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Archive for the ‘Outsourcing’ Category
Today’s blog features a guest posting by Dr. Shannon Strom, Senior Regulatory Specialist at Cato Research.
Acceptance of electronic submissions by small to mid-size early-stage pharmaceutical companies has been characterized by a slow, but steady, conversion to the eCTD standard, and nowhere is that fact more evident than in the rate of IND conversions to eCTD format. According to the FDA, 52% of original marketing applications and 83% of efficacy supplements are received in eCTD format, but only 12% of original IND submissions are in eCTD format. However, the FDA’s numbers also offer positive signs for the future. While the percentage of original INDs submitted in eCTD format remained stable from FY 2008 to FY 2009, the number of IND amendments in eCTD format nearly doubled, indicating that companies are beginning to understand the benefits of electronic submissions.
Small to mid-size pharma companies most frequently cite infrastructure requirements as the reason to delay conversion to electronic submissions. For a small or early?stage organization with limited budgets and internal resources, the expense of purchasing electronic submission software, including the implementation and validation effort, can be overwhelming enough to wait until the FDA or other global regulatory authorities require electronic-only submissions. After the software is purchased, installed, and validated, a company must also make another investment in hiring a regulatory submission specialist with experience in electronic submissions or providing training to existing regulatory affairs resources to actually create and review the electronic submissions. Additional infrastructure considerations may include implementation of an electronic document management system, on-going validation requirements for software updates, implementation of standardized document templates, and training of medical authors to write for electronic submissions. It’s no wonder why electronic submissions can be so easily delayed by corporate management until strong convincing data justifies the investment.
But this “wait-and-see” type attitude ignores the very real benefits of electronic submissions for small firms. The FDA has stated repeatedly that the eCTD is their preferred format for both INDs and marketing applications, and that the review process is significantly facilitated by the automatic processing of sequences through the Electronic Submission Gateway. Large pharma companies have, for the most part, already made the transition to, or are actively engaged in, the transition process to electronic submissions. A product portfolio that already contains an electronic regulatory submission can be more attractive to a large pharma company than a paper-based regulatory dossier because the time and effort to convert the submission to electronic format is saved. Therefore, it’s within a smaller company’s best interest to develop electronic dossiers as soon as possible.
Software providers have developed very cost- and time-effective solutions to minimize the impact of electronic submissions on existing corporate infrastructure and business goals. The best solution for some companies may be to outsource some, if not all, of the components of the electronic submission process. One of the more innovative solutions in the last few years has been to utilize Software as a Service. In this business model, the submission software is “rented” as a hosted solution from the software vendor to minimize the internal infrastructure requirements and the validation effort and to maximize the time spent on creation of electronic submissions.
In summary, the transition to electronic submissions for IND-phase submissions can be difficult, but represents a real economic and time-effective choice for innovative early-stage companies.
Cato Research is a full-service CRO with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. One of Cato’s specialties is outsourced regulatory publishing, and they bring considerable expertise and experience to creating and maintaining NDAs, BLAs and INDs in the eCTD format. For more information about Cato’s services, contact Christine Warrington at 919-368-5995. Also check back for a URL to Cato’s new blog, which will be launched shortly.
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Regulatory Software Technology Trends Survey
posted by Kathie Clark @ 6:56 PM
Monday, August 24, 2009
Recently, I caught up with my old friend Steve Gens (of Gens and Associates Inc.) to talk with him about a very interesting global survey he just completed on “Benchmarks of Emerging Technologies and Approaches for Collaboration and Document Management” in the Pharma industry. The 2009 survey was completed in partnership with Steve Scribner of International Life Sciences Solutions, as a follow-up to their well-received 2007 survey. Steve and Steve worked with 37 Pharma companies (including 17 of the top 20, but no very small companies) to understand their collaboration and document management practices, program priorities and challenges, technology landscapes, outsourcing, and total cost of ownership. Some of their findings may surprise you.
Here are a few key points from the Gens & Scribner survey (including both the expected and the surprising):
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Over 90% of respondents feel that their Electronic Document Management (EDM) solution for submission documents is effective, with less than 10% considering their solution ineffective; however 44% will be changing their systems within the next three years. All of the respondents had implemented an EDM solution.
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Top priorities for companies in the EDM area are integration with collaboration systems, enhancing system performance, improving searching, and reducing TCO
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Speaking of collaboration, just over 50% feel that they have an effective solution. The survey also provided insight on specific aspects of collaboration, such as collaboration with partners and regulators, with details available in the figure below.
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Adoption of XML authoring remains rare outside of the obvious areas of labeling, with less than 10% of companies reporting other applications such as clinical and nonclinical reports and protocols. Even in the labeling area, only 25% of companies are doing XML authoring themselves. Many companies are projecting to conduct pilots in 2010 & 2011.
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eCTD adoption was nearly universal, with only a couple of the participants (both Japanese) still researching or unsure about adoption.
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PIM, on the other hand, has been adopted by only about 15% of companies, with another 10% in the process. (and lots researching, probably due to the news that PIM will be mandated in the relatively near future).
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Out of the 37 companies, only 8 are submitting PIM right now – four top 20 and (surprisingly to me) four mid-tier
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Dossier publishing was outsourced to low cost regions at least in part by 15 out of the 37 companies, with India (4) and China (4), with 10 companies planning to expand outsourcing. Although companies are increasingly driven to overseas outsourcing due to economic reasons, they are also very concerned with Intellectual Property issues in many outsourcing regions.
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Twenty-four percent of EU participants outsource NeeS production. Out of that group, 31% were satisfied with their outsourcing arrangements and about 31% actively dissatisfied. Interestingly, satisfaction rates with eCTD outsourcing were significantly higher.
One conclusion that was surprising to Steve was that a great many companies do not yet collect metrics on cycle times and the efficiency and value of their EDM-related programs. Companies are also much slower to implement regulatory tracking than projected, most likely due to issues regarding data cleansing and harmonization/adoption of a global system by stakeholders used to many specialized if less capable local systems.
What’s Next?
Steve and Steve will be conducting individual debriefing sessions with the survey participants in the coming weeks. These sessions help the participating companies understand where they stand with respect to their peers in the industry. In previous years, the extremely detailed information provided to the participants has proven invaluable in confirming their direction and priorities or helping them re-plan. Having seen the detailed information and analysis that will be presented in the debriefing sessions (a subset was presented at the DIA Annual Meeting in June), I can well believe that the participants in the 2009 survey will conclude that the time they spent participating in the survey was a good investment.
If you didn’t participate in the survey, you may still be able to get more detailed information since Steve and Steve will most like make some of it available in a series of articles or presentations in upcoming months. Contact information is as follows: Steve Gens (sgens@comcast.net) and Steve Scribner (SteveScribner@nc.rr.com). They have over 40 years experience in the Life Science industry and both their companies provide consultancy services (Strategy, Implementation Planning, and Program Management).