Канал: Pinnacle 21

Real World Data: Challenges and Considerations

Real World Data: Challenges and Considerations

Best Practices for Non-CRF Data Management

Best Practices for Non-CRF Data Management

Best Practices for SEND Dataset Quality Control

Best Practices for SEND Dataset Quality Control

New PMDA Validation Rules 4.0 Explained

New PMDA Validation Rules 4.0 Explained

Quality SDTM — the Bridge between Biostats & Medical Writing

Quality SDTM — the Bridge between Biostats & Medical Writing

FDA Validator Rules v1.6 Explained

FDA Validator Rules v1.6 Explained

New PMDA Validation Rules 3 0 Explained

New PMDA Validation Rules 3 0 Explained

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3

Industry Metrics for CDISC Terminology

Industry Metrics for CDISC Terminology

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

Preparing Vaccine Studies for Regulatory Submissions

Preparing Vaccine Studies for Regulatory Submissions

Controlled Terminology Best Practices

Controlled Terminology Best Practices

This is Pinnacle 21

This is Pinnacle 21

Preparing CDISC Submissions for China’s NMPA

Preparing CDISC Submissions for China’s NMPA

针对向中国NMPA递交CDISC数据做准备 (Preparing CDISC Submissions for China's NMPA)

针对向中国NMPA递交CDISC数据做准备 (Preparing CDISC Submissions for China's NMPA)

Exploring Common CDISC ADaM Conformance Findings

Exploring Common CDISC ADaM Conformance Findings

Best Practices for Annotated CRFs

Best Practices for Annotated CRFs

SUPPQUAL Datasets: good, bad and ugly

SUPPQUAL Datasets: good, bad and ugly

How We Improved the SEND Validation Rules

How We Improved the SEND Validation Rules

Confusing Validation Rules Explained

Confusing Validation Rules Explained

PMDA Validation Rule に関する解説

PMDA Validation Rule に関する解説

PMDA's New Validation Rules Explained

PMDA's New Validation Rules Explained

Do's and Don'ts of Define.xml

Do's and Don'ts of Define.xml

What's New in P21 Enterprise 3.4

What's New in P21 Enterprise 3.4

A bit of humor from Mike @ P21 Live Philly 2017

A bit of humor from Mike @ P21 Live Philly 2017

FDA’s New Business Rules Explained

FDA’s New Business Rules Explained

Max Kanevsky's Acceptance Speech for TOPRA Innovation Award

Max Kanevsky's Acceptance Speech for TOPRA Innovation Award

How to Prepare a Study Data Standardization Plan

How to Prepare a Study Data Standardization Plan

PMDA Official Validation Rules

PMDA Official Validation Rules

ADaM Validation Update from OpenCDISC

ADaM Validation Update from OpenCDISC

FDA Finalizes Requirements for Standardized Study Data

FDA Finalizes Requirements for Standardized Study Data

Introducing OpenCDISC Community 2 0

Introducing OpenCDISC Community 2 0

FDA Official Validation Rules for Submission Data

FDA Official Validation Rules for Submission Data

Creating Define.xml 2.0 with OpenCDISC

Creating Define.xml 2.0 with OpenCDISC

Review of CDISC SHARE R1

Review of CDISC SHARE R1