45:31
Real World Data: Challenges and Considerations
58:01
Best Practices for Non-CRF Data Management
43:31
Best Practices for SEND Dataset Quality Control
25:25
New PMDA Validation Rules 4.0 Explained
30:51
Quality SDTM — the Bridge between Biostats & Medical Writing
25:54
FDA Validator Rules v1.6 Explained
45:22
New PMDA Validation Rules 3 0 Explained
44:02
Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3
47:51
Industry Metrics for CDISC Terminology
43:24
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?
44:19
Preparing Vaccine Studies for Regulatory Submissions
44:34
Controlled Terminology Best Practices
01:57
This is Pinnacle 21
45:21
Preparing CDISC Submissions for China’s NMPA
33:51
针对向中国NMPA递交CDISC数据做准备 (Preparing CDISC Submissions for China's NMPA)
41:39
Exploring Common CDISC ADaM Conformance Findings
41:24
Best Practices for Annotated CRFs
52:54
SUPPQUAL Datasets: good, bad and ugly
39:13
How We Improved the SEND Validation Rules
59:05
Confusing Validation Rules Explained
48:25
PMDA Validation Rule に関する解説
47:29
PMDA's New Validation Rules Explained
41:33
Do's and Don'ts of Define.xml
46:23
What's New in P21 Enterprise 3.4
01:59
A bit of humor from Mike @ P21 Live Philly 2017
01:00:54
FDA’s New Business Rules Explained
01:25
Max Kanevsky's Acceptance Speech for TOPRA Innovation Award
01:02:23
How to Prepare a Study Data Standardization Plan
01:03:11
PMDA Official Validation Rules
57:34
ADaM Validation Update from OpenCDISC
01:04:30
FDA Finalizes Requirements for Standardized Study Data
01:03:26
Introducing OpenCDISC Community 2 0
01:00:45
FDA Official Validation Rules for Submission Data
59:40
Creating Define.xml 2.0 with OpenCDISC
08:09
Review of CDISC SHARE R1
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About
Global leader in software for life sciences companies and health authorities
Pinnacle 21’s Enterprise software for clinical trial data is adopted by the US FDA and Japan’s PMDA, as well as 22 of 25 top biopharma.
Our cloud platform validates data quality and compliance with CDISC standards. It enables a clean data pipeline from Data Management and Biostatistics teams worldwide to health authorities such as the FDA, PMDA and NMPA.
Cleaner data drives informed decision-making. And streamlined approvals bring life-saving medicines to patients faster.
Great Place To Work-Certified™ & Fortune Best Small & Medium Workplaces™, 2019-2021
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