The Industry Is at a Breaking Point
Life sciences, pharmaceuticals, and biotech organizations are racing against time to develop life-saving drugs, bring medical devices to market faster, and comply with evolving global regulations all while controlling operational costs and ensuring patient safety.
But the reality is harsh:
- Systems are aging and disconnected, slowing down research and compliance.
- Supply chains are fragile, causing delays and cost overruns.
- Regulatory pressures are rising, with non-compliance risks increasing.
- Operational inefficiencies threaten profitability McKinsey predicts life sciences could lose 24% of EBITDA over the next decade due to cracks in supply chains and processes.
As national health spending heads toward $6 trillion by 2027, the stakes have never been higher. Companies need to reinvent how they operate to innovate faster and stay competitive.
What’s Slowing Down Life Sciences?
Life sciences organizations face multiple, deeply entrenched challenges:
- Fragmented Data: Clinical trials, EHRs, claims data, and real-world evidence (RWE) sit in silos, making analysis slow and incomplete. McKinsey estimates adopting RWE at scale could unlock $300M annually for top pharma companies.
- Regulatory Complexity: Manual compliance and reporting increase risk. Only 25% of top biotech compliance leaders say their systems provide real-time insights.
- Disconnected Systems: Manual workflows cause operational delays and increase error rates (up to 27% in data handling).
- Limited Risk Sharing: Few value-based contracts exist, though such models have shown to cut costs by nearly 5% and improve clinical quality by 6% (IHA study).
- Slow Time-to-Market: Global regulatory navigation and legacy systems delay critical treatments and product launches.
These inefficiencies don’t just hurt profitability they delay patient access to innovative, life-saving therapies.
AI + Low Code Changing the Biotech Game
To overcome these barriers, AI-powered low-code platforms are revolutionizing life sciences operations.
- Low Code: Build and adapt applications with minimal coding using drag-and-drop interfaces and visual workflows. This accelerates development cycles and reduces reliance on IT.
- AI and Analytics: Automate complex tasks, extract insights from massive datasets, and predict trends to improve decision-making.
- Machine Learning & Automation: Speed up processes like trial recruitment, compliance checks, and risk monitoring.
PwC forecasts that AI-driven diagnostics will capture 40% of the market by 2026, underscoring the industry-wide move to smarter, data-driven workflows.
Avoiding Technology Traps
Digital transformation in life sciences comes with its own risks. Common pitfalls include:
- Non-scalable solutions that can’t grow with the business, leading to costly upgrades.
- Integration gaps with legacy systems that create inefficiencies and data silos.
- Complex, rigid systems that require heavy customization and slow adoption.
- Poor vendor support leading to downtime and operational disruption.
Success strategy: Choose scalable, integration-ready, user-friendly platforms backed by trusted vendors to ensure long-term adaptability and ROI.
NewgenONE AI-Enabled, Low-Code Platform for Life Sciences
NewgenONE empowers life sciences companies to overcome complexity and accelerate innovation by uniting process automation, content management, and communication into one agile platform.
Key capabilities include:
For Clinical Trials
- Automate trial workflows from patient recruitment to data collection and adverse event reporting.
- Maintain transparent compliance with FDA and global regulators.
- Gain real-time visibility across trial milestones and data quality.
For Regulatory Affairs
- Centralize regulatory submissions and automate change management.
- Reduce errors and accelerate time-to-market with auditable workflows.
- Seamlessly integrate with existing global compliance systems.
For Market Access & Real-World Evidence (RWE)
- Consolidate diverse data (EHR, claims, third-party datasets) into one source of truth.
- Generate actionable insights instantly to support payers and providers.
- Improve communication of product value to regulators and stakeholders.
For Pharmacovigilance & Safety
- Centralize safety data, automate adverse event tracking, and monitor risks proactively.
- Provide compliance-ready safety reports across geographies.
For HCP Compliance & Transparency
- Automate healthcare professional (HCP) engagement tracking.
- Simplify Sunshine Act and EFPIA reporting with centralized repositories and real-time analytics.
For Quality & Supply Chain
- Enhance visibility into manufacturing and distribution processes.
- Automate quality checks, ensure compliance, and reduce cost of failure.
Why Leading Life Sciences Companies Trust NewgenONE?
- Unified Platform: Integrates BPM, ECM, and CCM for seamless process orchestration.
- AI-First Approach: Built-in machine learning, predictive analytics, and automation.
- Low-Code Agility: Rapidly build and deploy applications without heavy IT effort.
- Future-Ready Integration: Connects easily with legacy systems, modern APIs, and external databases.
- Compliance by Design: Audit trails, security, and built-in regulatory frameworks.
Life sciences organizations using NewgenONE have reported:
- Faster R&D and clinical trial execution
- Improved compliance tracking and reporting
- Stronger data-driven decision-making
- Reduced operational cost and risk
Measurable Impact
- 40% faster clinical trials with automated recruitment and reporting
- 30% lower compliance cost by eliminating manual monitoring
- Fewer supply chain disruptions with real-time visibility and risk alerts
- Accelerated time-to-market for innovative therapies and devices
The Path Forward
Life sciences can no longer rely on patchwork systems and manual workflows. The shift to AI-enabled low code is not just a tech upgrade it’s a transformation that enables faster innovation, stronger compliance, and better patient outcomes.
By investing in platforms like NewgenONE, companies can unify data, accelerate processes, and future-proof operations in an increasingly complex global healthcare environment.
Start Your Life Sciences Transformation
If your R&D, clinical trials, or compliance processes still depend on manual systems or fragmented tools, now is the time to modernize.
