{"id":45324,"date":"2022-01-17T09:00:14","date_gmt":"2022-01-17T09:00:14","guid":{"rendered":"https:\/\/www.arisglobal.com\/?p=45324"},"modified":"2022-01-17T09:00:14","modified_gmt":"2022-01-17T09:00:14","slug":"connected-data-interoperability-regulatory-compliance","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/connected-data-interoperability-regulatory-compliance\/","title":{"rendered":"Connected Data, Interoperability Enable Greater Compliance and Beyond"},"content":{"rendered":"

Regulatory teams\u00a0serve as the\u00a0common thread of\u00a0pharmaceutical research and development, connecting each domain on a drug\u2019s journey to approval. Theirs is the only function that plays a role in every stage of bringing a drug to market, from initial\u00a0research through trial, to regulatory approval, and even\u00a0in\u00a0post-marketing\u00a0pharmacovigilance.\u00a0It would be reasonable to assume, then, that these teams should have access to\u00a0all\u00a0data and evidence being generated and utilized throughout the R&D process;\u00a0but in fact, most do not.\u00a0<\/span>\u00a0<\/span><\/p>\n

\"A<\/p>\n

That\u2019s because most biopharmaceutical\u00a0companies\u00a0are still relying on legacy technology that siloes the pivotal\u00a0arms of the organization. This is especially challenging for\u00a0Regulatory\u00a0teams, because these teams are tasked with\u00a0both\u00a0keeping their\u00a0colleagues\u2019 workflows compliant and\u00a0carefully\u00a0compiling\u00a0data\u00a0from across a drug candidate\u2019s lifetime\u00a0for approval by various regulatory bodies, like the FDA or\u00a0EMA.\u00a0<\/span>\u00a0<\/span><\/p>\n

So far, Regulatory\u00a0teams have made do.\u00a0But as\u00a0R&D increases in complexity\u00a0and caseloads\u00a0rise,\u00a0Regulatory\u00a0teams\u00a0need\u00a0a modern, single-source-of-truth\u00a0solution that will provide access to all the information and data being collected at every stage of\u00a0development\u00a0\u2013\u00a0as well as a clear view\u00a0into\u00a0Clinical operations and Safety monitoring\u00a0\u2013\u00a0in order to maintain compliance.\u00a0<\/span>\u00a0<\/span><\/p>\n

Evolving needs and pressure<\/span><\/b>\u00a0<\/span><\/p>\n

The COVID-19 pandemic\u00a0fundamentally changed public perception<\/span><\/a>\u00a0of how quickly treatments should come to market.\u00a0Between that tonal shift and growing competition between\u00a0biopharmas\u00a0\u2013 both established and emerging\u00a0\u2013\u00a0Regulatory teams are under increasing pressure to\u00a0shorten the time between lab and medicine cabinet.\u00a0<\/span>\u00a0<\/span><\/p>\n

Regulatory\u00a0teams\u00a0can do this by identifying risks early to avoid mistakes\u00a0or failed trials;\u00a0ensuring compliance\u00a0so\u00a0their\u00a0organizations\u00a0aren\u2019t hit by costly delays; and\u00a0by submitting clean submissions to regulatory bodies to minimize findings. If the entire process is thorough, compliant, and well-documented,\u00a0the drug has a higher chance not just of getting approved, but of getting approved faster.\u00a0A CenterWatch study found that delayed trials impact\u00a0both study costs and subsequent sales,\u00a0<\/span>causing potential losses of $600,000 to $8 million per day.<\/span><\/a>\u00a0<\/span>\u00a0<\/span><\/p>\n

By sharing data seamlessly across the organization through a\u00a0<\/span>cloud-based RIMS\u00a0solution<\/span><\/a>,\u00a0biopharmas\u00a0can give their Regulatory teams nearly real-time access to\u00a0data libraries and Clinical operations, empowering these employees to work\u00a0smarter and more efficiently.\u00a0<\/span>\u00a0<\/span><\/p>\n

One data source\u00a0expedites\u00a0submissions<\/span><\/b>\u00a0<\/span><\/p>\n

If Regulatory\u00a0teams\u00a0are\u00a0to fulfill\u00a0their\u00a0necessary role in each phase of R&D,\u00a0they\u00a0will need visibility into the goings-on\u00a0within each domain. Establishing a single source of truth for the entire organization\u00a0benefits\u00a0Regulatory teams in several ways.\u00a0<\/span>\u00a0<\/span><\/p>\n

