Regulatory teams serve as the common thread of pharmaceutical research and development, connecting each domain on a drug’s journey to approval. Theirs is the only function that plays a role in every stage of bringing a drug to market, from initial research through trial, to regulatory approval, and even in post-marketing pharmacovigilance. It would be reasonable to assume, then, that these teams should have access to all data and evidence being generated and utilized throughout the R&D process; but in fact, most do not.
That’s because most biopharmaceutical companies are still relying on legacy technology that siloes the pivotal arms of the organization. This is especially challenging for Regulatory teams, because these teams are tasked with both keeping their colleagues’ workflows compliant and carefully compiling data from across a drug candidate’s lifetime for approval by various regulatory bodies, like the FDA or EMA.
So far, Regulatory teams have made do. But as R&D increases in complexity and caseloads rise, Regulatory teams need a modern, single-source-of-truth solution that will provide access to all the information and data being collected at every stage of development – as well as a clear view into Clinical operations and Safety monitoring – in order to maintain compliance.
Evolving needs and pressure
The COVID-19 pandemic fundamentally changed public perception of how quickly treatments should come to market. Between that tonal shift and growing competition between biopharmas – both established and emerging – Regulatory teams are under increasing pressure to shorten the time between lab and medicine cabinet.
Regulatory teams can do this by identifying risks early to avoid mistakes or failed trials; ensuring compliance so their organizations aren’t hit by costly delays; and by submitting clean submissions to regulatory bodies to minimize findings. If the entire process is thorough, compliant, and well-documented, the drug has a higher chance not just of getting approved, but of getting approved faster. A CenterWatch study found that delayed trials impact both study costs and subsequent sales, causing potential losses of $600,000 to $8 million per day.
By sharing data seamlessly across the organization through a cloud-based RIMS solution, biopharmas can give their Regulatory teams nearly real-time access to data libraries and Clinical operations, empowering these employees to work smarter and more efficiently.
One data source expedites submissions
If Regulatory teams are to fulfill their necessary role in each phase of R&D, they will need visibility into the goings-on within each domain. Establishing a single source of truth for the entire organization benefits Regulatory teams in several ways.
A single source of truth – and access to all the organization’s data – makes it faster and easier for Regulatory teams to compile and submit the documentation required by various regulatory bodies. Rather than relying on pre-existing narrative documents or dossiers, which could contain outdated information or be missing key figures, a central data repository allows Regulatory teams to pull what they need directly from the source. By giving Regulatory teams access to the source of the data, they can save time searching for the right documentation or translating pre-written reports into the format required by the governing agency. For example: raw data is easier to format into region-specific requirements like IDMP.
Providing such direct access to Regulatory teams also enables them to prepare stronger submissions that will be subject to fewer changes by ensuring the submissions are consistent throughout the R&D lifecycle, which is preferred by regulatory bodies. Consistent submissions are less likely to draw scrutiny or red flags, thereby shortening the overall approval process.
This process can even work in reverse: by empowering Regulatory teams with better insight into the goings-on of other departments, these employees can identify hurdles and gaps in data collection during the trial phase, so they can be addressed and corrected before it’s time to submit the findings. This means fewer gaps, less missing information, and stronger evidence and submissions.
Real-time oversight and course correction
In addition to collecting data for the Regulatory team’s own submission needs, an end-to-end data sharing policy and cloud-based technology solution benefits the Clinical team by ensuring Clinical and Regulatory are in tune along every step of the R&D process.
With real-time communication that eliminates the need for constant document upload and download, Regulatory teams can ensure they always have the most up-to-date forms and regulations and can keep an eye on Clinical operations. Access to more data also enables greater Regulatory intelligence capabilities through AI, so Regulatory teams can identify delays and conduct RCAs faster. This is a huge benefit to the Clinical team, which needs its Regulatory counterpart to maintain compliance or run the risk of delays or even rejection from a governing body.
Of course, these benefits extend beyond Clinical, too. Having the underlying data instead of approved dossier documents as the golden source of approved product information enables other avenues of automation for cross-functional processes. Consider the benefits of a central Regulatory database for automating the MedDRA coding of clinical particulars for Safety case reporting, or the ease with which a Medical Affairs team could access approved product information from the same source of truth that is enabling Regulatory oversight.
Benefits for the whole organization
Because Regulatory teams play a role in every phase of development, it’s every domain that benefits when Regulatory teams gain greater insight. From keeping Clinical teams compliant to providing the necessary framework for Safety reports, providing Regulatory teams with the appropriate technology benefits the entire organization.
Ready to learn what a unified RIMS solution could mean for your organization? Learn more at https://www.arisglobal.com/lifesphere/regulatory/.