AI-Powered Platforms for Pharma • Life Sciences • MedTech (P3)

AI-Powered Platforms for Pharm 21.08.2025

AI-Powered Platforms for Pharma • Life Sciences • MedTech (P3)

GHIT Digital’s POV

Understanding P³: Pharma, Life Sciences & MedTech

The P3 sector of HealthCare encompasses organizations that invent, test, produce, and commercialize therapies, diagnostics, and medical devices. It is highly regulated and data-intensive:

Pharma/Biopharma: Drug discovery → preclinical → clinical trials → regulatory submissions → manufacturing/QMS → pharmacovigilance → medical/commercial operations.
Life Sciences: CROs, CMOs/CDMOs, labs—focused on R&D, platform biotech, and manufacturing services.
MedTech/Devices: Device design → clinical evaluation → FDA/CE approval → manufacturing/QMS → post-market surveillance.

Key departments & workflows

Domain	Core Activities
R&D & Clinical	Protocol design, feasibility, site start-up, CTMS operations, EDC/CDMS, randomization (RTSM), eCOA/ePRO, data cleaning, medical coding, eTMF
Regulatory Affairs	Health authority interactions, RIM, eCTD submission, labeling, promotional review
Quality & Compliance (GxP)	GLP/GCP/GMP oversight, QMS/CAPA, CSV/Part 11, audits
Manufacturing & Supply	Tech transfer, MES/LIMS/QMS, batch release, serialization, cold chain logistics
Medical Affairs	Scientific content, MSL engagement, RWE generation, medical information
Commercial/Market Access	CRM, omnichannel engagement, MLR review, payer strategy, field service
Finance/Revenue Cycle	Coverage analysis, charge segregation (sponsor vs. payer), claims edits, sponsor invoicing, receivables, audits
Data/AI & Interoperability	Master data management (HCP/HCO/product/site), FHIR-based EHR integration, lakehouse analytics, governed AI

Compliance frameworks: ICH E6(R2), GCP, FDA regulations, HIPAA, Medicare Clinical Trial Policy (NCD 310.1), Q0/Q1 claim modifiers.

The Technology Landscape for P3

Clinical Operations Platforms (CTMS)

OnCore: Study lifecycle, billing compliance, financial tracking
Veeva Vault CTMS: Operational efficiency, real-time insights
Huron Click: Streamlined clinical workflows
SignalPath (Verily): Site insights and monitoring

Data Capture & Data Management (EDC/CDMS)

Medidata Rave, Oracle Clinical One, Veeva Vault EDC, OpenClinica, Castor, Medrio
Supports SDTM/ADaM standards for FDA submission

Trial Master File & Content (eTMF / Regulated Content)

Box GxP Validation + Box Sign for Part 11 e-signatures
Supports audit readiness and remote site monitoring

Regulatory & Submissions (RIM / eCTD)

eCTD submissions, regulatory content tracking, audit-ready evidence

Safety / Pharmacovigilance

Case intake, signal detection, E2B(R3) reporting, integration with EDC and medical info systems

Lab, Quality & Manufacturing

LIMS/MES/QMS for batch records, deviations/CAPA, releases, GxP compliance

Commercial & Medical

Salesforce Life Sciences Cloud (clinical, medical, commercial)
Veeva PromoMats for MLR review and digital asset management

Interoperability & eSource

FHIR/eSource integration reduces transcription, improves data flow, supports regulatory compliance

Clinical Trial Billing & Charge Monitoring

Every charge must be accurately routed:

Sponsor: Investigational or study-specific services
Insurer: Routine clinical care

Challenges:

Complex mapping: IRB-approved protocols, coverage analysis, consent, site calendar, Q0/Q1 modifiers
Manual review is error-prone → delayed invoices → audit risk

AI & Low-Code Solution

Pattern recognition to flag misrouted charges
Explainable AI for compliance evidence
Automated sponsor invoice generation
Dashboard for audits and regulatory reporting

GHIT Digital’s AI-Powered Low-Code Approach

Why GHIT Digital?

Rapid deployment: Low-code accelerates integration with existing CTMS/EDC/CRM
Cost efficiency: Reduces custom development and maintenance
Scalability: Supports growing trial volumes
Compliance-first: Enforces regulatory requirements across GxP, HIPAA, NCD 310.1

Platform Integration Example

Layer	System	GHIT Digital Role
Clinical Ops	OnCore / Veeva / Huron / SignalPath	Process orchestration, AI-assisted charge review
EDC/CDMS	Medidata Rave / Vault EDC	Query automation, data lock workflows
Billing	Epic/Cerner/Athena	Billing copilot, reconciliation, Q0/Q1 routing
Regulatory	RIM/eCTD	Submission prep, evidence tracking
Commercial	Salesforce LSC / PromoMats	MLR automation, omnichannel engagement
Content & Signatures	Box GxP + Box Sign	Regulatory-compliant e-signatures and audit trails
Data & AI	Lakehouse / Governed AI	Predictive analytics, anomaly detection, ML workflows

Delivery Steps

Discover: Map processes, policies, data lineage
Design: Target journey, SLAs, KPIs
Build: Low-code apps, AI workflows
Validate: CSV/Part 11 compliance, audit readiness
Deploy: Pilot, scale, hypercare
Improve: Continuous optimization with AI feedback

Real-World Impact

Billing Accuracy: ≤1% misrouted charges, 95% first-pass acceptance
Operational Efficiency: Study start-up cycle time ↓ 25–40%
Commercial Efficiency: MLR cycle ↓ 35%, improved content reuse
Audit-Ready Compliance: NCD 310.1, HIPAA, Part 11, GCP alignment

GHIT Digital bridges existing technology platforms with low-code, AI-powered orchestration, delivering measurable impact across P³.

Looking Ahead

The P3 sector of HealthCare is moving toward AI-integrated, low-code platforms to achieve agility, compliance, and operational excellence. GHIT Digital is positioned as a strategic partner for organizations seeking seamless, scalable, and regulatory-compliant solutions.

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