Our Services

Comprehensive clinical data and statistical solutions — delivered by experts, on time, every time.

Clinical Data Management

Our CDM services cover the full lifecycle of clinical trial data — from study startup through database lock. We ensure data integrity, regulatory compliance, and timely delivery across all 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, and more.

CDM

Biostatistics & Statistical Programming

Our statistics and programming team provides rigorous support across all phases of clinical trials — from protocol design through regulatory submission. We combine deep biostatistical knowledge 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 & QC
  • Define.xml & cSDRG creation
  • SAP implementation & updates
  • Dry run support
  • DBL & post-DBL programming support
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Submission Support

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

SDTM / CDISC Standards

We provide complete CDISC submission-ready datasets including SDTM, ADaM, and associated define.xml documents, ensuring 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 high-quality, scientifically accurate, and regulatory-compliant documents that support clinical development and regulatory submissions.

  • 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 trial 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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Project & Program Management

We provide experienced project and program managers who oversee the full clinical data operations — ensuring on-time delivery, quality, and seamless sponsor communication.

  • Study startup & kick-off management
  • Timeline & milestone tracking
  • Risk identification & mitigation
  • Cross-functional team coordination
  • Sponsor status reporting
  • Program-level oversight & governance
  • Post-production & submission support
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CRO Setup for Startup Companies

Starting a new pharma or biotech company and need to build clinical data operations from scratch? We help startup sponsors and emerging CROs set up their clinical research infrastructure quickly and compliantly.

  • CRO operational setup & process design
  • SOP development from scratch
  • EDC platform selection & implementation
  • Staffing with skilled clinical resources
  • Regulatory compliance framework
  • Quality management system setup
  • Training of new clinical staff
Talk to Our Experts

Why Startups Choose Us

We understand the challenges of building clinical operations from the ground up. Our team has helped multiple startup sponsors establish fully functional, audit-ready clinical data and statistics operations — faster than going it alone.

Fast
Setup Time
End-to-End
Support

More Services

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Global Standard Libraries

  • CDISC Controlled Terminology
  • Coding dictionaries (MedDRA, WHODrug)
  • Standard edit checks library
  • Global SAP & TLF templates
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SOPs & Process Documentation

  • SOP development & review
  • Regulatory-compliant templates
  • Work instruction creation
  • SOP training & implementation
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Risk Based Monitoring

  • RBM strategy development
  • KRI selection & thresholds
  • Central monitoring setup
  • RBM tool implementation

Need a Custom Solution?

Our team will design a service package that perfectly fits your study requirements and budget.

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