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IT Solutions
Statistical Programming & Biostatistics
Our experienced Statisticians and Statistical Programmers help our customers in analysis of clinical trials of all types including parallel, crossover, multi-phase and PK/PD studies. Our statisticians and programmers are committed to follow SOPs and ICH guidelines. We are flexible in producing reports in sponsor-defined templates or using our standard templates.
Our biostatistics and programming services include:
— Statistical inputs to protocol development
— Sample size calculation
— Randomization schemes
— Independent Statisticians
— Statistical Analysis Plan
— CDISC SDTM mapping and conversion
— Generation of Analysis Data in ADaM data model
— TLF programming for analysis and reporting of clinical trial data
— Interim Analysis for DMCs and DSMBs
— PK/PD Analysis
— Pooled/Integrated Analysis (ISS and ISE)
— Analysis for Real World Evidence
Statistical Programming
Data Management
Clinical Software Development
Our highly skilled developers bring to the fore in-depth IT expertise that extends across various platforms and domains, providing you with turnkey assistance to execute your end-to-end application design needs at lesser costs and with shortened development cycles.
IT Consulting Services
Enterprise Mobility Solutions, Enterprise Application Architecture, Dedicated Development Center
Software Services
Web Application Development, Custom CRM & ERP Development, Product Development, Application Migration & Modernization
Collaboration Solutions
E-Commerce Solutions, Business-Enterprise Content Management, Portal Development, Enterprise Document Management
Enterprise Packaged Solutions
SharePoint, Sales Force, Google Apps Development
Mobile Application
iOS/Android Mobile App Development
Software Development
Data Management
Our dedicated Data Management team ensures the integrity and accuracy of clinical trial data throughout the study lifecycle. We implement robust data collection and validation processes to uphold data integrity and reliability. Our commitment to SOPs and ICH guidelines guarantees compliance and quality, and we offer customizable reporting solutions tailored to meet sponsor requirements.
Study Start-up
— Input to protocol design
— Project Planning
— Creation of Data Management Plan and
Data Validation Plan
— CRF/eCRF Design
— Database Design and Edit Check Programming
— Database Testing and UAT
— Data Migration
Study Conduct
— Data Review and Query Management
— External Data Management
— SAE Reconciliation
— Medical Dictionary Coding
— Quality Control Activities
— Telemedicine
— Remote Monitoring
— ePRO
— eDiary
Study Closure
Pharmacovigilance
We have an extensive experience delivering end-to-end services in the area of Pharmacovigilance KPO. Our PV KPO practice has rich experience of handling annual volumes of more than 100,000 cases.
We ensure metrics-driven delivery of business processes from strategic global delivery locations.
Our PV KPO Services include:
— End-to-end Adverse Event case processing: Case intake and triage, quality control and medical reviews
— Case Analysis and Reporting (DSURs, PSURs, Aggregate, custom reports
— Drafting PSURs and Addendum reports, generation of line listings
— Appendices preparation and publishing as well as regulatory submission
— Scientific Literature Surveillance
— Reconciliation of PV database with clinical database
— Population Studies & Pharmaco-epidemiology Assessment
Pharmacovigilance
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