International submissions management specialist, ISI, is spearheading a collaborative, services-led approach to regulatory information management, in response to customer feedback that software tools alone are failing to help pharma organizations successfully manage international drug licence application submissions.
Harnessing a proven, best-practice based methodology, the new regulatory management services recognize that life sciences organizations continue to struggle with this complex discipline, despite a plethora of software tools that have been designed to give some structure to the problem.
A series of focus groups conducted by ISI earlier this year with 12 of the industry’s leading biopharma companies revealed an unmet need in the marketplace as new standards have emerged and are being implemented at different rates across different markets where submissions are being made. Participants reported that the challenge of actually keeping track of what’s been licensed where and what comprises the submission that’s going into a dossier in a particular country is becoming compounded by current regulatory environment. The research also found a difference in the way that U.S. and European organizations view regulatory information management. In Europe, efforts are primarily driven by compliance and risk efforts, while U.S. companies put financial drivers first and foremost in their decision making criteria for solutions as they seek new opportunities and potential new markets.
Yet, the widespread use of home-grown reporting systems, along with proprietary databases, spreadsheets, and other manual processes, has made the transition to a global regulatory information management approach difficult for many companies. To overcome the challenges, organizations have been adopting robust third-party software solutions that meet the compliance criteria of multiple regulatory authorities. But even these are failing to hit the spot.
“While there are many regulatory information management and tracking products on the market, including ISI’s own ISIRegTracker product, no single solution to date meets needs of the modern pharma company, primarily because regulatory tracking requires a broader process solution,” explains ISI’s European MD, Adam Sherlock “Early adopters have found existing regulatory tracking products very complex to implement, and data migration from disparate repositories almost impossible. The result is a series of systems that fail to deliver real value.”
To this end, ISI is applying a best practice approach alongside its customizable solutions to address varying regulatory challenges as they affect individual businesses and their particular target markets.
“Based on ISI’s experience in the regulatory space, we believe a business-oriented first step is crucial to implementing a successful regulatory tracking capability,” added Sherlock. “Many companies take inventories of the numerous point solutions globally but typically don’t explicitly determine the true five-year total cost of ownership for even each single solution—let alone the total cost of ownership for a portfolio of solutions. When a ROI analysis is done correctly, this analysis along with consideration of the company’s highly fragmented registration data usually amounts to wake-up call for senior management.”
In addition to its Return on Investment (ROI) tool, ISI’s approach directs the initial planning effort to the core challenge areas of data quality, management and governance; business process; and policy change. Once those aspects have been solidified, the traditional technology solution activities can be executed more efficiently and with greater success.
“Applying software in isolation is not going to work,” Adam emphasises. “Regulatory tracking and management is a complex business, and there is no quick fix to get it right. Applying best practices, experience and proven methodology at the start, however, will ensure the optimum implementation for the given company, maximizing the results delivered and giving the business full confidence that the software works as it needs to.
In tandem with its regulatory tracking advisory services and methodology, ISI offers its flexible tool, ISIRegtracker, which can be adapted to individual companies’ monitoring processes, requirements and environments.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc (imagesolutions.com) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations.
Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.