Our Services

Comprehensive clinical data, statistical, and digital transformation solutions — delivered by specialists, on time, every time.

Clinical Data Management

Our CDM services cover the complete lifecycle of clinical trial data — from study startup through database lock. We ensure data integrity, regulatory compliance, and on-time delivery across all study phases and therapeutic areas.

  • CRF / eCRF Design & Development
  • Database Design, Build & UAT
  • Edit Check Programming
  • Data Entry, Validation & Cleaning
  • Query Management & Resolution
  • SAE Reconciliation
  • Database Lock & Archive
  • Data Management Plan (DMP) Development

EDC Expertise: Medidata Rave, Veeva Vault CDMS, Medrio, Zelta EDC, Oracle InForm, Oracle Clinical, ClinCapture, iMednet, Viedoc, REDCap and more.

CDM

Biostatistics & Statistical Programming

Our statistics and programming team provides rigorous support across all clinical trial phases — from protocol design through regulatory submission. Deep biostatistical knowledge, combined with hands-on SAS and R programming expertise.

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Biostatistics

  • Statistical Analysis Plan (SAP) development
  • Sample size & power calculations
  • Randomisation & blinding
  • Interim & final statistical analysis
  • Protocol design support
  • Regulatory submission support
  • Mock shell development
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Statistical Programming

  • SDTM & ADaM dataset programming (SAS/R)
  • TLF (Tables, Listings & Figures) generation
  • TLF review & quality control
  • Define.xml & cSDRG creation
  • SAP implementation & updates
  • Dry run support
  • DBL & post-DBL programming
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Submission Support

  • NDA / BLA / IND submission packages
  • Pinnacle 21 validation
  • FDA Technical Conformance compliance
  • Reviewer's Guide (RG) development
  • Sponsor comment incorporation
  • Protocol amendment support

SDTM / CDISC Standards

We deliver complete CDISC submission-ready datasets including SDTM, ADaM, and associated define.xml documents — ensuring full compliance with FDA, EMA, and PMDA requirements.

  • SDTM Mapping & Dataset Creation
  • ADaM Dataset Development
  • Define.xml & Reviewer's Guide
  • Pinnacle 21 Validation
  • CDASH Implementation
  • NDA/BLA/IND Submission Support
  • Controlled Terminology Management
CDISC

Medical Writing

Our medical writers produce scientifically accurate, regulatory-compliant documents that support clinical development and regulatory submissions — written with clarity and precision.

  • Clinical Study Reports (CSR)
  • Study Protocols & Amendments
  • Investigator Brochures (IB)
  • Informed Consent Forms (ICF)
  • IND / NDA / BLA Submission Documents
  • Scientific Publications & Manuscripts
  • Summary of Clinical Safety / Efficacy
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Pharmacovigilance

Our pharmacovigilance team supports safety data management and reporting throughout the clinical lifecycle — ensuring compliance with global safety reporting requirements.

  • SAE / SUSAR Collection & Processing
  • Safety Database Management
  • SAE Reconciliation (EDC ↔ Safety DB)
  • Expedited & Periodic Safety Reporting
  • Signal Detection & Management
  • PV SOP Development
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Digital Transformation Consulting

We help pharma, biotech, and healthcare organisations navigate complex digital change — accelerating modernisation while protecting compliance, quality, and continuity.

Digital Design & Delivery

  • Digital platform strategy & roadmapping
  • Modern tech stack design & implementation
  • Legacy system migration & modernisation
  • Cloud-native architecture & deployment
  • Agile / DevOps delivery

Process Improvement

  • End-to-end process mapping & analysis
  • Workflow redesign & optimisation
  • Intelligent automation of manual tasks
  • KPI frameworks and performance dashboards
  • Continuous improvement programmes

Mobile & Web Applications

  • Custom web application development
  • Mobile app design & build (iOS/Android)
  • React Native & Flutter development
  • User experience (UX) design
  • API integration & third-party connectivity

Managed Services

  • Cloud infrastructure management (AWS/Azure)
  • Application monitoring & support
  • Security & compliance management
  • SLA-based service delivery
  • Disaster recovery & business continuity

AI Integration & Intelligent Automation

We embed AI into the heart of your operations — not as a proof of concept, but as production-grade capability that drives measurable business value.

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AI Integration & Orchestration

  • Large Language Model (LLM) integration
  • AWS Bedrock, Azure ML, Google AI Platform
  • AI-assisted clinical data review
  • Natural language processing for documents
  • Predictive analytics & signal detection
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Intelligent Process Automation

  • RPA (Robotic Process Automation)
  • End-to-end workflow automation
  • Smart document processing
  • Automated data reconciliation
  • Compliance monitoring automation
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Data & Decision Intelligence

  • Business intelligence & analytics dashboards
  • Real-time data monitoring tools
  • AI-powered quality review
  • Intelligent decision support systems
  • Risk-based monitoring (RBM) frameworks

Project & Program Management

Experienced project and program managers overseeing the full delivery — ensuring on-time execution, quality, and seamless sponsor and stakeholder communication at all times.

  • Study startup & kick-off management
  • Timeline & milestone tracking
  • Risk identification & mitigation planning
  • Cross-functional team coordination
  • Sponsor status reporting & governance
  • Post-production & submission support
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Need a Custom Solution?

Our team will design a tailored service package that fits your study requirements, project goals, and budget.

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