As regulatory information management (RIM) becomes more complex, many pharmaceutical companies are looking towards specialised software solutions to help them with the process of submission. Wim Cypers, vice-president, regulatory affairs at ArisGlobal, explains how an integrative approach to data can help create a strategic advantage.
Across the pharmaceutical industry, the regulatory picture is becoming steadily more complex. While the sector has always been rule-bound, the last five to ten years have seen an influx of new standards that are changing the way pharma companies are run.
From EMA's extended medicinal product dictionary (xEVMPD) to ISO standards on the identification of medicinal products (IDMP), pharma companies must submit more detailed information than ever before. Just a dossier will no longer suffice.
The task becomes more challenging still when one considers the lack of international harmonisation. Meeting US regulations is one thing, but that will not help you gain drug approval in Asia; it's crucial to ensure compliance across every single one of your markets.
"If you don't manufacture products according to the approved criteria, you might end up with recalls or having to take batches off the market," warns Wim Cypers, vice-president, regulatory affairs at ArisGlobal. "In the worst-case scenario, you might lose your whole licence to sell the product."
Unfortunately, as data becomes more voluminous, storage becomes more difficult and regulatory information management (RIM) a herculean task. While in times gone by, it could be accomplished with a simple Microsoft Excel spreadsheet, this is no longer the case. Pharma companies require specialised solutions that will save them the burden of having to develop a system internally and free up time to focus on their product.
ArisGlobal specialises in precisely such solutions. A market-leading software vendor for the life sciences industry, it provides a comprehensive product range across four domains: pharmacovigilance and safety, clinical research, medical information management and regulatory affairs. These can be deployed individually or together, on a flexible hosted platform suitable for organisations of any size.
"Meeting US regulations is one thing, but that will not help you gain approval in Asia; it's crucial to ensure compliance across all markets."
Our software helps companies address their complex needs, ensuring they can submit their data in a compliant fashion, so they can focus on developing safer and better products," explains Cypers.
ArisGlobal has been around since 1987 and its offering continues to evolve in accordance with clients' needs. In recent years, it has helped many companies make the transition away from paper and towards electronic data submission. Its tools provide a complete end-to-end automated process, allowing for speedy submission of product data and internal expedition of processes.
"One major challenge for pharmaceutical companies is sharing information between departments," says Cypers. "There is always a delay when you do things with paper. Making electronic information from different departments easily available enables your organisation to be more agile - and gets products to market more quickly."
This is not just about compliance, but also about creating a strategic business advantage. With a successful RIM strategy, pharma companies can achieve faster return on investment and quicker statistical analysis in the event of a safety concern.
More than 200 life sciences companies and CROs worldwide currently rely on ArisGlobal's solutions, including 32 of the world's top 50 pharmaceutical companies. With offices in the UK, France, Germany, Ireland, India and Japan, the US-headquartered organisation provides a complete information management environment for life sciences organisations.
It is this broad focus that, Cypers believes, makes the company unique. "Although we have all these individual domains, it's important that the industry gets a consolidated view of that data," he says. "A lot of other companies are very focused on a specific area and don't have a complete view of what a pharma company needs."
Indeed, with a full range of services, including planning, design, upgrade, migration, optimisation, application verification and training, ArisGlobal provides a one-stop shop for all aspects of software implementation. Because many of its experts have a life sciences background, they are capable of dealing with the most exacting client requirements.
"I'm a trained pharmacist myself, so I can relate to the customer," says Cypers. "We have business experts working together with IT experts on the development of particular solutions. We want to be the best in class in all our individual domains, while integrating them at a company level. These are the key elements that make us stand out from the competition."