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.

Going forward, OpenCDISC Community will now be known as Pinnacle 21 Community; and OpenCDISC Enterprise will now be known as Pinnacle 21 Enterprise.

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

Pinnacle 21 is pleased to announce that we’ve been awarded a renewed contract to provide software and services in ongoing support of the FDA’s DataFit program.

According to the FDA’s Center for Drug Evaluation and Research (CDER), which made the decision:

Pinnacle 21 is honored to announce that our president and CEO, Max Kanevsky, has been named to the PharmaVOICE 100 Class of 2015.

The PharmaVOICE 100 is an annual list that recognizes the year’s most inspiring people in the life-sciences industry — leaders who have made a significant impact on their peers, their colleagues, their companies and their communities, as well as the industry at large.

When CDISC published Version 1.3 of its ADaM Validation Rules, a lot of you wondered what to make of it.

According to CDISC: “Some checks have been reworded for clarification … [and] 75 new checks have been added to cover rules not previously addressed. [These] additional checks cover the addition of checks for Adverse Events (ADAE) and the ADaM Basic Data Structure for Time-to-Event Analyses (BDS-TTE).”

To paint a clear picture of what all this means, and how the industry should respond, Pinnacle 21 hosted a recent webinar on this topic. The webinar — titled, “ADaM Validation Update from OpenCDISC” — provided an overview of these changes, and shared our experience of the most common issues in ADaM submission data observed across the industry.

The 2015 PharmaSUG Annual Conference, in Orlando, Florida, was an important and telling event. Pinnacle 21 was there, as both a presenter and exhibitor. The event drew more than 600 attendees, who generated a wealth of intriguing questions and discussions over the four-day stretch.

If you attended our programs, or witnessed the buzz of activity around the booths, then you saw what we saw: pharmaceutical software users who were eager to learn more about how to navigate FDA regulatory submissions in the months and years to come.

Pinnacle 21 ran two important programs to try to answer some of our attendees’ biggest concerns:

On March 24, 2015, CDISC published Version 1.3 of its ADaM Validation Rules. The release's main goal was to add new business rules for ADAE (Adverse Events) and BDS-TTE (Time-to-Event Analysis), and, at the same time, clean up some of the checks from the prior release.

But these new rules still don’t provide a complete solution. ADaM validation requires the ability to supplement the ADaM rules with sponsor-specific controlled terminology and value level checks ... and the ability to test those checks with the same software used by the FDA.

Through this webinar, we’ll provide an overview of recent changes and share our experience of the most common issues in ADaM submission data observed across the industry. Our speaker will be Pinnacle 21’s Michael DiGiantomasso. Mike serves on the CDISC’s ADaM Validation sub-team and is a Data Fitness Analyst on the FDA JumpStart project.

For your convenience, we’ll be providing this webinar at two different times.

In this webinar, we will cover:

• Review of all ADaM validation rules and categories
• Overview of datasets recognized by OpenCDISC
• Adding sponsor-specific CT and VLM checks
• Common ADaM issues in submission data
• Rules for the upcoming release of ADaM IG v1.1

Best regards.
OpenCDISC Team

The next meeting of the NJ CDISC Users Group will be held the afternoon of June 17, 2015 at Medidata in NYC.
 
If you are interested in presenting at the meeting, please contact Patricia Majcher by Friday, May 22, 2015.  Presentations should be no more than 20 minutes long (excluding time for Q&A).  Any CDISC-related topic is welcome.  We look forward to hearing from you!
 
Here is the link for online registration; registration closes Friday, June 5:  https://www.survey-expert.com/web/surveyIndex.asp?U=0001005008105033328
Please note that teleconferencing will not be available for this meeting.
 
The final agenda will be posted about 1-2 weeks prior to the meeting, and instructions for attending the meeting will be emailed to registered attendees about 1 week prior to the meeting.