Accelerate Drug Development and Patient Outcomes With AWS
Sphere delivers HIPAA-compliant, GxP-ready cloud and AI solutions for life sciences and healthcare organizations – genomics analysis, clinical trial data platforms, real-world evidence analytics, and AI-powered clinical decision support – built on AWS HealthLake, SageMaker, and GovCloud.
Organizations around the world trust us
Why This Matters Now
Life sciences and healthcare organizations sit on the most valuable data in the world – genomic sequences, patient outcomes, clinical trial results – but most of it is locked in siloed systems, expensive on-premises infrastructure, and legacy data models that prevent modern AI from accessing it. Meanwhile, cloud adoption in regulated industries requires specialized compliance expertise that most AWS partners don’t have.
1. Regulatory Complexity Paralyzes Cloud Adoption
HIPAA, 21 CFR Part 11, GDPR, and ICH E6 requirements create a compliance maze that keeps life sciences IT teams stuck on legacy infrastructure years after it should have been modernized.
2. Siloed Data Prevents AI-Driven Discovery
Genomics, clinical, claims, and real-world evidence data sitting in separate systems makes the cross-dataset AI analysis that drives the most valuable drug discovery insights impossible.
3. Clinical Trial Infrastructure Is Manual and Slow
Trial data management, EDC integration, and regulatory submission preparation is still predominantly manual – introducing errors, delays, and cost overruns into every trial.
What Sphere Delivers
Sphere’s Life Sciences practice combines deep AWS expertise with hands-on regulatory compliance experience – building HIPAA-compliant, GxP-validated cloud infrastructure that actually gets through your compliance review process. Our team includes former FDA consultants and life sciences IT leaders who speak both AWS and regulatory language fluently.
HIPAA & GxP Compliant Foundation
Pre-built AWS infrastructure templates meeting HIPAA Security Rule, 21 CFR Part 11 electronic records, GCP (ICH E6), and SOC 2 Type II requirements. Validated infrastructure with IQ/OQ/PQ documentation.
AWS HealthLake Integration
FHIR R4-compliant health data lake on AWS HealthLake – enabling unified patient data storage, NLP-powered medical record analysis, and cross-dataset AI analytics.
Clinical Trial Data Platform
EDC integration, clinical data management system (CDMS) on AWS, regulatory submission data packages, and real-time trial monitoring dashboards.
Genomics Analysis Pipeline
Scalable genomics analysis pipelines on AWS – from raw sequencing data through variant calling, annotation, and population-level analysis – using AWS Omics.
AI Clinical Decision Support
SageMaker-based ML models for clinical risk scoring, drug-drug interaction prediction, adverse event detection, and patient stratification – with full model validation documentation for regulatory submission.
CSV & Computer System Validation
Validation-ready AWS platforms with risk-based CSV methodology, requirements traceability, test scripts, deviation handling, and change control documentation.
Built On Industry-Leading Technology
Built on AWS services designed for regulated healthcare and life sciences environments, Sphere creates secure platforms for clinical data, genomics workflows, medical NLP, and AI-driven analysis. This technology stack supports compliant data storage, governance, interoperability, and machine learning across FHIR, DICOM, and other healthcare systems – giving life sciences teams a practical foundation for research, operations, and patient-focused innovation.
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Who This Is For
Drug discovery AI, clinical biomarker analysis, and real-world evidence analytics on unified AWS data platform.
Scalable clinical trial data management infrastructure supporting Phase I–IV trials across multiple therapeutic areas.
Population health analytics, clinical risk stratification, and care gap identification using AWS HealthLake.
HIPAA-compliant cloud infrastructure for connected medical devices, patient apps, and remote monitoring platforms.
Claims analytics, prior authorization AI, and member health risk modeling on compliant AWS infrastructure.
Schedule a Life Sciences Cloud Assessment
Sphere’s life sciences IT experts will review your current infrastructure, compliance requirements, and priority use cases – and propose an AWS cloud modernization roadmap with full compliance architecture and projected ROI.
How It Works
Compliance Assessment
Review regulatory requirements, existing systems, and data governance policies. Define compliance architecture.
Foundation Build
Deploy HIPAA-compliant AWS Landing Zone with validated security controls, logging, and access management.
Migration & AI
Migrate clinical, genomic, or operational data to AWS with full chain of custody documentation. Build analytics pipelines, ML models, and application layer on compliant foundation.
Validation & Audit
IQ/OQ/PQ validation, penetration testing, and audit trail review for regulatory submission readiness.
Compliance Assessment
Review regulatory requirements, existing systems, and data governance policies. Define compliance architecture.
Foundation Build
Deploy HIPAA-compliant AWS Landing Zone with validated security controls, logging, and access management.
Migration & AI
Migrate clinical, genomic, or operational data to AWS with full chain of custody documentation. Build analytics pipelines, ML models, and application layer on compliant foundation.
Validation & Audit
IQ/OQ/PQ validation, penetration testing, and audit trail review for regulatory submission readiness.
ROI & Business Impact
Faster trials, lower compliance overhead, measurable savings
Life sciences companies using Sphere’s AWS platform report 50% faster clinical trial timelines, $2M–$8M annual cost savings from infrastructure modernization, and 60–80% reduction in regulatory compliance overhead.
Time-to-market value for pharmaceutical programs
For pharmaceutical companies, accelerating a single trial by 6 months represents $10M–$50M in value from faster time to market.
Hear from
our clientsHear from our clients
Lee Ebreo
VP of Engineering at Credit Ninja
These things would not have been achievable if we did not build our own in-house system and if we did not partner with Sphere to help us achieve our goals.
Selah Ben-Haim
VP of Engineering at Prominence Advisors
Our experience with Sphere and their team has been and continues to be fantastic. We keep throwing new projects at them, and they keep knocking them out of the park (including the rescue of a project that was previously bungled by another vendor).
Ben Crawford
Senior Product Manager at Enova Financial
I would expect to be delighted. It's been a really positive experience, working with Sphere, and I would expect you to have the same.
Mark Friedgan
CEO at CreditNinja
Sphere consistently prioritizes the needs of their clients, demonstrating both agility and teamwork. As an offshore team, they have been an integral part of our organization and we plan to continue growing with them.
René Pfitzner
Co-Founder at Experify
Sphere provided excellent full-stack development manpower to augment our team and help push our product forward. They are easy to work with, tech-savvy and proactive.
Bruce Burdick
Chief Information Officer at Integra Credit
We've been working with Sphere and its excellent consultants since our founding. I've found that they are true partners in the success of our business.
Jemal Swoboda
CEO at Dabble
The resources and developers that Sphere Software provides are skilled and have the required technical expertise, but more importantly, they have helped us build a culture of excellence within our team.
Arthur Tretyak
Founder and CEO at IntegraCredit
With Sphere, we were able to migrate in half the time it would take to train an additional FTE… and for a fraction of the cost. Our experience with Sphere has been exceptional.
Lee Ebreo
VP of Engineering at Credit Ninja
These things would not have been achievable if we did not build our own in-house system and if we did not partner with Sphere to help us achieve our goals.
Selah Ben-Haim
VP of Engineering at Prominence Advisors
Our experience with Sphere and their team has been and continues to be fantastic. We keep throwing new projects at them, and they keep knocking them out of the park (including the rescue of a project that was previously bungled by another vendor).
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