OmniComm Systems

-Viral

Presentation of Course-EDC for clinical trialUCSC Extension

Introduction

• OmniComm is a web-based healthcare technology solution company provides EDC and services to ph’ceuticcal , 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

ContinueSafety 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 Dec’07($ 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.