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
BY THE NUMBERS
Results you can trust
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.
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.
From genomics pipelines to lab automation, we build the data infrastructure and analytics platforms that turn your scientific breakthroughs into scalable products.
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.
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
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
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
Recognized for our GitHub Enterprise and DevSecOps expertise.
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.
CASE STUDIES
Our work in life sciences
"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."
"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."
"Modus Create understood our challenges and was committed to provide a solution that met our goals."
"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."
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
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.
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.