Industries
Life Sciences

Life Sciences Digital Transformation

Move faster in life sciences without cutting compliance corners

From clinical trial platforms to MLR automation to cloud modernization, we build the systems that help pharma, biotech, CRO, and MedTech teams move faster without cutting compliance corners.

✔️ AWS Certified Competencies in Life Sciences, Generative AI & Security

Life Sciences Hero

BY THE NUMBERS

Results you can trust

Saved in marketing costs for each digital therapeutics app
MLR automation achieved with EVERSANA ORCHESTRATE™ MLR
Per month saved for a clinical research firm
years partnering with Global 2000 firms, including life sciences leaders

WHO WE WORK WITH

Supporting every corner of life sciences

Pharma, biotech, CRO, MedTech. We know each one comes with its own constraints, its own stakes, and its own definition of done.

Pharmaceutical & biopharma

Speed up drug development, automate compliance workflows, and modernize your commercial and medical affairs platforms. We understand GxP, MLR, and the pressure of every submission deadline.

Biotech

From genomics pipelines to lab automation, we build the data infrastructure and analytics platforms that turn your scientific breakthroughs into scalable products.

CRO (Contract Research Organizations)

Reduce trial costs, improve site performance, and give your sponsors real-time visibility. We help CROs build the technology edge that wins business and delivers results.

MedTech

Connect devices, streamline regulatory submissions, and build the software layer that makes your products smarter. We bring engineering depth where it matters most.

Featured solutions

Accelerate your Pharma 4.0 initiatives

We work backwards from your unique challenges, co-creating purpose-built solutions that enable secure, compliant innovation: accelerating drug discovery, optimizing clinical workflows, and delivering measurable outcomes that advance patient care.

Automate medical, legal, regulatory (MLR) reviews with an AI-powered platform that flags risky claims, matches them to approved evidence, and streamlines approvals with clear audit trails.

TECHNOLOGY USED

  • Amazon Bedrock
  • Amazon S3
  • AWS Lambda
  • Amazon RDS

BENEFITS

  • Reduce manual review workflows
  • Faster time-to-market
  • Higher review accuracy

Accelerate and de-risk clinical trial strategies. Our Trial Design Optimization Copilot forecasts enrollment, optimizes country strategy, and models the impact of design changes.

TECHNOLOGY USED

  • Amazon Bedrock
  • Amazon Athena
  • Amazon QuickSight
  • AWS Lambda

BENEFITS

  • Identify enrollment risks before launch
  • Optimize country and site strategy
  • Shorten time to first patient

Convert real-world healthcare data into compliant, cited, decision-ready insights. All within a compliance-first workflow that integrates with your existing systems.

TECHNOLOGY USED

  • AWS HealthOmics
  • Amazon OpenSearch
  • AWS Clean Rooms
  • Amazon SageMaker

BENEFITS

  • Turn evidence cycles from months to days
  • Secure evidence sharing with partners
  • Maintain compliance and audit readiness

Automate lab data flows from instruments to cloud analytics and get validated datasets with full lineage and compliance.

TECHNOLOGY USED

  • Amazon S3
  • AWS Glue
  • Amazon SageMaker
  • AWS Lambda

BENEFITS

  • Instant access to validated lab results
  • Eliminate manual data handling errors
  • Accelerate time from experiment to insight

Deliver fast, reproducible variant calling, annotation, and reporting with validated pipelines on AWS.

TECHNOLOGY USED

  • AWS HealthOmics
  • Amazon EC2
  • AWS Batch
  • Amazon S3

BENEFITS

  • Improve accuracy with validated workflows
  • Compliance with full data provenance
  • 2X-3X faster processing time

Curate gene reports, visualize complex data sets, and share insights in one secure place. Built on AWS, the platform accelerates discovery while meeting strict regulatory requirements.

TECHNOLOGY USED

  • AWS CloudFormation
  • Amazon EKS
  • Amazon CloudWatch
  • Microsoft Entra ID

BENEFITS

  • Faster access to critical data
  • Scalable cloud infrastructure
  • Enhanced collaboration with stakeholders
healthcare and life sciences report

Insights from 100+ HCLS Leaders

Turn AI ambition into measurable ROI, without compromising compliance.

This report is built for life sciences leaders:

  • Product & digital leaders in pharma, biotech, & medtech
  • Clinical, regulatory, & data decision-makers
  • Teams scaling AI in highly regulated environments
GxP AI Readiness Assessment Checklist

GXP AI READINESS ASSESSMENT

Understand what your organization needs to scale AI responsibly

Turning AI ambition into measurable impact requires the right capabilities, controls, and governance. Our AI readiness assessment checklist helps regulated-industry organizations evaluate their current maturity, identify potential gaps, and understand what needs to be strengthened before deploying or scaling AI.

Our technology partners

Our technology partners

Built on the platforms your teams already trust

AWS Advanced Tier Partner — Life Sciences competency

AWS recognizes our work in regulated environments. We've earned it by delivering compliant cloud projects for pharma, biotech, and clinical research teams.

