AI & Data Analytics Services
Intelligent & Integrated Clinical Data Management
Transforming clinical data operations from reactive oversight to intelligence‑driven execution.
Overview
Clinical trials today generate data at unprecedented scale and complexity a core challenge that digital transformation in life sciences is designed to solve, spanning EDC systems, CTMS platforms, safety databases, lab feeds, external CROs, and emerging real-world inputs. Despite significant investments in systems and process controls, clinical data management (CDM) often remains heavily manual, fragmented, and reactive focused on ‑late stage‑ clean‑up rather than continuous insight.
This experience addresses the structural limitations of traditional CDM models by re‑imagining clinical data management as an integrated intelligence layer rather than a downstream operational function. The focus shifts from isolated data checks to holistic, continuous monitoring of data quality, study health, and operational risk across the trial lifecycle.
What This Experience Enables
The experience creates a unified clinical data ecosystem where structured and unstructured data from multiple sources is harmonized, enriched, and monitored in near real time. By embedding analytics and machine learning into the data pipeline, deviations, anomalies, and quality risks are identified early—before they impact timelines, patient safety, or regulatory readiness.
Clinical data managers, clinical operations teams, and study leadership gain shared visibility into metrics that matter most, enabling early intervention and more predictable outcomes.
How It Works (Capabilities & Approach)
- Integration of EDC, CTMS, labs, safety, CRO, and external data sources.
- Data standardization and semantic enrichment.
- Continuous data quality monitoring using rules, statistics, and machine learning.
- Identification of recurring discrepancies, site‑level issues, and systemic risks.
- Risk‑based prioritization of data issues aligned to critical‑to‑quality variables.
- Portfolio‑, study‑, site‑, and subject‑level dashboards.
- Role‑based views for CDM, ClinOps, and oversight stakeholders.
Business Impact
- Improved data quality through early detection and prevention.
- Reduced data cleaning effort and rework.
- Shorter database lock and submission timelines.
- Greater predictability across multi‑study and multi‑CRO environments.
- Stronger alignment between data integrity and patient safety objectives.
A Core Data & Analytics Capability for Life Sciences
AI Driven‑ Site Intelligence & Selection capability enables Life Sciences organizations to design, launch, and manage clinical trials with greater speed, precision, and confidence by leveraging the power of advanced data engineering, AI/ML, and applied analytics.
Selecting the right countries, sites, investigators, and patient populations is a critical determinant of clinical trial success, and a key focus of Mastek’s IT solutions for life sciences practice. However, traditional approaches are often constrained by fragmented data, manual assessments, and retrospective decision making. Mastek addresses this challenge by creating an integrated, ‑intelligence led platform that transforms diverse clinical, operational, and real world data into actionable insights.
At the core of this capability is an AI‑based site scoring and recommendation engine built on a robust data foundation. The platform ingests and harmonizes data from:
- Historical clinical trial performance.
- Syndicated and commercial datasets (e.g., investigator and site intelligence).
- Therapeutic‑area patient population insights.
- Market, epidemiology, and regulatory data.
- Public clinical trial and healthcare data sources.
By applying advanced analytics, weighted scoring, clustering techniques, and continuous learning models, the platform evaluates and ranks sites across key dimensions including patient accessibility, investigator and site performance history, operational readiness, regulatory compliance, and cost efficiency.
A single lens into trial health, quality, and performance.
Overview
Clinical data review is fragmented across tools and roles, limiting visibility and slowing issue identification. Decision makers often lack a consolidated view of operational performance, patient trends, and data quality risks.
This experience delivers a single, integrated workspace for reviewing and acting on clinical data.
What This Experience Enables
The platform brings together operational KPIs, patient‑level signals, site performance, and quality indicators into one coherent analytics layer. Interactive dashboards support both executive oversight and detailed drill‑downs.
How It Works
- Unified data model across operational and patient data.
- Interactive dashboards with drill‑downs.
- Cohort and trend analysis.
- Site and country benchmarking.
- Collaboration and action tracking.
Business Impact
- Faster identification of risks.
- Improved collaboration across teams.
- Reduced manual reconciliation.
- Site and country benchmarking.
- Stronger governance and traceability.
A key differentiator of Mastek’s a leading digital solution for the life sciences industry is its multiagent AI architecture‑, where specialized intelligence agents independently analyze patient data, healthcare provider availability, epidemiology, market dynamics, competitive trials, and regulatory factors. These insights are orchestrated through an NLP enabled conversational interface, enabling users to ask intuitive business questions such as:
"Which sites should we select for this protocol?"
