I’m excited to announce that BrightInsight has been named a top compliance solutions provider by CIO Review
magazine, reflecting our commitment to innovation and quality, exceptional customer service, corporate growth, and technology performance. This latest recognition reinforces our leadership in regulated digital health, and is a tribute to our incredible team.
The slow but steady transition from legacy systems to innovative tech-driven applications has come with a surge in regulatory mandates. Because most digital health solutions are developed for global markets, differences in mandates across geographies make it challenging for biopharma and medtech companies to launch digital solutions quickly – and in compliance with local regulatory jurisdictions.
Our SaaS-based platform leverages innovative software and services to capture, transmit, and analyze data from CE-marked and FDA-regulated apps, algorithms, medical devices, combination products, companion diagnostics, and Software as a Medical Device (SaMD), to help clients scale their regulated digital health products across regions. Built with a microservices-based architecture, enabling rapid iterations of functionalities while maintaining compliance with a continuously changing regulatory landscape, BrightInsight eliminates the complexity of updating a digital health solution’s feature set. We continually monitor developments in the evolving healthcare compliance arena, helping clients stay in lockstep with them to accelerate time-to-market and ultimately drive better patient outcomes.
Building compliant digital health products from scratch is complicated and time-consuming, posing a challenge in a sector where speed is paramount. BrightInsight helps clients cut their solution development efforts by 70 percent, accelerating go-to-market with configurable Accelerator Modules on the BrightInsight®️ Platform. Biopharma Commercial teams use the Accelerator Modules to speed the launch of digital health solutions for everything from patient diagnosis and selection, to dose calculation and disease management. Clinical development teams use the software’s robust capabilities to quickly stand up clinical trials of digital health products.
For example, global pharma company AstraZeneca leveraged our platform to monitor and maintain the compliance requirements of both the consumer-facing and clinical portals of its AMAZE Disease Management Platform. BrightInsight took AstraZeneca’s AMAZE Disease Management Platform from project kick-off to commercialization in less than a year.
In a similar case, leading pharma company Roche / Genentech approached us during the development of a dosing calculator for treating Haemophilia A, a rare disorder that affects some 400,000 people worldwide. BrightInsight helped Roche / Genentech build its regulated SaMD dosing calculator in less than 6 months.
In both cases BrightInsight ensured that the building blocks of clients’ digital health solutions were compliant, future-proofing their delivery and impact on patient health.
Boosting go-to-market times for digital health solutions, across a plethora of therapy areas and use cases (including patient diagnosis and selection to dose calculation, adherence, and disease management), is the heart of our success. BrightInsight’s proven track record, robust ISO 13485-certified Quality Management System, and comprehensive list of certifications (including MDSAP, HDS, ISO 62304:2015, ISO 27001:2013, HIPAA, and GDPR), has also helped to establish its leadership position in the digital health market. We regularly undergo customer and third-party audits to support re-certifications and verification of procedures, ensuring our readiness to support clients’ regulated digital health products in a compliant manner.
We’ve always been dedicated to bringing the benefits of digital to healthcare, aiming to improve outcomes for patients everywhere. This most recent recognition from CIO Review reinforces our leadership in biopharma and medtech regulated digital health, and I’m looking forward to keeping you up to date as we help our clients where it matters most: improving patient outcomes the world over.