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    Registries and Post-Approval Studies

Registries and Post-Approval Studies

We combine industry-specific expertise and services to produce the real-world evidence you need to meet your scientific and commercial objectives.

Late-phase studies and registries require unique capabilities from an EDC system. OmniComm TrialMaster has the flexibility and scalability to support all types of late-phase studies, from disease registries to long-term observational studies or any type of post marketing comparator studies. A growing list of drug and disease registries, some with more than 600 sites and 40,000 patients make OmniComm TrialMaster the right choice for late phase.  OmniComm’s SaaS and license pricing models are sensitive to the budgets of late-phase trials and we offer competitive monthly fees on long trials and scalable pricing on large enrolling registries.

OmniComm TrialMaster meets the needs for late-phase, post-approval studies by:

  • Designing studies with a flexible or unplanned visit structure
  • Creating unscheduled events
  • Supporting electronic patient reported outcomes
  • Easily obtain data extracts anytime during the course of the study
  • Integrated eLearning for just-in-time initiation, training, and refresh tool
  • SafetyLink, AutoEncoder, Notifications and Data Grids to support the time-critical needs of pharmacovigilance
  • Responsive database architecture to support very large data volume
The EDC Technology for Post-Approval Studies

Prior to the start of your next late-phase study, compare your checklist with ours and let us show you why TrialMaster has been chosen by many organizations as their late-phase electronic data capture of choice:

  • Simple electronic CRF system that minimizes edit checks
  • User-driven process for selecting the right CRFs for each patient assessment
  • Dynamic calendar features for building patient-specific schedules and reminders
  • Support for paper and electronic CRFs
  • On-demand access to all clinical data and reports for analysis
  • Flexibility to add patient assessment/encounter at any time
  • Easy-to-use online help and eLearning system

Our late-phase solution is uniquely positioned to address these key areas:

  • Post-authorization safety studies (PASS) / Post-authorization efficacy studies (PAES)
  • Risk evaluation and mitigation studies (REMS)
  • Phase IV trials — approved product, same indications (interventional)
  • Registries — disease, product and safety (observational)
  • Community-based and naturalistic studies

Contact Us      North America +1 877.468.6332      Europe +49 (0) 228 227 440      Click Here to Email Us

Contact Us
North America
+1 877.468.6332
+49 (0) 228 227 440
Click Here to Email Us