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OmniComm Systems -Viral Presentation of Course-EDC for clinical trial UCSC Extension
Introduction OmniComm is a web-based  healthcare technology solution company provides EDC and services to phceuticcal , Biotech companies as well as Contract Research Organizations, Research Institutions and Medical Devices Companies. Its founded in 1997 and public company. NYSE Code : OMCM ($ 0.26)
Locations Headquarter in Fort Lauderldale,FL. Offices :- California,NY,NC,TX and Maryland. European Headquarter :- Germany
Management Cornelis F Wit,  CEO and President Randal G Smith Chairman Ronald T Linares Chief Financial Officer
Quality and Compliance US FDA : Title 21 CFR part 11 US FDA : Title 21 CFR Good Clinical Practices. US FDA GI : General principles of software validation ICH  Guidelines Clinical data interchange standards consortium (CDISC) and health level 7.
Expertise therapeutic area Addiction medication Cardiology Dermatology Urology Endocrinology Fitness Infectious Disease Nephrology Neurology Obesity  Oncology Ophthalmology Psychiatry Pulmonology Transplant Gastroenterology
TrialMaster v4.0 This software is a heart of OmniComm. TrialMaster allows sponsors and sites to easily and securely collects,validate,transmit and analyze clinical study data. TrialMaster offers much more than only EDC .it includes, Clinical Trial management systems, its allow better manage and support of clinical trial. Monitoring performance  PI performance Patient ,work flow and  Inventory management Safety management Document Library  Performance reporting Alerts and Email systems
Continue Safety support by allowing SAE tracking and reporting with MedWatch capabilities. A coding solution. Randomization solution.(both for patient enrolment and inventory ) Multi language study capability at different sites having same trial. Secure access by user specific login. Data importing is possible with prior testing facility.
Continue Protocol violations and deviations can be tracked by system ,referred as Bypass validation. TrialMaster contains robust standard reporting module. It facilitates easy to create reports includes summary reports, project status report, subject enrolment reports, subject status report, comments and queries by icrf,visit reports, SAE reports, Drug inventory reports etc.
Consulting Services OmniComm provides supports for EDC adoptions like project planning and management, on site training and support etc. Technology transfer support includes infrastructure planning, system validation planning etc. Custom reports and queries. CRF design factors for EDC EDC metrics SOP development
Financial OmniComm reported net income for Dec 08 was $ 10.5 Mn,more than double from financial year Dec07($ 5.2 Mn).
Training Provide each study with Companion Training Website. Also provides on site training, site specific training, investigator training and monitoring training etc.
Customers Mount Sinai medical center Optimer Target Research Associates KOS pharmaceuticals CRF-Clinical Research Facilities Apex Internationals Asthmatx Catalyst Pharmaceutical research Oxigene InChoir
Help Desk USA : Regular business hours in weekdays. 15 mins response time at rest of times(24*7*365) Europe : same as USA.
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Omni Comm Systems

  • 1. OmniComm Systems -Viral Presentation of Course-EDC for clinical trial UCSC Extension
  • 2. Introduction OmniComm is a web-based healthcare technology solution company provides EDC and services to phceuticcal , Biotech companies as well as Contract Research Organizations, Research Institutions and Medical Devices Companies. Its founded in 1997 and public company. NYSE Code : OMCM ($ 0.26)
  • 3. Locations Headquarter in Fort Lauderldale,FL. Offices :- California,NY,NC,TX and Maryland. European Headquarter :- Germany
  • 4. Management Cornelis F Wit, CEO and President Randal G Smith Chairman Ronald T Linares Chief Financial Officer
  • 5. Quality and Compliance US FDA : Title 21 CFR part 11 US FDA : Title 21 CFR Good Clinical Practices. US FDA GI : General principles of software validation ICH Guidelines Clinical data interchange standards consortium (CDISC) and health level 7.
  • 6. Expertise therapeutic area Addiction medication Cardiology Dermatology Urology Endocrinology Fitness Infectious Disease Nephrology Neurology Obesity Oncology Ophthalmology Psychiatry Pulmonology Transplant Gastroenterology
  • 7. TrialMaster v4.0 This software is a heart of OmniComm. TrialMaster allows sponsors and sites to easily and securely collects,validate,transmit and analyze clinical study data. TrialMaster offers much more than only EDC .it includes, Clinical Trial management systems, its allow better manage and support of clinical trial. Monitoring performance PI performance Patient ,work flow and Inventory management Safety management Document Library Performance reporting Alerts and Email systems
  • 8. Continue Safety support by allowing SAE tracking and reporting with MedWatch capabilities. A coding solution. Randomization solution.(both for patient enrolment and inventory ) Multi language study capability at different sites having same trial. Secure access by user specific login. Data importing is possible with prior testing facility.
  • 9. Continue Protocol violations and deviations can be tracked by system ,referred as Bypass validation. TrialMaster contains robust standard reporting module. It facilitates easy to create reports includes summary reports, project status report, subject enrolment reports, subject status report, comments and queries by icrf,visit reports, SAE reports, Drug inventory reports etc.
  • 10. Consulting Services OmniComm provides supports for EDC adoptions like project planning and management, on site training and support etc. Technology transfer support includes infrastructure planning, system validation planning etc. Custom reports and queries. CRF design factors for EDC EDC metrics SOP development
  • 11. Financial OmniComm reported net income for Dec 08 was $ 10.5 Mn,more than double from financial year Dec07($ 5.2 Mn).
  • 12. Training Provide each study with Companion Training Website. Also provides on site training, site specific training, investigator training and monitoring training etc.
  • 13. Customers Mount Sinai medical center Optimer Target Research Associates KOS pharmaceuticals CRF-Clinical Research Facilities Apex Internationals Asthmatx Catalyst Pharmaceutical research Oxigene InChoir
  • 14. Help Desk USA : Regular business hours in weekdays. 15 mins response time at rest of times(24*7*365) Europe : same as USA.