Data Management

SIRO Clintech Data Management

SIRO: Your Catalyst Partner for
Clinical Trial Data Management Services


In the dynamic realm of clinical research, SIRO is a leading provider of Clinical Data Management (CDM) services that combine expertise, innovation and commitment to enable groundbreaking medical discoveries. SIRO’s focus on excellence and precision in CDM services assists in navigating through the intricacies involved in the clinical trial data management process thus ensuring seamless handling as well as integration of vital trial data. Our approach is all inclusive, it spans from collection to validation of data while catering for various needs among our clients.

Clinical Data Management Services:
What Sets Us Apart?

Task Based Approach

  • Medical Coding using latest versions of MedDRA and WHODrug dictionary
  • Data Anonymization
  • CRT validation
  • Data validation
  • GCDMP compliant robust SOPs

Experience and Expertise

  • Deep CDM Expertise: 16+ years of experience
  • EDC Agility: Proficient in managing any EDC application
  • Study Versatility: Expertise in PDC, EDC, and hybrid studies

Subject Diary

  • Design of Paper/e-Diary (eCOA)
  • Seamless integration of eCOA with EDC platform
  • Improves subject monitoring and safety through real time reporting

IP Management

  • Set up randomization functionality/IWRS with EDC
  • Ensure optimized, streamlined supply chains
  • Uninterrupted integration with EDC, CDMS systems and eCOA solutions​

RBM

  • Data visualization/dashboards
  • Easy analytics
  • Exploration of data

Our Milestones

  • First Data Services team to initiate (FTE-FSP) outsourcing in India.
  • Comprehensive approach covering end-to-end activities in clinical data​​base management services.
  • Established presence as distinguished speaker at Society for Clinical Data Management services (SCDM) conferences.
  • Specialized trainings designed for Pharma/Biotech companies to impart insights and best practices in clinical trial data management.

Medical Coding by Medical Experts

Dedicated coding engagement

Setup & Scope

  • Medically qualified professionals
  • Experienced in most TAs & industry standard dictionaries
  • Medical Coding of AE, CM, MH using MedDRA, WHODrug, Legacy dictionaries
  • QC of terms coded by other CROs

Cost & Quality

  • 30 % cost benefits
  • Minimum supervision
  • Remote working
  • Error rate < 0.05 % across FTE & transactional models
  • TAT met at all times

Value Additions

  • 1 day turn around time
  • Daily task completion across geographies & studies
  • Internal coding repository maintained, shared with clients
  • Participation as expert review panel at UMC user group conference
  • Valuable contribution for dictionary upgrades to MSSO and UMC
  • Prior & Latest versions of dictionaries available

Results / Outcomes

  • 2 million terms coded