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Friday, 22 April 2016

Nirali Mehta

Nirali Mehta

Nirali Mehta

Director at PHARMA-STATS & consultant Biostatistician for Bioequivalence services



Director & Consultant Biostatistician

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 ::
:: Pharma-Stats ::





Director & Consultant Biostatistician for Clinical services

– Present (3 years 2 months)Ahmedabad Area, India
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.
PHARMA-STATS; A Corporate Training Center
PHARMA-STATS; A Corporate Training Center
PHARMA-STATS Activity & Performance Report on first Birthday
PHARMA-STATS Activity & Performance Report on first Birthday
Biostatistician Placements
Biostatistician Placements


Torrent Pharmaceuticals Ltd
(7 years 8 months)Gandhinagar, Bhat
Looking after Bioequivalence , Clinical Trials, SAS programming, IVIVC

Medical Statistician- Clinical Research

(1 year)

Research Associate

SAL Hospital
(4 months)

Volunteer Bio-Statistician

Gujarat Cancer & Research Institute
(1 year 2 months)

Research Associate

Sterling Hospital
(4 months)

Visiting Lecturer

St. Xavier College
(7 months)


SAS programming




School of sciences, Gujarat University

Doctor of Philosophy (Ph.D.), Statistics, First
Pharmaceutical statistics

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

    BirthdayFebruary 26
  • Advice for Contacting Nirali




    Kristīne Krūkle-Bērziņa

    Kristīne Krūkle-Bērziņa

    Kristīne Krūkle-Bērziņa



    University of Latvia
     – Present (1 year 8 months)

    PhD student

    University of Latvia
     –  (3 years)


    Latvijas Universitate

    Doctor of Chemistry at Latvijas Universitate, Physical and Pharmaceutical Chemistry
    The relative stability of xylazine hydrochloride polymorphous forms
    A Bērziņš, K Krūkle, A Actiņš, JP Kreišmanis
    Pharmaceutical development and technology 15 (2), 217-222
    The Preparation and Characterization of New Antazoline Salts with Dicarboxylic Acids
    A Dravniece, A Actiņš, K Krūkle-Bērziņa, I Sarceviča
    Molecular Crystals and Liquid Crystals 606 (1), 154-164
    Powder X‐Ray Diffraction Investigation of Xylazine Hydrochloride Solid Phase Transformation Kinetics
    K Krūkle‐Bērziņa, A Actiņš
    International Journal of Chemical Kinetics 46 (3), 161-168
    A new methodology for the simulation of solid state phase transition kinetics by combination of nucleation and nuclei growth processes
    K Krūkle-Bērziņa, A Actiņš, A Bērziņš
    Journal of mathematical chemistry 50 (8), 2120-2129
    Investigation of the phase transitions occurring during and after the dehydration of xylazine hydrochloride monohydrate
    K Krūkle-Bērziņa, A Actiņš
    International journal of pharmaceutics 469 (1), 40-49
    Hydration of Xylazine Hydrochloride Polymorphic Forms A, Z and M
    K Krukle-Berzina, A Actins, A Berzins
    Latvian Journal of Chemistry 50 (1-2), 73
    The effect of excipients on the stability and phase transition rate of xylazine hydrochloride and zopiclone
    K Krūkle-Bērziņa, A Actiņš
    Journal of pharmaceutical and biomedical analysis 107, 168-174
    Characterization and Physicochemical Evaluation of Molecular Complexes Formed Between Umifenovir and Dicarboxylic Acids
    A Kons, A Bērziņš, K Krūkle-Bērziņa, A Actiņš
    Latvian Journal of Chemistry 52 (1-2), 28-40
    Poster Presentation
    K Krūkle-Bērziņa, A Actiņš
    Acta Cryst 70, C1704
    Nanostructuring approach in developing polymer membranes for advanced energy conversion devices
    G Vaivars, E Āboltiņa, M Markus, K Krūkle-Bērziņa, A Actiņš, A Zicmanis