Atlassian Platinum Solution Partner

The highest Atlassian tier, earned through volume of certified consultants and projects delivered.

GitHub Partner

OUR EXPERTISE

One team, every capability you need

One partner, the full stack. From strategy to shipping to ongoing operations.

Generative AI, predictive models, and data platforms deployed on Amazon Bedrock and SageMaker. Every system we build in a regulated environment comes with validation documentation, governance, and audit trails as part of the work, not as add-ons.

As an AWS Advanced Tier Partner, we design, migrate, and run cloud environments that meet FDA, EMA, and GxP requirements. We've done enough life sciences migrations to know where the compliance traps are.

Most teams use Jira and Confluence. Few have them properly validated for regulated environments. We configure and validate the Atlassian ecosystem for life sciences teams who need audit readiness, not just project management.

We build the interfaces your clinical, commercial, and R&D teams actually want to use. Compliant doesn't have to mean clunky, and we prove that on every project.

GxP, FDA 21 CFR Part 11, HIPAA, SOC 2. We architect for security from the start, not at the end when it's expensive to fix.

Centralized data platforms that connect your research, clinical, and manufacturing data on AWS. Governed, integrated, and built for regulated environments.

Modites working together

MODUS COMPASS™

Which constraint is actually slowing you down?

Compliance debt, fragmented clinical and commercial data, AI pilots waiting on validation: most life sciences roadmaps carry all three at once. Compass™ is our assessment for deciding what to fix first. You leave with:

  • A current state analysis
  • Benchmarks against comparable organizations
  • Two or three prioritized actions, drafted by people who have shipped validated systems

Async, one-to-one, or as a workshop with your team.

CASE STUDIES

Our work in life sciences

MLR review automation: How EVERSANA automated 90% of reviews with GenAI case study

Case study • Life sciences

MLR review automation: How EVERSANA automated 90% of reviews with GenAI

EVERSANA partnered with Modus Create and AWS to develop a game-changing solution that automates over 90% of routine tasks in the complex Medical, Legal, and Regulatory (MLR) review process through a single platform that’s easy to implement and complies with all regulatory requirements.

Building an ML-powered platform to bridge gaps in cancer care case study

Case study • Life sciences

Building an ML-powered platform to bridge gaps in cancer care

Modus Create collaborated with a global biopharma leader to build a real-time cancer care platform powered by connected devices and patient data

Life sciences firm automates clinical trial design with AI case study

Case study • Life sciences

Life sciences firm automates clinical trial design with AI

A global life sciences firm reduced clinical trial strategy design from weeks to minutes and saved $5M+ in trial costs. See how Modus Create built an AI-powered clinical trial automation platform on AWS.

Life sciences company overhauls patient services model for faster treatments case study

Case study • Life sciences

Life sciences company overhauls patient services model for faster treatments

Modus Create analyzed 10,268 patient cases and designed a patient-centric operating model, identifying opportunities to reduce time to first fill by up to 20%.

Life sciences company fights smoking addiction with a patient engagement app case study

Case study • Life sciences

Life sciences company fights smoking addiction with a patient engagement app

Modus Create helped a life sciences company modernize its smoking cessation app and expand into digital biomarkers, improving quit success rate by 34%.

Protecting patient data with a security assessment case study

Case study • Life sciences

Protecting patient data with a security assessment

Modus Create’s security assessment helped one of the world’s leading pharmaceutical companies protect their patient data and strengthen their overall security posture.

A global pharma company accelerates drug discovery case study

Case study • Life sciences

A global pharma company accelerates drug discovery

Modus Create partnered with a leader in neurological research to develop a platform built on AWS that simplifies data analysis and helps accelerate drug discovery.

Clinical research firm saves $30K per month with cloud modernization case study

Case study • Life sciences

Clinical research firm saves $30K per month with cloud modernization

Modus Create helped a leading clinical research tech firm modernize its AWS environment, cut data failures by 95%, and save up to $30K per month.

How AI accelerated clinical trial protocol reviews for a global healthtech firm case study

Case study • Life sciences

How AI accelerated clinical trial protocol reviews for a global healthtech firm

Modus Create built an AWS-powered AI application that reduced clinical trial protocol review timelines by 50%, doubled analyst productivity, and cut error rates from 12% to 0.8%, while maintaining full GxP compliance.

Global pharma leader reinvents operations case study

Case study • Life sciences

Global pharma leader reinvents operations

Modus Create helped a leading pharma company create custom internal applications for field sales, global engineering, and executive teams, breaking down silos and boosting collaboration.

"A lot of startups would benefit from the experience Modus Create brought to the table. It has set a very solid foundation on which we can grow now."

Thomas
Thomas Hufener
CEO at Kaiko

"From a business value point of view, the AVP ensures cost savings of about 30%, and the time to market has been reduced from weeks to hours."

Lorenz Schweiger
Head of Business Development and Strategy for AVP at Audi

"Modus Create understood our challenges and was committed to provide a solution that met our goals."

