Effectively and compliantly managing clinical development programs that evaluate the efficacy, safety, and tolerability of new therapies requires close internal collaboration, including regulatory operations, which like many functional areas, can no longer operate in a silo. Driving this collaboration is the slowly evolving shift from paper to cloud-based regulatory information management systems (RIMS) to address regulatory operations challenges, such as information sharing, changing regulatory requirements, managing a global network and multiple products, track commitments, and streamline submissions and approvals.

The traditional regulatory technology landscape has not made life easy for regulatory operations to have visibility into the progress of submission development. It is not uncommon for publishers to receive final submission documents at the last minute-or close to the submission due date, leaving little time to publish, validate, and submit the submission to the respective health authority.

“Disparate systems, trackers, and divergent processes make it difficult for regulatory to allocate resources for known major filings, in addition to routine or maintenance filings, and the planning becomes more complex when you factor in the unknowns (e.g. HA information requests),” says Rachel Belani, director, Vault RIM, Veeva Systems. It’s just in the last three to five years that this is changing, because modern cloud technology allows regulatory to plan more effectively, identify potential risks earlier in the process, and have real-time visibility into the completion status of critical path deliverables.”

Current disjointed systems

A common scenario in many regulatory operations groups is a disjointed mix of homegrown and legacy systems, email, spreadsheets, and file-hosting services for tracking and sharing regulatory data.

“There is often a patchwork of systems and processes in place to get the job done, and as a result, regulatory professionals are working with a combination of stand-alone document management systems, spreadsheets for planning and tracking submissions, files shares, and stand-alone archiving systems-making it difficult for regulatory staff to understand what has been submitted, and ultimately accepted by health authorities,” says Belani.

For a big pharma like Merck Healthcare KGaA, Darmstadt, Germany, its core regulatory information management system was no longer being supported, and updated releases were not meeting needs and expectations, explains Regina Freunscht, vice president, global head of regulatory operations, Merck Healthcare KGaA. Managing large and complex electronic submissions with numerous systems (document management, RIM, publishing tool, and publishing archive, complemented by numerous planning trackers and project management tools) had become an increasing battle, she says. The cloud-based Vault RIM provides Merck Healthcare KGaA a centralized hub for storing and sharing documents, data, and information that drive completion of critical regulatory activities.

After almost 25 years in the industry, Sonja Justice, director for global regulatory operations, Amicus Therapeutics, says she is witnessing the industry begin the transformation from paper to cloud. As a small biotechnology company, Amicus relied on email correspondence and a network file-sharing share system. But the company is growing from having one product in its pipeline to multiple products and is working in multiple countries. Additionally, Amicus, which is focused on addressing unmet needs for rare and orphan diseases, has more than doubled its employees in the last few years.

These various factors were the tipping point for finding a way to centralize its product information. Amicus also chose to implement the cloud-based suite of RIM applications from Veeva. Amicus implemented the submission document management and regulatory submissions archive components last year, and is currently implementing the product registration tracking application.

Amicus has one commercial product on the market and is submitting dossiers for several investigational products. “Having a defined manner of finding documents or submissions related to these products and the ability to look at historical data in the Veeva system is much more efficient than trying to search information in a network file-share system,” says Justice.

Managing information and a broad product portfolio across a global network can be inefficient if a patchwork of systems is used. “With the complexity of our product portfolio that we manage around the world, we needed a system that eased our work, is globally available, and meets the changing and improving demands from various health agencies,” says Freunscht. “Although our regulatory system landscape was connected, we did not have a harmonized data strategy across our systems. This complicated analytics on our regulatory data and made joint/co-development of our assets with other companies and academic centers difficult. As a result, reuse of dossiers and managing parallel submissions across the globe was a complex and difficult task.”

To address the myriad of regulatory requirements, IQVIA developed the modular, cloud-based RIM Smart, says Ronan Brown, senior vice president, integrated technology and compliance solutions, IQVIA. Utilizing proprietary artificial intelligence (AI) and machine learning (ML) algorithms, RIM Smart includes an embedded, real-time regulatory intelligence database that covers most of the world’s regulatory requirements. “We scan this information continually and update the database so that users are compliant with requirements,” he says.

The ever-changing regulatory scenario in the market proves to be one of the important driving factors for adoption of regulatory information management software. Since 2000, FDA has issued thousands of regulation changes with regard to reporting requirements, and pharma struggles to keep pace. According to Coherent Market Insights, the global RIMS market was valued at $797.2 million in 2018 and is projected to exhibit a CAGR of 13.7% over the forecast period (2019–2027), owing to the increasing volume of data to be collected and provided by regulatory bodies.

Cindy H. Dubin, Contributor, Applied Clinical Trials