Avalis Publishing, a business partnership built around Lisa Johnson and Alison Moraska, provides electronic Common Technical Document (eCTD) submission and other electronic regulatory publishing expertise to small and mid-sized companies. The focus of its activities is on submissions to the US Food and Drug Administration (FDA). The company deals with documents ranging from pre-Investigational New Drug Application (pre-IND stage through to post-marketing support, such as promotional materials, labeling, annual reporting and supplemental applications.
Compliance, document integrity and a watertight version control process underpin all its publishing activities. Version control is a key factor as the two business partners deal with a large number of document updates and changes. Many of its clients do not have direct expertise in publishing the required regulatory documents.
A brief encounter with the “sleeping rabbit”
The business relationship between Avalis Publishing and Schlafender Hase dates back some seven years to an industry event in which Schlafender Hase was participating as a vendor. While strolling through the vendor hall, the two business partners noticed the unusual “sleeping rabbit” logo and, intrigued, approached to investigate. Discussion ensued and the company decided to trial TVT, the Text Verification Tool from Schlafender Hase. This marked an initial step away from manual proofreading. Alison Moraska explains: “Especially with our larger documents and labeling, we needed to do time-consuming checks line-by-line, paragraph-for-paragraph, often with someone else doing an additional check. Manual proofreading was not perfect, as we’re all human, and it costs a lot of time.”
The partners at Avalis Publishing immediately recognized the advantages of verifying versions using TVT, and purchased a license. “Many software vendors are geared primarily to larger companies, whereas we recognized that the solution from Schlafender Hase was also applicable to us as a small company. It’s important to be able to trust the software we use,” Alison Moraska adds, “and we know we can trust TVT.”
Ms Moraska points out that the company deals with many amendments and last-minute changes. Furthermore, there are cases when a client will deliver documents in two versions – one in track change and the other in integrated clean copy. By running the documents through TVT, she can immediately see any discrepancies between versions and inform the customer. Additionally, when transferring content from customers into clean templates, TVT is especially important for providing certainty that content transfer is complete and identical to the original source file. This extra level of thoroughness in version control leads to greater document integrity, higher quality of service and client trust.
TVT promotes efficiency and compliance
The portfolios of clients who turn to Avalis Publishing are growing, and the time saved through document comparison software translates into capacity to manage higher workloads and more time to focus on other tasks at hand. Gone is the doubt that, through manual processes, document version issues might arise. Another outcome has been that that TVT can be used effectively as a “diagnostic tool” in the publishing process. “After running a comparison, I immediately know the extent of changes in an update, how much work will be involved and the best path forward – whether I just need to replace a few pages or republish an entire document,” Alison Moraska explains.
The result: TVT represents a quantum leap in version management, promotes efficiency and has fostered even greater trust between Avalis Publishing and its clients. Furthermore, as a small company, Avalis Publishing values its excellent working relationship with Schlafender Hase over the past seven years, and the “next level customer service” Schlafender Hase provides.
About Avalis Publishing
Founded as a “partnership by design” in 2008 by Lisa Johnson and Alison Moraska, Avalis Publishing provides regulatory operations support for biotech and pharmaceutical companies based on the three principles of quality, compliance and purpose. Its area of focus is strategic electronic publishing and eCTD support, particularly for US FDA submissions. This includes eCTD submissions, Regulatory Publishing, clinical study report publishing, document formatting for the regulatory environment, and eCTD strategy. It is headquartered in Boulder, Colorado.