Sapna
Sapna Aggarwal
PMO, Business Process Specialist at Sephora

"Modus Create was an amazing partner for our GitHub migration to the GitHub cloud. We needed someone that could come in with expertise and show us the way, not just supplement our capacity."

Mark Quigley
Global Leader for Engineering Effectiveness at Wayfair

LET'S GET STARTED

Talk to Modus Create

Big challenges need bold partners. Let’s talk about where you want to go — and start building the path to get there.

OUR EXPERTS

Meet the team behind your build

Greg Sterndale

Greg Sterndale

VP, Product Engineering Services

Matthew Kelch

Matthew Kelch

Director, Engineering

Matthew is Director, Engineering at Modus Create with 15+ years of experience in full-stack product development. A remote work advocate, Matthew helps enterprises of all sizes modernize their software development practices, including organizations in regulated industries such as Healthcare and Life Sciences.

OUR INDUSTRY RESOURCES

Insights on AI and innovation in life sciences

Explore our latest thinking on scaling AI, modernizing platforms, and navigating regulatory complexity in life sciences.

Use left and right arrow keys to navigate resource cards, or swipe on touch devices.

7 AI use cases driving real returns in life sciences
Blog

Seven high-impact, lower-risk AI use cases in life sciences that improve operational efficiency while keeping humans in control of critical decisions.

Economics, not regulation, is stalling AI in life sciences
Blog

Life sciences leaders can get more value from AI by prioritizing use cases where the business impact justifies the cost of scaling.

HIPAA-compliant software development: How engineering teams build in compliance
Blog

A practitioner's guide to HIPAA-compliant software: which Security Rule requirements apply, how to architect for PHI, and where compliance actually fails.

Stop treating compliance like a final exam
Blog

Learn how healthcare and life sciences organizations can build compliance into everyday engineering workflows, reducing delays while staying audit-ready.

Practical AI in healthcare & life sciences: How defined use cases are delivering real returns
Blog

In new research from Modus Create, over 100 healthcare and life sciences product leaders share how rising pressure from the C-suite is reshaping AI-fueled projects.

AI in life sciences: how to scale from pilot to enterprise-wide adoption
Blog

Learn from our expert guide how Pharma, Biotech, MedTech, and CRO organizations can implement AI effectively.

Modus Create intelligent apps readiness assessment life sciences
Blog

How do you know your organization is ready to deploy intelligent apps and realize AI’s tangible returns? Here are five questions to ask.

Modus Create's William Reyor on AI security and compliance risks
Blog

Amid AI hype, healthcare & life sciences teams need clarity. Learn how to deliver results that create meaningful, measurable impact.

Modus Create achieves AWS Life Sciences Competency
Blog

The AWS Life Sciences Competency differentiates Modus Create as an AWS Partner with validated technical proficiency, regulatory alignment, and a strong record of customer success.

Discover how AI is transforming life sciences with applications in drug discovery, diagnostics & more. Learn trends & strategies to power innovation.
Blog

By investing in the right areas of AI, life sciences companies can streamline processes, improve data-driven decision-making, and ultimately create a competitive edge in today’s complex market.

This blog explores the biggest security risks AI brings to life sciences
Blog

For life sciences executives, AI security isn’t just an IT problem—it’s a business-critical issue that can impact the entire organization.

EVERSANA unveils AI-powered solution built in collaboration with Modus Create and AWS
Blog

The solution will use AI to revolutionize the Medical, Legal, and Regulatory (MLR) process, providing unmatched accuracy, efficiencies, and compliance for life sciences companies.

Frequently asked questions

How does Modus Create handle GxP compliance and regulatory requirements?

It's part of how we work, not something we add at the end. Every solution we build for regulated environments includes validation documentation, audit trails, and architecture decisions aligned with FDA 21 CFR Part 11, EMA guidelines, and GxP principles. Our engineers have delivered validated systems for global pharmaceutical and biotech clients.

What makes Modus Create different from a traditional life sciences consulting firm?

We sit at the intersection of technology and life sciences, which means we bring both engineering depth and domain understanding to every project. Rather than stopping at strategy, we build and deliver the systems your teams actually use, from AI and cloud infrastructure to product development and platform engineering, all within the compliance requirements of regulated environments.

How do I evaluate a technology partner for an AI agent project in life sciences?

The most important thing to look for is experience in regulated environments, not just general AI expertise. A good partner will understand GxP validation, know how FDA 21 CFR Part 11 affects system design, and have already shipped AI in contexts where governance and audit readiness were non-negotiable. That's the work we do. If you're scoping a project, we're happy to talk it through.

What is agentic AI and how is Modus Create using it in life sciences?

Agentic AI refers to autonomous systems that plan and execute multi-step workflows independently, going beyond simple question-and-answer interactions. At Modus Create, we design and deploy multi-agent systems for life sciences use cases including regulatory writing, pharmacovigilance triage, medical affairs content management, and clinical operations monitoring. Every system we build includes GxP-compliant governance, full audit trails, and human-in-the-loop controls where regulations require them.