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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.

In the Beginning

It was late 2007. Mad Men was the hottest show on TV. The BlackBerry was still the most popular smartphone. Senator Barack Obama was securing his party’s nomination for the next presidential election. And a young clinical data exchange specialist named Max Kanevsky was contemplating the future of the biopharmaceutical industry.

During his tenure at Merck, Max had been responsible for integrating the company with many external partners (e.g., laboratories, CROs, joint ventures, technology providers), working with many non-standardized sources of data. Though the norm, gathering all that disparate data and mapping it into Merck’s internal standard was a huge challenge. When the Clinical Data Interchange Standards Consortium (CDISC) started to make headway in its mission to develop a global set of standards, it marked a new beginning. CDISC would eventually define the standards for the entire industry.

But Max wondered how sponsors would possibly manage such a sea-change. At the time, software options to help ensure a submission’s compliance with FDA business rules were limited. WebSDM offered limited performance and capabilities, at a price point that was prohibitive to many. Meanwhile, Max was helping Merck with its early manual implementations of CDISC standards, including LAB, ODM and SDTM, which were difficult and time consuming. And each new challenge provided an obstacle that could threaten FDA approval of any given drug. There had to be a better way. But what?

On March 24, 2015, CDISC published Version 1.3 of its ADaM Validation Rules.

So, what’s changed?

In the simplest terms: the release’s biggest enhancement is the ability to recognize and validate ADAE (Adverse Event Analysis) and BDS-TTE (Time-to-Event Analysis) datasets. CDISC has added 75 new rules in total, and, at the same time, cleaned up some of the checks from the prior release to ensure that their failure criteria is machine-testable.

So, what should concern you?

These published business rules conform to the definition of CDISC’s intention that each rule requirement be broken down into its constituent parts and should be machine-testable. For example, a simple rule which states “C BETWEEN A and B” will be stated as C >= A and C<=B. This normalized model works for business requirement capture … but it can make implementation, testing and human understanding more complicated than they need to be.

Beyond that, these newly enhanced ADaM validation rules still don’t provide a complete solution. Since ADaM IG v1.0, CDISC has been providing mere specifications documents. ADaM validation requires more than that. You need the ability to supplement the ADaM rules with sponsor-specific checks, especially for sponsor defined controlled terminology and value level metadata. And you need to be able to test those checks with the same software used by the FDA.

It was a long time coming. But, finally, on December 17, 2014, the FDA announced that applications must be submitted electronically, and that submissions will be required to contain study data in conformance with CDISC standards.

The industry has been given 24 months from the publication of the final guidance documents to comply. Not wanting to waste any precious time, Pinnacle 21 hosted two webinars — on January 7th and 8th, 2015 — to help guide you through the new processes.

We are proud to announce the release of our next generation open source toolkit. Community 2.0 was created just for the CDISC professional and provides a wealth of game-changing new tools, including an upgraded version of Validator, a Define.xml Generator, and more. Download OpenCDISC Community 2.0 here

OpenCDISC Community 2.0 includes the following new features:

• Validator – upgraded with FDA validation rules and ability to validate against study specific value level metadata
• Define.xml Generator – creates fully compliant Define.xml 2.0 for SDTM, SEND, and ADaM datasets
• Data Converter – quickly converts data between SAS XPORT, Dataset-XML, Excel, and CSV formats
• ClinicalTrials.gov​ Miner – aggregates clinical outcome measures/endpoints across trials and therapeutic areas

This morning, November 18th, the Food and Drug Administration (FDA) published its first official list of validation rules for CDISC SDTM. These long awaited rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis.

The FDA 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 Study Data Reviewer's Guide. This recommended pre-submission validation step is intended to minimize the presence of validation issues at the time of submission.

Rest assured: we have implemented the new FDA validation rules in the upcoming OpenCDISC Community 2.0 — keeping you ahead of the curve. Please join Sergiy Sirichenko — co-founder of OpenCDISC and an FDA Data Fitness Analyst — to learn about the new FDA validation rules and how you can get compliant in time for your next submission.

On October 9, 2014, the Pinnacle 21 tour bus rolled over the Golden Gate Bridge and into Foster City, where we held our third OpenCDISC Live event. And what an event it was.

We kicked off with a brief history of OpenCDISC, where Max Kanevsky, Pinnacle 21 president and CEO, talked about the origins of the project and how it has evolved over years. Attendees then received tutorials on two FDA programs — JumpStart and DataFit — and learned why both are so critical to the modern FDA review process.

The second stop on the OpenCDISC Live 2014 Tour, in East Hanover, NJ, was a lively and engaging event, and we thank everyone who attended.

In addition to providing tutorials on two FDA programs — JumpStart and DataFit — our subject matter experts covered how to create FDA-compliant Define.xml 2.0 files. Attendees also got a sneak peek of OpenCDISC Community v2.0, the next-generation of our gold-standard open-source software.

OpenCDISC Live is making its way to the San Francisco Bay Area for the West Coast swing of our 2014 tour!
Enjoy this opportunity to meet the creators of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first West Coast Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes.
We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist
the process.