Decentralized, Hybrid and Site-based
Clinical Research Management System

Product Overview

Via our Preferred Partnerships – we can help meet your recruitment goals at less cost, with exacting results and in less time – Our Comprehensive Feasibility Assessment assures recruitment goals will be met long before investing further into study launch.

Feasibility Testing with access to a pharmacy database of over 30 million pharmacy consumers and access to over 230 million weekly shoppers in 50 States in the U.S. within over 4000 geo-specific locations

Our system enables Patient Identification & Engagement – fulfill enrollment requirements in weeks not years

Unprecedented Reach to the under-served populations for clinical study diversity & inclusion, for the ultimate in Health Equity

  • SaaS or “Self Service” tools easily create pre-screening inclusion and exclusion criteria
  • Data collection fully compatible with GCP ICH guidelines, the FDA’s 21 CFR part 11 compliance, GDPR and California’s new CCPA
  • SaaS or “Self Service” tools easily create pre-screening inclusion and exclusion criteria
  • Data collection fully compatible with GCP ICH guidelines, the FDA’s 21 CFR part 11 compliance, GDPR and California’s new CCPA
  • Automated subject screening process – recruitment & screening information exports automatically for attachment to IRB applications
  • Live Data Reporting & Digital Dashboards within our EDC, allows the Sponsor, CRO, or EA to adjust recruitment efforts in real-time

Candidates access your trials through a customized mobile app available across all popular devices and configurable in multiple languages

Designed by an experienced team to be accessible, easy to use, and highly secure

Facilitates communications with the study team and includes advanced personal information (PI) redaction

Extensively researched and tested electronic informed consent with digital source documentation and digital fingerprinting

Multiple forms of identity validation available including automatic scan of Government issue ID or passport in 150+ countries

Any documents you need, update and re-sign during the trial


Generate shipping information, manage tracking data, confirm through barcode scanning


Supports CPG, Medical Device and Drug trials and includes randomization and blinding


Works with our 3rd party vendors or any major shipper such as UPS, FedEx or DHL


Supports pharmacy-based shipping




Tasks and

Interactive Dashboards

Rules and Role Based dynamic live data portal from the Laina Insights Engine™

  • 1. Minimize drop outs
  • 2. Improve protocol compliance
  • 3. Optimize subject population
  • 4. Enables ad hoc review of “live” blinded data
  • 5. Real time TLF population allows preliminary analysis in days, not months
  • 6. Supports PRO requirement for FDA submissions
  • 7. Facilitates Adaptive Study Design
    • Can course correct mid study for dosage, “N”, population demographics and more
    • No more waiting for a study to complete that is on track to fail
  • 8. Supported by Machine Learning (ML) & an Insights Engine for true Artificial Intelligence (AI)
    • Important for post marketing surveillance, longitudinal data assessments and insights, as well as BYOD centric studies
    • Enables the FDA’s vision for compression of the study phases
  • 9. Builds the business case for Market Access via behavioral data capture
    • Payor cost implications
    • Utilization data
  • 10. Focus:
    • Tracks adherence, compliance & positive behavioral changes

Laina Enterprises Insights Engine for True AI

  • Real World and Real Time data collection for Real World Evidence
  • Supports new data paradigm Real World Performance
  • Machine Learning (driven by custom Rules-based Engines for “Dynamic data” creating actionable insights
  • The system becomes smarter over time, system intelligence pushes Targeted content/communications developed based on deeper insights
  • Elimination of expensive ‘dead time’ enables the continuous study as proposed by the former FDA Commissioner Gottlieb
  • Affords compression of the study phases for Accelerated implementation of Iterative studies
  • Track data from individual subjects to large populations
  • Globally scalable
  • Company owned architecture built on open standards. No limitations, loss of ownership or control by Apple.
  • Available on all major consumer platforms. Components available as needed.
  • Sponsor controls the data dialogues.

Excellent for post-market surveillance

Clinically Validated easy homeuse devices collect a variety of health data

BYOD Metrics

Reliable and instant
health data

Automatic Health Data

From Apple, Fitbit, and

  • Collect and save data without access to the Internet
  • Data is transmitted when an appropriate connection is made
  • Study personnel can engage participants wherever they might be to collect data
  • Utilize clinically validated and ad hoc questionnaires
  • Capture and respond to all lab & test data
  • Record AE’s
  • eConsent & eSignature
  • Manage medications, vaccinations and supplementation
  • Record & view Medical History including symptom tracking
  • Manage daily, weekly and monthly tasks
  • Capture photo data
  • Query management feature
  • Customizable for any use case
Laina's virtual trial management system is the Preferred Partner for Walmart's recently announced
Healthcare Research Institute.
Read more

Key Benefits and ROI Enablement

  • Facilitates decentralized studies – No physical site needed
  • Access to over 4000 sites in geo-specific locations
  • Study Democratization for Diversity, Inclusion and Health Equity
  • Feasibility testing via access to 30 million pharmacy consumers
  • Recruitment access to over 265 million patients/consumers
  • Real-time AE and SAE reporting
  • “Adaptive Study & Master Protocol Designs” – AI with ML
  • @ home access improves adherence
  • Reach more participants with Mobile Direct Data Capture
  • Faster iteration and ideation through ultra low-cost trials

The Solutions

Laina SaaSTM

  • Low-cost, self-service studies designed for all phases
  • Full data security, HIPAA Compliance, 21 CFR Part 11, and other Laina security systems
  • Launch a study in just a few days with real-time recruitment and data dashboards
  • Available in most countries with clinical-grade translation and localization


  • 2nd-Gen 100% virtual site-less research management systems
  • Advanced security goes beyond 21 CFR Part 11, HIPAA, GDPR, and CCPA with Laina’s Source Audit SystemTM
  • Enabled complex studies with complex logic and detailed participant needs
  • Advanced tools for CRO, CRA, and EA to manage clinical trials

DDC Laina HybridTM

  • Combines the best of Virtual Trials and Site-based studies
  • Site tools combine ePRO, EDC and eCOA
  • Integration with 3rd party labs, appointment systems, home health providers and other healthcare services
  • Full FDA Coding and Reporting
  • Compensation Management

Laina Enterprises’ suite of products enable a “Lab to Life”
focus, from bench to market


Who Are We?

The industry veterans behind Laina Research PlatformTM have a proven track record in Clinical Trial Management and software innovation

Leveraging our hugely successful clinical trial software ventures, we are building Laina Research PlatformTM with the latest technology and industry insight

Bryan Silverman

President & CEO

For additional information contact

Bryan at: 1-732-533-7979 or