AyurData is a consulting firm specialized in clinical trial design and analysis with an emphasis on Ayurveda research. The firm aims to promote scientific rigor in Ayurveda research through modern statistical standards and methods. Services include statistical support for student works and active researchers, training programs, and data analysis services. The firm reviewed current clinical research practices and statistical trends to effectively support researchers.

1. CONFIDENTIAL © 2019 AyurData
Balance
Calmness
Serenity
-THE FIRM & THE SERVICES
OFFERED
Kadiroo Jayaraman
Chief Biostatistics Consultant
AyurData

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OUTLINE
• About AyurData
(Mission, Vision, Scope, People behind, Services offered)
• Statistical applications in Ayurveda research

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ABOUT THE FIRM
• AyurData: We are a group of consultants specialized in Design and
Analysis of Clinical Trials with emphasis on trials in Ayurveda Research.
• Mission: To activate the scientific rigour in the conduct of Ayurveda
research by bringing in modern standards and methods.
• Vision: To be of service to all who pursue scientific research, true to our
mission.
• Scope: We like to embrace all research activities connected with life
sciences but the emphasis will be on Ayurveda in its traditional
connotation.

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PEOPLE BEHIND
• Kadiroo Jayaraman, Chief Biostatistics Consultant
• Has a Ph.D. in biostatistics from IARI, New Delhi: Did postdoctoral
studies from University of Georgia, Athens, USA; Worked as Visiting
Scientist in Canada, USA and Finland; Served as Consultant for FAO of
the United Nations and ADB; Put in 35 years of service in research,
teaching and consultancy in biostatistics, Author of two books and
around 45 publications. Guided three Ph.D. students in biostatistics.
Seven years of experience in clinical domain.
• Praveen Venugopal, Biostatistics Consultant
• Has a Master’s degree in statistics from University of Calicut: Did
PGDCA and MBA; Also did Certificate Course in biostatistics from Johns
Hopkins University; Has 20 years of data analysis experience in Animal
Science, Forestry, Marketing, Retail, HR and Accounting Domains.
Served as Senior Data Scientist for www.sparkchief.com

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SERVICES OFFERED
• Statistical support to dissertation works of doctoral students.
• Design and analytical support to active researchers.
• Training programme on statistical methods for researchers in Ayurveda.
• Data Science services for market research and for analyzing hospital
data.

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STATISTICAL APPLICATIONS IN AYURVEDA RESEARCH
Prelude:
• Research in clinical domain is evidence based.
• Clinical research is highly regulated by regulatory bodies both at
international and national levels (FDA, EMEA)
India: Central Drugs Standard Control Organization (CDSCO).
• Clinical research encompasses Good Clinical Practices (GCP)
perpetuated by international agencies like ICH.
• GCP is built on sound ethics and safety concerns (Informed consent,
Monitoring of adverse events, Restricted sample size, DSMB)
• Research has to be objective ensuring blinding, randomization,
replication and local control in the trial design.
• The data has to be structured and formatted (eCRF, SDTM, ADaM
datasets)
• Data analysis and inference should be based on valid statistical
principles.

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STAGES IN CLINICAL RESEARCH
Phase I : Mostly concerned with dose fixing, safety and PK/PD. Sample
size typically around 30 subjects.
Phase 2 : Addresses both safety and efficacy of the drugs. Sample size
around 100 patients with the end result of RP2D.
Phase 3 : Involves comparison of the new drug/practice with standard
drugs/practices using randomized clinical trials with as high as 10000
patients.
Phase 4 : Post marketing studies to detect any adverse signals arising out
of large scale use of the treatment.

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RESEARCH DOCUMENTATION
• Protocol,
• Statistical Analysis Plan,
• Tables, Listings and Figures shells
• Analysis datasets,
• Data cleaning, Database locking
• Statistical analysis
• Clinical study reports.

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PARADIGM SHIFT IN THE RESEARCH METHODOLOGY
• Traditional Fiducial setup (Standard experimental designs, Least squares
analysis, Testing hypotheses, Multiplicity corrections)
• Bayesian methodology (Adaptive designs for sequential trials, Spending
functions and Error control)
• Big data analytics (Knowledge discovery, Visualization, Forecasting)
• Network Meta Analysis (Combining information from multiple trials)
• Real World Evidence (Utilizing external data other than from
experiments)
• Personalized medicine (Adjusting the treatment based on biotypes)

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SUMMARY
Reviewed about AyurData firm
(Mission, Vision, Scope, People behind, Services offered)
Reviewed the current standards and trends in clinical research.
And we look forward to having an effective collaboration with active
researchers in the clinical domain.
Our Promises
1. Capacity building (Training programmes)
2. Quality publications (Statistical support)

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THANK YOU
© 2019 AyurData /CONFIDENTIAL 11
AyurData Team
Our Prayer