Our Services

All Services

Click a Service to View Details

Clinical Data Management & EDC

Study startup, eCRF design, data cleaning, UAT and database lock

▼ View Details

Biostatistics

SAP development, statistical analysis and submission support

▼ View Details

Statistical Programming

SDTM, ADaM, TLFs, Define.xml and submission packages

▼ View Details

Medical Writing

CSRs, IBs, regulatory summaries and submission documents

▼ View Details

IT Services & AI Capabilities

Digital transformation, AI automation and ISO certifications

▼ View Details

Quality Assurance & SOPs

ICH-GCP SOPs, QC frameworks and regulatory compliance

▼ View Details

Consultation

Expert strategic guidance for clinical data and statistics challenges

▼ View Details

Project & Program Management

Study governance, milestone planning and delivery assurance

▼ View Details

Global Standard Libraries

Pre-built validated macro libraries for SDTM, ADaM and TLFs

▼ View Details
Service 01

Clinical Data Management & EDC Services

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

Study Start-up

Protocol to deployment

  • Protocol Interpretation & DMP
  • eCRF Design & Development
  • Database Build & UAT
  • Edit Check Specification & Programming
  • CDISC CDASH Implementation
  • Risk-Based Data Management Planning
  • Metadata Management

EDC Services

Multi-platform expertise

  • EDC System Selection Advisory
  • Platform Configuration & Setup
  • Study Build & Validation
  • User Training & Support
  • Post-Production Maintenance
  • Cross-Platform Migration
  • EDC Integration Support

Study Conduct

Ongoing data operations

  • Ongoing Data Cleaning & Query Management
  • SAE Reconciliation
  • External Data Reconciliation
  • Data Listings Review
  • Medical Coding
  • Real-Time Monitoring Dashboards
  • Data Visualization & Reporting

Study Closeout

Lock to submission

  • Final Data Review & Database Lock
  • Database Unlock / Re-lock
  • EDC Archival
  • Define.xml & Reviewer's Guides
  • Annotated CRFs
  • Submission-Ready Data Packages
EDC Platform Expertise
Medidata Rave  ·  Veeva Vault CDMS  ·  Medrio  ·  Zelta EDC  ·  Oracle InForm  ·  ClinCapture  ·  iMednet  ·  Viedoc  ·  Oracle Clinical  ·  PICTS  ·  Clinform
Service 02

Biostatistics

Our biostatistics team provides rigorous support across all phases — from protocol design through regulatory submission — combining deep statistical knowledge with regulatory expertise.

SAP & Study Design

  • Statistical Analysis Plan (SAP) development
  • Sample size & power calculations
  • Randomisation & blinding
  • Protocol design support
  • Mock shell development
  • Adaptive trial design support

Statistical Analysis

  • Interim & final statistical analyses
  • Exploratory & confirmatory analyses
  • Safety & efficacy reporting
  • Data review & validation
  • DSMB / IDMC support
  • Benefit-risk assessments

Submission Support

  • NDA / BLA / IND submission packages
  • Regulatory submission support
  • FDA, EMA, PMDA alignment
  • Reviewer's Guide development
  • Protocol amendment support
  • Regulatory query responses
Service 03

Statistical Programming

Our programming team delivers high-quality SDTM and ADaM datasets, TLFs, and submission packages using SAS and R — fully aligned with FDA, EMA, and PMDA requirements.

SDTM Programming

  • SDTM dataset programming (SAS / R)
  • SDTM mapping & annotation
  • Controlled Terminology Management
  • CDASH to SDTM conversion
  • SDTM implementation guidelines

ADaM Programming

  • ADaM dataset development (SAS / R)
  • ADSL, ADAE, ADLB, ADTTE & more
  • SAP implementation & updates
  • DBL & post-DBL programming support

TLF Generation & QC

  • Tables, Listings & Figures generation
  • TLF review & independent QC
  • Dry run support
  • Mock TLF shell development
  • TLF specifications development

Submission Deliverables

  • Define.xml & cSDRG creation
  • Pinnacle 21 validation
  • NDA / BLA / IND submission packages
  • Reviewer's Guide development
  • aCRF development
Service 04

Medical Writing

Our medical writers produce high-quality, scientifically accurate, and regulatory-compliant documents supporting clinical development and regulatory submissions.

