Derycz Scientific’s Leadership Aggressively Focused On Helping Pharma Companies

On its website, Derycz Scientific, Inc. (OTCBB:DYSC) describes itself as “The Information Logistics Company.”  For pharmaceutical firms and other knowledge-based businesses that deal with large volumes of peer-reviewed published literature, the value proposition of Derycz soon becomes clear :  The company facilitates and optimizes processes for procuring and using of full-text research articles from the lab to the clinic; supports good copyright practices for circulating such material to a company’s researchers; and provides dedicated customer-service support to oversee these outsourced services.

Derycz’s suite of products for content delivery and management has been garnering industry recognition—in August, its STM Document Delivery Service was named a Trend-Setting Product of 2011 by KMWorld Magazine—and the company recently announced plans to roll out additional products in the social, mobile, and search (SMS) realm in 2012.  We took time to reach out to Peter Derycz, Founder and CEO of Derycz Scientific, for some clarification on the company’s services and future plans.

Why would a pharmaceutical company need to work with Derycz Scientific?         

Peter Derycz, Founder and CEO of Derycz Scientific:  During the testing phase for a company’s new drug, its researchers will be searching through the millions of journal articles and other content that exist in support of the scientific process.  After this phase, clinical trials are carried out and the publication planning process accelerates, culminating in scholarly articles that will be submitted to peer-reviewed scholarly journals.  Once published, they become a significant component of a company’s investigatory new drug application (IND) submitted to the FDA and other agencies outside of the United States.  If the product achieves regulatory approval, the articles take on a new role as the promotional and educational efforts get underway.  Each step in this process presents its own challenges, which a dedicated content specialist like Derycz Scientific can help with.

Can you outline specifically what some of those challenges are?

Peter Derycz, Founder and CEO of Derycz Scientific:  There is the cost of locating, verifying, procuring, formatting, updating, and translating/localizing drug-related published content in the clinical and regulatory arenas.  It is well known that a submission to the FDA can easily run to a considerable length, as it consists of reviews and copies of published studies of the drug in question.  Assembling, sending and managing this mass of materials is a significant undertaking for any pharma company.  It is crucial for a company’s bottom line that this task be completed in as economical a fashion as possible and in a manner that avoids unnecessary duplication of materials or preparation errors that could lead to submission delays or rejections that ultimately affect shareholder value. A separate challenge involves managing the published content that is used by marketing, sales and medical affairs teams to help support the product following regulatory approval.

Is it really a challenge to prepare an FDA submission?

Peter Derycz, Founder and CEO of Derycz Scientific: Since 2008, the FDA has mandated that all electronic submissions adhere to the electronic Common Technical Document (eCTD) format. The eCTD format is also increasingly being adopted in countries outside of the U.S. As with all electronic submissions, delays will arise when last-minute requests for eCTD-quality documents are made. The eCTD format requires enhanced and specific digital document formatting and the inclusion of key navigation aids, making last-minute requests even more challenging. This is due to the fact that when regulatory authorities encounter non-compliant files, they can stop the review until the pharmaceutical company supplies them with corrected versions—a situation that can cost the company huge sums in lost revenue and sink a stock overnight.

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Source: BioMedReports