We are an integral part of Indivirtus Global CRO group of companies, where every service domain is led by group of experts to provide their quality, knowledge, and expertise. We offer end-to-end clinical research solutions across the globe including Clinical Trials (Phase I-IV), BA / BE studies, Clinical Endpoint studies, and clinical research solutions from PK studies in healthy volunteers to patient trials for generics and NCEs.
Clinical Data Management

Indivirtus takes pride in our data integrity and quality services as the keys in clinical Data management. We offer flexible and reliable services that ultimately breed clinical trial success. Our dynamic team of seasoned technical and clinical data managers, clinical programmers, coders, and lead data managers offers a wealth of experience spanning multiple therapeutic disciplines.

Indivirtus designs all clinical studies on validated electronic data capture (EDC) platforms in accordance with CFR Part 11 compliance standards to ensure not only robust clinical data collection but also its seamless validation, analysis, and presentation. Indivirtus strategy goes beyond routine processes to proactively identify and mitigate risks, ensuring smooth trial progression within specified timelines.

Specific clinical data management services include:
  • Electronic data capture (EDC) selection and end-user training
  • Data cleaning and query management
  • Data management and validation plans
  • Medical Coding and Drug Coding (MedDRA and WHO DDE)
  • Case report form (CRF) design in compliance with SDTM (Study Data Tabulation Model)
  • 24x7 Help Desk Support for sites
  • Database design in any industry EDC tools, e.g., Medidata RAVE)
  • Serious adverse event (SAE) management and reconciliation
  • Database Testing and User Acceptance Testing
  • Database Freeze and Lock
  • Data Validation Programming and Testing
  • Database Transfer in SAS XPT and EXCEL to relevant stakeholders
Biostatistics

Indivirtus offers biostatistics services for every stage of clinical trial and post-marketing phase. From study planning to delivery of final clinical study report, our expert biostatistician team is involved during all the following activities:

  • Adaptive protocol design and development
  • Statistical analysis plan (SAP) authoring
  • Sample size calculation and re-estimation (SSR)
  • IDMC plans
  • Randomization method and algorithm development
  • Independent Biostatistician for IDMC and regulatory interactions Determination of NI and equivalence margin
  • Clinical endpoint selection
  • Clinical study report (CSR) writing support
  • Statistical methodology recommendations as per ICH E9 R1
  • Tables, Listings, and Figures (TLF) mock-ups

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