The next meeting of the NJ CDISC User Group will be held on Monday, Feb 27, 2017, 1-5pm at Novartis Pharmaceuticals Corporation, East Hanover campus.
If you are interested in attending this meeting (in-person or online), please register by Friday, Feb 10th.
Register for NJ CDISC User Group
On November 2, Pinnacle 21 was the recipient of the 2016 TOPRA Award for Regulatory Excellence in Innovation. We were excited to be nominated and shortlisted among some incredible competition. We are really thrilled to accept the award this year!
VIDEO: Max Kanevsky's acceptance speech
With the December 17th deadline drawing near, we are happy to announce several important and timely updates to our platform.
The FDA mandate goes into effect in only 80 days, at which point all new submissions will be required in standardized, electronic format. These new Pinnacle 21 tools will help you meet those demands quickly and confidently.
Validate Analysis Results Metadata (ARM)
Analysis Results Metadata provides traceability from results in a statistical display to the data in the analysis datasets. It helps regulatory reviewers understand and reproduce analysis results, which is why both FDA and PMDA are interested in ARM being included in Define.xml. Now you can ensure that your ARM metadata is compliant and ready for submission.
December 17, 2016, is less than five months away.
As we all know by now, studies starting on or after that date must be submitted to the Food & Drug Administration electronically. They must also utilize the most-recent FDA-acknowledged version of data standards.
To support the latter point, FDA is requesting that sponsors submit a Study Data Standardization Plan (SDSP) as part of the IND application.
With time running out quickly, two big questions have taken on a new urgency:
Have you ever wondered how Pinnacle 21 implements rules for ADaM validation? Below is a list of commonly asked questions.
Does Pinnacle 21 implement the validation checks published by CDISC?Yes, Pinnacle 21 rules are an implementation of CDISC validation checks. In fact, P21's Michael DiGiantomasso and Sergiy Sirichenko are both active members of the CDISC ADaM Compliance subteam. Since 2011, the subteam produced 4 versions of CDISC validation checks, with Pinnacle 21 supporting the industry by releasing 7 updates to the open source rule implementations. This close collaboration between Pinnacle 21 developers, ADaM team core members, and representatives from across the industry is what makes it possible to continuously improve rule definitions and implementations.
Why do the message text and rule counts differ?
CDISC check definitions are designed to serve as requirements to machine implementation, "a programmable test, written such that an affirmative response represents a failure of the requirement. This text is intended for use as a requirement specification which could be implemented in a variety of programming languages". P21's rule messages and descriptions, on the other hand, are designed for the end user to help them quickly identify and fix the cause of validation issue.
In late 2014, the FDA announced that, starting December 17, 2016, all new clinical and nonclinical studies must be submitted electronically and contain data in conformance with the standards specified in FDA’s Data Catalog. This is part of an effort to accelerate the regulatory review process.
At the time of this writing, that deadline is only nine months away. So, the big question looms: Are you 100% ready for FDA submission? Because when December 17th comes, any doubt you have may represent a risk of slowing down the review process. More importantly, you’ll be missing out on an opportunity to get your new drug to market faster than ever before.
On November 24th, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published its first official list of validation rules for CDISC SDTM, ADaM and Define.xml. These long awaited rules cover conformance, reviewability and quality requirements, as described in the PMDA Technical Conformance Guide on Electronic Study Data Submissions. The rules will ensure that data conform to the standards and support ease of use and meaningful analysis.
The PMDA agency is asking sponsors to validate their study data before submission — using these published validation rules — and either correct any validation issues or explain why they could not be corrected in the data guide. PMDA has introduced new “Reject” rules, which, if violated, will cause the review to be suspended until issues are corrected. PMDA can also suspend review if explanations for certain issues are not provided.
OpenCDISC has begun a rebranding process. The first step in that process, effective immediately, is that our organization will no longer be using the name “OpenCDISC” for any product, service or event.
Why? After many years of mutual support and understanding, the CDISC organization has asked us to stop using the name “OpenCDISC.”
What does this mean to you? Ultimately, nothing. The staff at Pinnacle 21 will continue to develop our open source software and make it available to all, free of charge. And we will continue to help and support our users as we always have.
Pinnacle 21 is proud to announce the launch of OpenCDISC Enterprise 3.0, which will be available November 2, 2015. This enhanced, comprehensive, web-based application makes it easier than ever to manage standards compliance over the entire study life-cycle.
Now, instead of validating data right before regulatory submission (and unearthing a world of problems), you can manage it from the beginning: controlling your process, mitigating your risk, and reducing your time to market.
“Continuous Compliance” is Pinnacle 21’s proprietary approach for managing and ensuring consistent data from the moment you design the protocol all the way through to FDA and PMDA submission — and OpenCDISC Enterprise 3.0 is the tool that drives it. The result is an intelligent process that:
- Eliminates risk
- Saves time and money
- Achieves faster FDA approval