Digital strategy. Seamless execution.
We advise on people, processes, and platforms, and get hands-on to design, build, and implement solutions together with our regulated industry clients.
LEAP Consulting specializes in fast-moving regulated industries, delivering tailored digital strategies, build/buy analysis, and integrated software solutions that are secure and compliant.
Delivering digital excellence is in our DNA – it’s how we help our clients transform Regulated Industries.
Healthcare Telecom & Mobile Finance SAAS & Cloud ISVs
Digital Health, Precision Medicine, and Genomics are our focus.
With the kind of learning that comes from decades of digital experience in healthcare, LEAP offers full-lifecycle digital platform planning and implementation in Clinical, BioPharma, Research, and Informatics. Always integrated. Always compliant.
WHY LEAP
Technology-driven advice and solutions that leverage our industry-specific expertise, knowledge of best practices, and a deep understanding of available options for buy and build, integration standards, and the regulatory landscape.
Members of the community
Participating in industry associations, LEAP helps to define and deliver best-in-class patient care and research outcomes.
We are proud members of:
- HL7 / FHIR including genomics
- DICOM / CDISC
- BAM / FASTQ / VCF
- ANSI ASC EDI X.12
- MT940 / BAI / BAI2
- Bank lock-box files tied to remittances
Standards, securely in the cloud
Our experience adapting regulated industry published standards in practical applications is extensive.
- HL7 / FHIR including genomics
- DICOM / CDISC
- BAM / FASTQ / VCF
- ANSI ASC EDI X.12
- MT940 / BAI / BAI2
- Bank lock-box files tied to remittances
LEAP is also engaged with the major public cloud vendors to develop their use-cases in healthcare and their HIPAA-compliant offerings
- AWS
- GCP
- BAM / FASTQ / VCF
- Azure
- Salesforce
Compliance is in our DNA
Every discussion includes considerations for the validation, certification, and quality management regulations to ensure we achieves objectives and compliance.
- HIPAA
- SOX
- PCIDSS
- CLIA and CAP
- ISO 27001 and ISO 9001
- FDA 21 CFR Part 11 CSV/li>
- GLP and GMP
Read about our special offers for existing CLIA, CAP, and NYSDOH-certified laboratories seeking to comply with the 2024 FDA Final Rule on LDT Enforcement.
LEARN MORE >
Eager to help, respectful of boundaries
LEAP’s engagement models are designed to mirror your organization and culture. LEAP can support IT, Informatics, and Data Sciences alone, or in collaboration with your commercial, operational, clinical, and compliance teams.
FOCUS AREAS
From strategic plans and roadmaps to build/buy decisions and integration.
LEAP advises and implements what your organization needs.
IT Org & Process
- Tech Organization Design
- SDLC & ITSM Process Design
- Tech Planning Cadences
- Cloud-First Tech-Design
- Compliance First Tech-Design
- End-Users/Devices/Tools
- Orders2Cash Modeling
- Stakeholder Alignment
- Buy vs. Build vs. Partner
Enterprise IT Platform
- Stakeholder Persona Mappin
- Systems-of-Record & Events
- Enterprise Platform Design
- Connectivity Solutions
- Secure Hybrid Cloud
- SAAS/PAAS/IAAS/On-Prem
- EMR& PACS in the Cloud
- Master Data Strategies
- “Bus” Architectures
- Event Modeling
- Data Lifecycles
Lab IT & Bioinformatics
- Orders & Demographics
- LIMS Implementation
- Bench Automation
- Device Integration
- Discrete Results & Interfacing
- Variant Content Management
- Report Content Automation
- Storage & Big-Data Lifecycle
- Pipelines HPCC/Cloud
Patient Experience
- Digital-Front-Door
- Pre-Testing & Post-Testing UX
- Ordering Enablement
- Patient Education
- Indicators for Testing
- Test Information
- Benefits Investigation
- Patient Friendly Reports
- Patient Billing
- Post-Acute & Homecare
- Telemedicine
- Remote Patient Monitoring
- Chronic Care Management
Clinical Research & Data Monetization
- Cohort Stratification Tools
- Data Visualization Tools
- Ontology & Term Mappings
- Data Discovery for Partners
- Compliant Data Harvesting
- Data Enrichment Strategies
- Patient Consent Management
- Population Health Initiatives
Collaborator & Provider Experience
- Provider Persona Mapping
- Pre-Order Billing Support
- Digital Ordering Experience
- Digital Order Tracking
- Provider Results Delivery
- Post-Result Clinical Support
- Cohort Recall Management
- Analytics & Research Tools
New Test Design
- Target Disease States
- Ordering Variations
- Specimen Types / Kits
- Reflexes/Add-Ons
- Volumes/Batching/TAT
- TC-Only vs. Global
- Report Production
- Post-Report Provider Support
- Patient Results Experience
- Revenue Cycle/Reimbursement
Revenue Cycle
- Pre-registration
- Insurance Eligibility
- RCM Process & Tools
- RCM Vendor Review & Migration
- Provider Training & Tools
- Patient Collections
- Reimbursement Analytics
- Denials & Appeals Lifecycle
Lab Operations & Compliance
- Logistics & Specimen Routing
- Lab Incident Handling
- Operational Reporting
- Consumable & Labor Metrics
- Resource & Shift Utilization
- LIMS <-> ERP Data Ecosystem
Let our team of digital laboratory leaders and medical device regulation experts help you understand your obligations, assess your gaps, build a roadmap, and get compliant across your information systems.
Together, we’ll develop a path to compliance aligned with the phase-out approach.
