Clinical information tends to be more complex, comes from multiple sources in different formats. As a result, clinical data submission has become time-consuming, costly and error-prone. CDISC® (Clinical Data Interchange Standards Consortium) established new data standards to speed up data-review and improve clinical data exchange, storage and archival. Our technology edge combined to our experience in standards implementation allows us to develop tailored CDISC solutions to accelerate your FDA review. Clinovo introduced a new opportunity to learn these recognized clinical data standards!
Clinovo’s new “CDISC Standards: Theory and Application” class is an 8-week training program starting in June 11th, 2013. The TechTrainings are technical hands-on classes for entry-level or experienced clinical trial professionals designed to help them reach the next step in their professional career. The class will be held in Palo Alto at Dentons Offices or remotely.
Taught by Sy Truong, President at Meta-Xceed and author of award-winning papers, this new course will give an overview of CDISC standards: ODM, SDTM, ADaM and Define.XML. Students will learn how to transform legacy data into these clinical standards through real-life examples. Case studies will include data exchange, archival, and electronic submission to regulatory agencies such as the FDA.
Clinovo will continue to offer the “Base Clinical SAS Programming” class to help entry-level programmers prepare the Base SAS certification, as well as the “Advanced Clinical SAS Programming” class to tackle advanced real-world SAS programming challenges. Clinovo offers $50 gift cards for referrals.
More information on the class can be found on clinovo.com/techtrainings.
Olivier Roth launched the TechTrainings by Clinovo in 2012, a series of hands-on courses for clinical trial professionals, leveraging his company’s years of on-field experience and industry expertise. He is the Marketing & Communication Coordinator at Clinovo, a CRO based in Sunnyvale, focused on streamlining clinical trials for life science companies through technology solutions. Olivier helps managing Clinovo’s marketing and communication from marketing strategy to partnership management, lead generation, event planning and new business opportunities. Prior to Clinovo, Olivier was working as a Strategic Marketing Consultant at VivaSante, an international consumer healthcare company based in Paris.
CDISC® (Clinical Data Interchange Standards Consortium) is establishing data standards to speed up data-review and improve clinical data exchange, storage and archival. Today, 60% of FDA submissions are already done in CDISC standards. The FDA is getting more and more involved into CDISC standards, a meaningful signal for the industry. Theresa Mullin, Director of Office of Planning and Informatics within CDER, claimed that “the FDA is committed to using CDISC standards for the foreseeable future”. These data standards are expected to be mandatory by 2016 for every drug submission.
CDISC standards hold the clinical data to a greater level of readability and compliancy in regards to FDA requirements. Carey Smoak, Senior Manager of SAS Programming at Roche Molecular and CDISC Device Team Leader, points out that “a submission without CDISC standards can have a review period twice as long as one under standards”. Indeed, they facilitate the FDA review process since they are known and understood by reviewers.
A 2009 study conducted by Gartner in collaboration with the CDISC organization shows that the overall clinical trial duration is divided by two when using CDISC standards. Thus CDISC standards ultimately speed up time to market.
So if the benefits of using CDISC standards are so obvious, how can we explain that so many sponsor companies are still not adopting them?
Converting legacy data to CDISC standards is expensive
Clinical data standardization is no simple process: It is time consuming and proves to be tedious. However, a few open source CDISC conversion tools have been launched to address this problem. One successful example is the OpenCDSIC validator software, recognized by the FDA and freely available. CDISC Express, Clinovo’s free SAS-based SDTM mapping tool, has been downloaded 600 times.
In the future, standards can be adopted smoothly if the industry works harder at incorporating them earlier in the process. Indeed, the next challenge is to push CDISC standards upfront in the clinical trial process. CDISC experts agree the best timing to implement CDISC standards is the database built.
CDISC standards are still evolving
Standards are still being built and are in constant evolution. The CDISC organization is still releasing new versions of its clinical standards. Sponsors companies are often scared that if they convert their clinical data to a format, it will be obsolete a year later. Clinical trial experts still state however that sponsor companies should shift to CDISC standards as soon as possible.
Companies often lack the internal expertise
In order to be efficiently used and maintained, Carey Smoak points out that “the wiser choice is to hire people with expertise on CDISC standards”. Companies should educate themselves on this topic and exclusively hire experts from CDISC Registered Solutions Providers organizations.
Ale Gicqueau, CEO at Clinovo
On March 7th 2012, Clinovo hosted the third Silicon Valley Biotalks, hosted by SNR Denton in their Palo Alto offices. The event welcomed over 60 professionals from the biotechnology and pharmaceuticals industry. The panel was composed of top-tier CDISC experts:
- John Brega (PharmaStat) CDISC Implementation and eCTD Submissions
- Carey Smoak (Roche Molecular) Senior Manager, SAS Programming and CDISC Device Team Leader
- Dave Borbas (Jazz Pharmaceuticals) Senior Director, Data Management
- Ale Gicqueau (Clinovo) President & CEO
- Carey Smoak made the point that the medical device world is on the move to implement CDISC standards. One has to be aware that the simple fact in putting data in an electronic database is quite new for some medical devices companies. Combination products in which medical device interact with a drug is favorable to the implementation of CDISC standards. Indeed, the medical device world is learning from the experience of the drug industry on CDISC standards.
- John Brega mentioned that 60% of FDA submissions are already done in CDISC standards. He also stated that smaller pharma companies adopt CDISC standards faster. Indeed, a lot of the bigger companies have already developed in-house standards and even though they see the benefits of CDISC standards, it takes money and time to transform their processes and change their habits. On the other hand, smaller players that have no or few standards in place are more prone to start using FDA approved CDISC standards.
- One of the advantages of CDISC standards is that it holds the clinical data to a greater level of readability and compliancy in regards of FDA requirements. A submission without SDTM can have a review period twice as long as one under SDTM standards. CDISC conversion allows submitters to find out problems or discrepancies even before the FDA does, which gives more data consistency and confidence for the FDA submission. It saves time and frustration on both sides.
- Carey Smoak said that the earlier the CDISC standards were utilized, the better. The best timing to implement CDISC standards is the database built. There is a real challenge to push CDISC standards upfront in the clinical trial process. He recommended to hire people with expertise on CDISC standards. One should educate themselves on this hot topic and only hire real experts and approved service providers.
- Dave Borbas mentioned existing CDISC conversion tools, such as the open CDSIC validator software, recognized by the FDA and freely available. He talked about CDISC Express, Clinovo’s free SAS-based SDTM mapping tool. Carey Smoak mentioned the development of new softwares, and that applications on smartphones are also mushrooming, but stated that quality, validation and compliancy were very tricky in this case and an upcoming challenge.
- Dave Borbas said that the FDA is getting more and more involved into CDISC standards. FDA calls it “their” standards now, which is new and great signal to the CDISC community.
Do you want to learn more on CDISC conversion?
Register for free for our next Webinar on March 28th at 9am:
CDISC® SDTM Conversion Made Easy with CDISC Express
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