A single source of truth \u2013 and access to\u00a0all\u00a0the organization\u2019s data \u2013\u00a0makes it faster and easier for Regulatory teams to compile\u00a0and submit the documentation\u00a0required by\u00a0various\u00a0regulatory bodies.\u00a0Rather than relying on pre-existing narrative documents or dossiers, which could contain outdated information or\u00a0be missing key figures, a central data repository allows Regulatory teams to pull what they need directly from the source. By giving Regulatory\u00a0teams\u00a0access to the\u00a0source of the data, they can save time\u00a0searching for the right\u00a0documentation or translating pre-written reports into the format required by the governing agency.\u00a0For example:\u00a0raw data is easier to format into region-specific requirements like\u00a0<\/span>IDMP.<\/span><\/a>\u00a0<\/span><\/p>\n

Providing such direct access to Regulatory teams also\u00a0enables\u00a0them 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.\u00a0\u00a0Consistent submissions are less likely to draw scrutiny or red flags,\u00a0thereby shortening the\u00a0overall approval process.\u00a0<\/span>\u00a0<\/span><\/p>\n

This process can even work in reverse:\u00a0by empowering Regulatory teams with better insight into the goings-on of other departments,\u00a0these employees can identify hurdles and gaps in data collection during the\u00a0trial phase, so they can be addressed and corrected before it\u2019s time to submit the findings.\u00a0This means fewer gaps, less missing information, and stronger evidence and submissions.\u00a0<\/span>\u00a0<\/span><\/p>\n

\"A<\/p>\n

Real-time oversight and course correction<\/span><\/b>\u00a0<\/span><\/p>\n

In addition to collecting data for the Regulatory team\u2019s own submission needs, an end-to-end data sharing policy\u00a0and cloud-based technology solution benefits\u00a0the Clinical team by ensuring\u00a0Clinical and Regulatory are in tune along every step of the R&D process.\u00a0<\/span>\u00a0<\/span><\/p>\n

With real-time communication\u00a0that eliminates the need for constant document\u00a0upload and download,\u00a0Regulatory teams can ensure they always have the most up-to-date forms and\u00a0regulations and can keep an eye on Clinical operations.\u00a0Access to more data also enables greater Regulatory intelligence capabilities through AI,\u00a0so Regulatory teams can identify\u00a0delays\u00a0and\u00a0conduct RCAs faster.\u00a0This is a huge benefit to the Clinical team, which\u00a0needs its Regulatory counterpart to maintain compliance or run the risk of\u00a0delays or even rejection from a governing body.\u00a0<\/span>\u00a0<\/span><\/p>\n

Of course, these benefits extend beyond Clinical, too.\u00a0Having the underlying data instead of approved dossier documents as the golden source of approved product information\u202fenables other avenues of automation for cross-functional processes. Consider the benefits of a central Regulatory database for automating the MedDRA\u00a0coding\u00a0of clinical particulars for Safety case reporting, or the ease with which\u00a0a Medical Affairs team could access approved product information from the same source of truth that is\u00a0enabling Regulatory oversight.\u00a0<\/span>\u00a0<\/span><\/p>\n

Benefits for the whole organization<\/span><\/b>\u00a0<\/span><\/p>\n

Because Regulatory\u00a0teams\u00a0play a role in every phase of development, it\u2019s every domain that benefits when Regulatory teams gain greater insight.\u00a0From keeping Clinical teams compliant to providing the necessary framework for Safety reports,\u00a0providing Regulatory teams with the appropriate technology benefits the\u00a0entire organization.\u00a0<\/span>\u00a0<\/span><\/p>\n

Ready to learn what a unified RIMS solution could mean for your organization? Learn more at\u00a0<\/span>https:\/\/www.arisglobal.com\/lifesphere\/regulatory\/<\/span><\/a>.<\/span>\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Regulatory teams\u00a0serve as the\u00a0common thread of\u00a0pharmaceutical research and development, connecting […]<\/p>\n","protected":false},"author":27,"featured_media":48208,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[],"class_list":["post-45324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"\nConnected Data, Interoperability Enable Greater Compliance and Beyond | ArisGlobal<\/title>\n<meta name=\"description\" content=\"Because Regulatory teams play a role in every phase of development, it\u2019s every domain that benefits when these teams gain greater insight through shared data.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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