Regulatory Documents

  • Clinical Study Reports (CSR)
  • Study Protocols & Amendments
  • Investigator Brochures (IB)
  • Informed Consent Forms (ICF)
  • Pharmacy Manuals

Submission Documents

  • IND / NDA / BLA submission documents
  • Summary of Clinical Safety (SCS)
  • Summary of Clinical Efficacy (SCE)
  • Scientific publications & manuscripts
  • Patient narratives

Post-Approval Support

  • Responses to regulatory queries
  • Label development & review
  • Risk Management Plans (RMP)
  • Post-approval documentation
  • Periodic Benefit-Risk Evaluations
Service 05

IT Services & AI Capabilities

We combine clinical domain expertise with modern digital capability — helping life sciences organisations modernise through intelligent automation, AI-driven insights, and end-to-end technology transformation.

Digital Transformation

  • Digital platform design & delivery
  • End-to-end process improvement
  • Mobile & web application development
  • Managed services & hosting

AI & Automation

  • AI integration & orchestration
  • Intelligent automation (RPA / AI)
  • AI-driven analytics & insights
  • Python, AWS Bedrock, Azure ML

System Integration

  • API development & integration
  • Clinical system interoperability
  • EDC & CTMS integration
  • Data pipeline automation

Certifications & Compliance

  • ISO 9001:2015 implementation support
  • ISO 27001 information security
  • 21 CFR Part 11 compliance
  • Quality Management System setup
Service 06

Quality Assurance & SOPs

Our QA services ensure your clinical data operations meet the highest standards of regulatory compliance and data integrity — from SOP development through audit readiness.

SOPs & Documentation

  • SOP development from scratch
  • SOP review & updates
  • Work instruction creation
  • SOP training & implementation
  • Template library management

Quality Control

  • Built-in QC at every stage
  • Independent QC programming
  • Data validation & reconciliation
  • Audit trail management
  • 21 CFR Part 11 compliance

Regulatory Standards

  • ICH E6(R2) GCP alignment
  • CDISC standards compliance
  • FDA Technical Conformance Guide
  • EMA Data Standards
  • CAPA & continuous improvement
Service 07

Consultation Services

Whether you're a startup pharma company or an established sponsor — our consultants provide expert guidance in clinical data management, biostatistics, statistical programming, and regulatory compliance.

Clinical Data Management

  • EDC system selection & setup
  • DMP development
  • Database design review
  • Process optimisation
  • Team structure & resourcing

Biostatistics & Statistical Programming

  • SAP strategy & development
  • Statistical methodology review
  • TLF strategy & submission readiness
  • SAS / R programming consultation

Risk Based Monitoring

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

Pharmacovigilance

  • Safety database setup
  • SAE reconciliation processes
  • Signal detection strategies
  • SUSAR reporting workflows

eCRF / EDC Technical

  • Medidata Rave configuration
  • Veeva Vault CDMS setup
  • Edit check logic review
  • UAT planning & execution

CRO Setup for Startups

  • End-to-end CRO infrastructure
  • SOP development from scratch
  • Staffing & resource planning
  • QMS implementation
Service 08

Project & Program Management

Study Governance

  • Study startup & kick-off management
  • Cross-functional team coordination
  • Sponsor communication & reporting
  • Issue & risk escalation

Timeline & Delivery

  • Timeline & milestone tracking
  • Risk identification & mitigation
  • Resource allocation & management
  • Regular status reporting to sponsors

Post-Production Support

  • Post-DBL & submission support
  • Regulatory response coordination
  • Protocol amendment management
  • Archive & closeout activities
Service 09

Global Standard Libraries

Our pre-built, validated macro libraries accelerate SDTM, ADaM, and TLF programming — reducing timelines and ensuring consistency across studies.

SDTM Libraries

  • Pre-built SDTM domain macros
  • Controlled terminology utilities
  • Validation & QC macros
  • Customisable to study-specific needs

ADaM Libraries

  • ADSL, ADAE, ADLB, ADTTE macros
  • Derivation utilities
  • Study-agnostic & reusable
  • Full validation documentation

TLF Libraries

  • Standard table & listing macros
  • Figure generation utilities
  • Output management systems
  • Submission-ready formatting
Let's Talk

Need a Custom Solution?

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

Request a Quote Submit RFI