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To serve as an extension of the client's Biometrics (Statistics, Programming, and Clinical Data Management) team providing support equal to or better than what the client would have expected from their own Biometrics staff. To integrate with the client's in-house staff as the supporting team members providing the best Biometrics support measured by. Quality - sustainable for the regulatory submission. Speed - fitting the client’s timeline. Flexibility - like the in-house staff.

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Home | Pharma Data Associates, LLC | pharmadataassociates.com Reviews

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To serve as an extension of the client's Biometrics (Statistics, Programming, and Clinical Data Management) team providing support equal to or better than what the client would have expected from their own Biometrics staff. To integrate with the client's in-house staff as the supporting team members providing the best Biometrics support measured by. Quality - sustainable for the regulatory submission. Speed - fitting the client’s timeline. Flexibility - like the in-house staff.

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Home | Pharma Data Associates, LLC | pharmadataassociates.com Reviews

https://pharmadataassociates.com

To serve as an extension of the client's Biometrics (Statistics, Programming, and Clinical Data Management) team providing support equal to or better than what the client would have expected from their own Biometrics staff. To integrate with the client's in-house staff as the supporting team members providing the best Biometrics support measured by. Quality - sustainable for the regulatory submission. Speed - fitting the client’s timeline. Flexibility - like the in-house staff.

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pharmadataassociates.com

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Home | Pharma Data Associates, LLC

https://www.pharmadataassociates.com/home

To serve as an extension of the client's Biometrics (Statistics, Programming, and Clinical Data Management) team providing support equal to or better than what the client would have expected from their own Biometrics staff. To integrate with the client's in-house staff as the supporting team members providing the best Biometrics support measured by. Quality - sustainable for the regulatory submission. Speed - fitting the client’s timeline. Flexibility - like the in-house staff.

2

Case Studies | Pharma Data Associates, LLC

https://www.pharmadataassociates.com/CaseStudies

Cost Savings as a Result of Sample Size Reduction. Early termination of a phase 2b and extension trials using Bayesian posterior predictive probability - a 50% cost saving. Sample size re-estimation using Bayesian posterior predictive probability - a 30% reduction in trial length. Rescue Mission for an NDA Submission. NDA re-prepared with amended phase 3 CSRs, new ISS, new statistics data package compliant to the FDA eSubmission requirement - all completed in 2 months. Consideration in Study Design.

3

About Us | Pharma Data Associates, LLC

https://www.pharmadataassociates.com/AboutUs

We are a team of statisticians, SAS programmers, and clinical data managers who previously worked in the large and small biopharmaceutical companies or government agencies (including the FDA and NIH Clinical Center). Curriculum Vitae of Our Key Personnel. Manager, Statistical Programming. Principal Clinical Data Manager.

4

Useful Links | Pharma Data Associates, LLC

https://www.pharmadataassociates.com/References

ICH E3 - Structure and Content of Clinical Study Report. ICH E9 - Statistical Principles for Clinical Trials. FDA 2008 Guidance - ISE. Guidance for Industry M4E: The CTD - Efficacy. FDA Guidance - Location of ISS/ISE within CTD. FDA Guidance - Clinical Safety Review of an NDA or BLA. CTD Headings and Hierarchy. FDA Data Standards Resources. FDA CDER (including ICH) Guidances. Clinical Data Interchange Standards Consortium (CDISC). SAS v9.1.3 Online Document. FDA Exposure-Response Design and Analysis.

5

Our Capabilities and Recent Accomplishments | Pharma Data Associates, LLC

https://www.pharmadataassociates.com/Capabilities

Our Capabilities and Recent Accomplishments. Biostatistics Support for Clinical Studies. Provide input on the power/sample size for various study designs. Review CRF design to ensure data collection meets the protocol objective. Assist protocol design and write the statistical section. Support interim analysis and data safety monitoring board. Develop SAP including mock tables for individual studies or ISS/ISE (Integrated Summary of Safety/Integrated Summary of Efficacy). Program in SAS for TLFs. Program...

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pharmadata.ru

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Портал PharmaDATA.ru предоставляет инструменты для всех участников фармацевтического бизнеса:. Увеличение прибыли аптеки без дополнительных финансовых затрат! Доступ к аналитической отчетности и проведению маркетинговых акций. Размещение прайс-листов в системе сравнения цен «ePrica, доступ к аналитическим отчетам. Показатели фармацевтического рынка России за июль 2015 г. (далее…). Количество подключенных к порталу PharmaDATA.ru аптек превысило 12 тысяч! Средняя стоимость упаковки (руб).

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pharmadata.us

PharmaData - About

We build software to identify opportunities and boost profit within pharmacy. PharmaData was founded in 2010 to help pharmacies make sense of their data in real-time. We introduced live data in 2011 as an industry first. Our software is used by more than 7000 pharmacies world wide in multiple languages. PharmaData’s technology helped us achieve one of the largest ROIs I’ve ever seen. Vice President Global Sales. PharmaData helped Alphapharm increase Generic Medicine sales in Australia.

pharmadataassociates.com

Home | Pharma Data Associates, LLC

To serve as an extension of the client's Biometrics (Statistics, Programming, and Clinical Data Management) team providing support equal to or better than what the client would have expected from their own Biometrics staff. To integrate with the client's in-house staff as the supporting team members providing the best Biometrics support measured by. Quality - sustainable for the regulatory submission. Speed - fitting the client’s timeline. Flexibility - like the in-house staff.

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PharmaDates.com | Tracking Important Dates for Pharmaceutical Companies

Tracking Important Dates for Pharmaceutical Companies. New Drug Application – August 11, 2015 at 10:42PM. 8220;new drug application”. As-it-happens update August 12, 2015. Dakota Midday: The Legacy of Dr. Frances Oldham Kelsey. 8230; was the new medical officer at the Food and Drug Administration when she was assigned the review of a new drug application for thalidomide. See more results Edit this alert. You have received this email because you have subscribed to Google Alerts. August 12, 2015. In 2010, ...