Statiza Statistical Services

Data | Statistics | Conclude

Our Services

Statiza provides Statistical Services, Regulatory Assistance and Professional Training to Pharmaceutical Industry, Educational Institutes and Researchers. Statiza enables and accelerates your research program by providing statistical advice and training about research methods, experimental design and data analysis for projects.We have experience across a broad range of biostatistics applications in pharmaceutical industry and we offer help with all aspects of data-based research for BA/BE studies, Phase I-IV Clinical Trials and Product Development & Manufacturing. Dealing with complexities of data, statistical understanding and solving problem in robust and practical way are keys to help our clients. We love statistics and wealth of knowledge to share via consulting or professional courses.

  

Bio Statistics Services

•Biostatistics Services for Phase I to IV clinical trials and Registry
•Biostatistics Services for BA/BE Studies
•Biostatistics Services for Product Development and Manufacturing
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Therapeutic Areas

We have core knowledge and experience in following therapeutic areas:• Oncology, CVS, CNS, Gastroenterology, Dermatology,  Ophthalmology, Urology,  Endocrinology ,Tobacco Studies                                 

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Professional Training

We provide training on professional courses which are specifically designed considering in-depth requirements of professionals and Researchers.
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Experties in Biostatistics

We have experience across a broad range of biostatistics applications in pharmaceutical industry and we offer help with all aspects of data-based research for BA/BE studies, Phase I-IV Clinical Trials and Product Development & Manufacturing

Phase I to IV clinical trials and Registry:

CT Design, SAP Development, Statistical Reports and Regulatory Assistance

Professional Training

We deliver training in the form of One off Lecture, Workshops and Whole courses

BA/BE Studies:

Study Design, Sample Size Calculation, Statistical Analysis and Regulatory Consulting

Product Development and Manufacturing

IV-IVC, Stability Extrapolation and • Statistical Quality/Process Control Methods

Biostatistics Services

Biostatistics Services for Phase I to IV clinical trials and Registry:

• Clinical Trail Design
• Statistical inputs in synopsis/protocol
• Sample size calculation
• Randomization schedule generation
• Statistical Analysis Plan (SAP) Development
• SAS Programming and Independent Validation of Tables, Listings and Figures
• Interim Analysis
• Topline Tables and Listings
• Statistical Reports
• Statistical sections of integrated clinical study report (CSR)
• Client representation at regulatory agency meetings
• Statistical regulatory consulting

Biostatistics Services for BA/BE Studies:

• BA/BE Study Design
• Statistical inputs in synopsis/protocol
• Sample size calculation
• Randomization schedule generation
• Pharmacokinetic/Pharmacodynamic Analysis
• Statistical Analysis and Interpretation • Steady State Simulations
• Statistical sections of integrated clinical study report (CSR)
• Client representation at regulatory agency meetings
• Statistical regulatory consulting

Biostatistics Services for Product Development and Manufacturing:

• In-Vitro-In-Vivo Correlation/Relationship
• Dissolution Similarity using Multivariate Techniques
• Stability Extrapolation
• Support product and process development (Quality by Design initiative) by planning experiments (e.g. Design of Experiments, specification design, optimization), tatistical analysis and reporting.
• Statistical Quality/Process Control Methods
• Out of Trend (OOT) Analysis
• Statistical Evaluation for Quality Matrix and Product Quality Review

Professional Training

We provide training on professional courses which are specifically designed considering in-depth requirements of professionals and Researchers.
We also provide tailor made programs towards need of the client.
This can be in the form of
• One-off Lecture
• Workshops
• Whole courses
Please see the Events for upcoming Courses Events

About Us




Statiza enables and accelerates your research program by providing statistical advice and training about research methods, experimental design and data analysis for projects. Statiza provides Statistical Services, Regulatory Assistance and Professional Training to Pharmaceutical Industry, Educational Institutes and Researchers.

Ms. Vaishali Thakkar – Director, Statiza Statistical Services
Ms. Vaishali has completed M.Phil. (Statistics), MSc. (Statistics) and pursuing PhD. (Statistics).

Ms. Vaishali brings in over 15+ years of industry experience in Biostatistics. Her diverse experience is elicited through her career journey within BA/BE, Clinical Trials (Phase I-IV) for NCE, NDDS, ANDA and Dermatology studies. She has also taken up statistical challenges in product development and manufacturing process. She was lastly associated as Head- Biostatistics with Karmic Life Sciences, Ahmedabad, as Manager with Torrent Research Centre, Gandhinagar and as Head Data-management and Biostatistics at Synchron Research Services. She has been visiting lecturer imparting her knowledge to students pursuing MBA and MSc. (IT) for statistical expertise. Ms. Vaishali has been Statistical Consultant (Reviewer) for Indian Journal of Pharmacology. She has been author and part of 05 publications including Indian and International Journals.


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Randomized Controlled Trials

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Introducing Statiza

With 15 years of diverse industry experience in Biostatistics through the career journey within #BA/BE, #Clinical Trials (Phase I-IV), #Registries, #Dermatology studies, #DRC-#Vasoconstriction studies and also provide statistical support in #product development and #manufacturing process, #regulatory query response etc...

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Contact With us

Statiza Statistical Services, Ahmedabad, India

Phone: (+91 999 83 49249 )