clinicaldatamanagement

Xertz provides excellent data management solutions for Phase 1 – IV clinical trials by leveraging technology, robust processes and well qualified resources in wide range of therapeutic areas. Our CDM team provides cost effective end to end services from database build to lock through customized support to our clients. Our clients value us for the uncompromised approach and various advantages..

  • High standards & reliable data
  • Data integrity
  • Quality management
  • Excellent turn around
  • Transparent results

Our CDM services:

  • CRF and eCRF designing
  • Database set up – Build, design and programming
  • Project management & Protocol review
  • Data entry & Validation
  • Discrepancy Management
  • External Data Handling (SAE,labs, device data, etc)
  • AE/Con Med/Disease coding
  • Quality Review & reconciliation
  • Lock, Archival & documentation/ Data Migration.
  • Security and Safety of datamanaged as per 21 CFR part11

Therapeutic Areas:

  • Neurology
  • Oncology
  • Ophthalmology
  • Cardiovascular
  • Dermatology
  • Hematology
  • Infectious Diseases
  • Urology
  • Respiratory
  • Endocrinology, etc.,

Expertise:

  • Best in class team.
  • Over 10 years of experience in the areas of Clinical Data Management, Pharmacovigilance/Drug Safety and Medical Writing.
  • Security and Safety of data managed as per Regulatory standards (Part 11, HL7, etc).
  • Expertise in Oracle Clinical, Inform, Medidata Rave, WHODD, MedDRA, etc.,
  • 6 years of average experienced professionals as trainers, supervisors and Project leads.
  • Coders experienced in working on multiple coding platforms.