
Specialties: Solution provider of Pharmacokinetics & Bioequivalence issues related to pilot and pivotal studies, regulatory queries, formulation development (dissolution data, IVIVC, study design) as per the complexity of the molecule.
Trainer: Provides statistical training to non-statistician working in clinical research, quality assurance, formulation development, project management, regulatory affairs. Conducting workshop as well as providing training to employees.
www.pharma-stats.in
A professional consultant biostatistician having depth knowledge of Biostatistics with an exposure to epidemiology, cardiology, neurological studies, pre-clinical data sets, case-control studies, hospital based patient data, Pharmacokinetic, Pharmacodynamic, Pharmacovigilance-Risk assessment, Stability analysis, handling of patent issues, QbD, DOE, IVIVC, Bioavailability & Bioequivalence(reference scaled, replicate design, re-dosing) Studies and Phase I to Phase IV Clinical Trials.
Expertise in providing inputs on study design (SAP), sample size, randomization, statistical write up (protocol, report, results interpretation), missing data and outlier considerations, interim analysis, post study evaluation, SAS programming & validation, Regulatory audits & Query response (USFDA, France, Austria, ANVISA, CANADA), data monitoring on site, Time management & strategy planning, team co-ordination, etc. Involved in software validation, preparation of SOPs.
Specialties: Solution provider of Pharmacokinetics & Bioequivalence issues related to pilot and pivotal studies, regulatory queries, formulation development (dissolution data, IVIVC, study design) as per the complexity of the molecule.
Trainer: Provides statistical training to non-statistician working in clinical research, quality assurance, formulation development, project management, regulatory affairs. Conducting workshop as well as providing training to employees.
:: Pharma-Stats ::
Experience
Director & Consultant Biostatistician for Clinical services
PHARMA-STATS
PHARMA-STATS : Consultancy-Training-Placements
Single point statistical solution for Bioequivalence clinical/pre-clinical studies.
Large experience in Biometrics. There are many roles we can play and tasks we can contribute to, depending on the needs, experience and availability of your Biometrics staff.
-Post study statistical evaluation. It helps manufacturer to better understand their formulations, statistical causes behind the failure of study.
-Gives accurate statistical solution at planning stage of study design based on previous studies evaluation to get successive results.
-analysis clinical/pre-clinical data
-Protocol preparation
-Report Review
-Sponsor/Regulatory query response
-Expert advice on any query regarding guidelines discussion & submission
-Consultant Biostatistician for Data Safety & Monitor Board (DSMB) / Ethic committee
PHARMA-STATS is introducing a new concept in training of Pharmaceutical statistics.
-Training as per client requirements to their non-statistician employees working in clinical research, quality assurance, regulatory affairs, formulation development, project management & IVIVC for better understanding of clinical studies (BE) from statistical point of view.
Training to statisticians in specific areas of Bioequivalence, Clinical Trial (phase III/IV/PMS), Pharmacovigilance and introduction of SAS and other kinetic tools.
-Candidates are also enpored to pharmaceutical requirements with hands on approach. We statisticians to read and interpret clinical and statistical data and results.
-PHARMA-STATS help evaluate a candidate strengths and trains them based on the skill sets leading to long term stability.
Placement of skilled manpower based on requirement specified for Biostatistician needed for Pharmaceuticals & CROs.
Single point statistical solution for Bioequivalence clinical/pre-clinical studies.
Large experience in Biometrics. There are many roles we can play and tasks we can contribute to, depending on the needs, experience and availability of your Biometrics staff.
-Post study statistical evaluation. It helps manufacturer to better understand their formulations, statistical causes behind the failure of study.
-Gives accurate statistical solution at planning stage of study design based on previous studies evaluation to get successive results.
-analysis clinical/pre-clinical data
-Protocol preparation
-Report Review
-Sponsor/Regulatory query response
-Expert advice on any query regarding guidelines discussion & submission
-Consultant Biostatistician for Data Safety & Monitor Board (DSMB) / Ethic committee
PHARMA-STATS is introducing a new concept in training of Pharmaceutical statistics.
-Training as per client requirements to their non-statistician employees working in clinical research, quality assurance, regulatory affairs, formulation development, project management & IVIVC for better understanding of clinical studies (BE) from statistical point of view.
Training to statisticians in specific areas of Bioequivalence, Clinical Trial (phase III/IV/PMS), Pharmacovigilance and introduction of SAS and other kinetic tools.
-Candidates are also enpored to pharmaceutical requirements with hands on approach. We statisticians to read and interpret clinical and statistical data and results.
-PHARMA-STATS help evaluate a candidate strengths and trains them based on the skill sets leading to long term stability.
Placement of skilled manpower based on requirement specified for Biostatistician needed for Pharmaceuticals & CROs.
PHARMA-STATS; A Corporate Training Center
:: PHARMA-STATS ::
PHARMA-STATS Activity & Performance Report on first Birthday
Biostatistician Placements
Bio-statistician
Torrent Pharmaceuticals Ltd
Looking after Bioequivalence , Clinical Trials, SAS programming, IVIVC
Medical Statistician- Clinical Research
Wockhardt
Research Associate
SAL Hospital
Volunteer Bio-Statistician
Gujarat Cancer & Research Institute
Research Associate
Sterling Hospital
Visiting Lecturer
St. Xavier College
Certifications
Education
School of sciences, Gujarat University
Doctor of Philosophy (Ph.D.), Statistics, First
Pharmaceutical statistics
Activities and Societies: Stood 1st in State level (Gujarat) Ph.D paper presentation competition - Science Excellent 2014
Prakash, Nav Chetan, M.G.Science Inst., School of Sciences
Master of Philosophy (M.Phil.), Master in Science(M.Sc.) with statistics, Biostatistics, Medical Research
Additional Info
Interests
Personal Details
| Birthday | February 26 |
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Advice for Contacting Nirali
www.pharma-stats.in
info@pharma-stats.in
info@pharma-stats.in
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