"Where are we most likely to see patient dropout risk?"
The platform responds with ranked recommendations, visual analytics, and explainable scorecards, ensuring trust, transparency, and governance.
The user experience is built for decision‑makers, with interactive dashboards, feasibility lists, heatmaps, and comparative visualizations that translate complex analytics into clear, executive‑ready insights—without replacing human expertise.
Business Impact
With an AI‑Driven Site Intelligence & Selection capability, Life Sciences organizations can:
- Accelerate trial start‑up timelines.
- Reduce patient dropout and site underperformance.
- Optimize resource allocation and site investments.
- Lower overall clinical trial costs.
- Build a sustainable, data‑driven foundation for future trials.
This capability reflects Mastek’s broader Data & Analytics practice strength—combining deep domain knowledge, modern data platforms, and applied AI to solve complex business problems and drive measurable outcomes.
Accelerating compliant content creation
Overview
Regulatory and medical authoring are constrained by tight timelines and increasing document complexity, a key area where Mastek's life sciences IT services deliver measurable efficiency gains. This experience enhances author productivity through intelligence and automation.
What This Experience Enables
AI‑assisted generation, semantic search, and reusable content libraries accelerate drafting while preserving governance.
How It Works
- NLP/NLG‑based content generation.
- Semantic search across historical documents.
- Template‑driven authoring workflows.
- Human‑in‑the‑loop review.
Business Impact
- Faster authoring cycles.
- Improved content consistency.
- Reduced SME effort.
- On‑time submissions.
Scaling safety operations with intelligence
Overview
AE case processing involves high volume, diverse formats, and strict compliance obligations, making it one of the most demanding areas for IT solutions for life sciences safety teams. This experience automates intake, triage, and monitoring while keeping humans in control.
How It Works
- NLP, OCR, speech‑to‑text.
- ML‑based signal detection.
- Guided safety workflows.
- Real‑time dashboards.
Business Impact
- Faster case processing.
- Improved compliance.
- Lower operational cost.
Overview
Medical Legal Review (MLR) is a critical but resource intensive function within life sciences digital transformation program, responsible for ensuring scientific accuracy, regulatory compliance, and legal integrity of promotional and scientific content. Mastek’s Agentic AI–enabled MLR solution transforms traditional, manual review processes into an intelligent, scalable, and ‑compliance‑bydesign‑ workflow.
The Challenge
MLR teams across Medical, Regulatory, Legal, and Commercial functions rely heavily on manual reviews to validate scientific claims, ensure fair balance, verify references, assess regulatory adherence, and perform quality checks. These processes are time‑consuming, repetitive, and prone to delays—leading to longer campaign launch cycles, higher operational costs, and reactive compliance risk management.
Our Data & AI‑Driven Approach
Mastek embeds a network of specialized AI agents across the MLR lifecycle, including Medical Review Agents, Regulatory Review Agents, Legal Review Agents, Content Agents, and Quality Check Agents. These agents leverage NLP, knowledge graphs, and large language models to analyze content contextually—across text, visuals, claims, references, metadata, and brand guidelines.
Business Impact & Outcomes
- Reduction in MLR review cycles from multiple rounds to 1–2 iterations.
- Faster time‑to‑market for compliant promotional and scientific content.
- Proactive identification of compliance, IP, and regulatory risks.
- Improved reviewer productivity through intelligent summarization and automation.
Scalable, audit-ready MLR process across geographies and channels.
Overview
Commercial and digital teams need real‑time visibility into brand performance, customer engagement, and marketing effectiveness. Mastek’s Insights Navigator combines advanced analytics with embedded GenAI to deliver intuitive, conversational, and actionable commercial intelligence.
The Challenge
Commercial performance data is often distributed across multiple digital and engagement platforms, making it difficult for teams to quickly identify trends, optimize spend, and respond to changing market dynamics.
Our Data & AI Solution
Insights Navigator integrates data from 30+ digital and commercial sources, enabling KPI tracking, LLM‑based chart insights, scenario planning, budget optimization, and conversational analytics through an “Ask Genie” chatbot.
Business Impact & Outcomes
- Faster insights into brand and campaign performance.
- Improved marketing ROI through data‑driven budget optimization.
- Self‑service analytics for business users with no training required.
- Scalable deployment across brands, regions, and personas.