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Statistical Consulting and Planning

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Statistical consulting often plays an instrumental role in clinical research and drug development. Clinical research is dependent on accurate statistical interpretation of the derived numerical data. Often a robust collaboration among clinicians and statisticians plays a central role. This is where we can help.
We are aware of the importance of an experienced Biostatistician in the sphere of Biotechnology, clinical device development and pharmaceutical drug development. Our team has the capability, skill and expertise to work seamlessly on different projects to provide top-quality analyses along with robust statistical solutions for development programs of varying complexities.
Professionals at KnowTechInfo come with hands-on experience in providing exceptional statistical consulting and planning to our clients for these services:

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Research And Planning For Clinical Development Plans Or CDP And Target Product Profiles TPP

Program-Level Statistical Methods For Endpoints With Assessments For Every Development Phase

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In addition to these, our team offers support and services for the following:

Statistical Planning For Supporting Regulatory Applications (Namely ANDAs, NDAs, INDs, BLAs, PLAs, PMA, IMPDs, 505 b(2), 510 (k)

PK/PD Strategy Development For Drug Development

Regulatory Advisory Committee Support, Representation And Preparation

Market Access Statistical Support:

Pharmacy And Therapeutics Committee Reporting And Cost-Benefit Analysis

NICE Commission, EU, Government Insurance Payer Panel Analysis As Well As Reporting

Statistical Representation Along With Regulatory Meeting Support (Pre-NDA, BLA, EOPII, Pre-IND, Type C meetings)

Our Clients

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