 Frequently Asked Questions
OmniComm Systems, Inc:
- Give a brief history of your company including number of years in business.
- Describe your company’s approach to Quality (not strictly QA or QC, but Quality in general).
- What therapeutic areas do you have expertise in?
Application:
- What does an end-user require in order to access the system?
- What assurance is there that sites will be able to access TrialMaster through the internet?
- Can TrialMaster accommodate for global trials in multiple languages?
- Is there expected downtime to access the servers?
- Is the system 21 CFR Part 11 compliant?
- Are there security controls within the system?
- Does the system allow for passwords to expire?
Data Capture:
- How is data capture optimized through the use of TrialMaster?
- Does your product have edit checks? If so, give details.
- Can conditional forms and/or fields be created (e.g., if subject is entered as female, create pregnancy test form)?
Data Management:
- Does TrialMaster allow for importing of data from various sources?
- How can a user get raw data from the database? Is direct access available to your clients?
- Who retains ownership of the data?
- What kind of ad hoc reports are available? Are these reports able to be generated spontaneously by Sponsor staff or is your staff required to provide some service or intervention; and if so, what kind?
- Can protocol violations and deviations be tracked in the system?
- Is it possible to code Adverse Events and Concomitant Medications within TrialMaster?
- Can queries be generated within the system?
- Describe how data is locked.
- Are standard reports available with the system?
Clinical Trial Management:
- What CTMS functionality is available with TrialMaster?
Support/Services:
- Does OmniComm provide for customer support?
- How is training conducted?
Answers to Frequently Asked Questions
OmniComm Systems, Inc:
- Give a brief history of your company including number of years in business.
We are an Internet-based healthcare technology solutions company, founded in 1997. We provide Web-based electronic data capture (EDC) solutions and related value-added services to pharmaceutical and biotechnology companies, Clinical Research Organizations (CRO), academic research institutions and other clinical trial sponsors. TrialMaster, our Internet-based software application, allows clinical trial sponsors and investigative sites to easily and securely collect, validate, transmit and analyze clinical study data including patient histories, patient dosing, adverse events and other clinical trial information.
- Describe your company’s approach to Quality (not strictly QA or QC, but Quality in general).
OmniComm has adopted an environment of continuous improvement and prides itself in developing quality products and services. We benchmark ourselves against the industry's most successful companies and then determine how we can make our products better and services more efficient. There are 3 attributes that contribute greatly to this:
- Hiring the best and brightest people with varying industry experience.
- Listening to our current customer base on best practices and lessons learned and incorporating these into our current practices.
- Using technology to test and monitor quality.
- What therapeutic areas have you had expertise with?
- Addiction Medicine
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- Cardiology
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- Dermatology
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- Endocrinology
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- Fitness
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- Gastroenterology
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- Infectious Disease
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- Nephrology
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- Neurology
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- Obesity
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- Oncology
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- Ophthalmology
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- Psychiatry
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- Pulmonology
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- Transplant
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- Urology
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Application:
- What does an end-user require in order to access the system?
The TrialMaster application does not require sponsors, investigator sites and other application users to install software or purchase special hardware. All you need is a PC or laptop, Internet Explorer 5.0 or better, a connection to the Internet and a password.
- What assurance is there that sites will be able to access TrialMaster through the internet?
OmniComm has experience implementing sites in all continents where clinical trials are conducted. Site surveys are sent to each site that will use TrialMaster and our technical support team will work with you for suggesting a resolution for potential issues. In the event that a site does not have an internet connection, TrialMaster can be used in an offline capability with resynchronization with the study server utilizing a secure, encrypted file transmission consisting of only changed elements.
- Can TrialMaster accommodate for global trials in multiple languages?
TrialMaster has the flexibility to create a multi-language study where the iCRF questions at a site are in a different language. For example, if a site wants the iCRF questions in Japanese and another site wants the iCRF questions in Spanish for the same trial, this can be accommodated in TrialMaster with translation done by a medical translation expert. The roles established within TrialMaster assure the site personnel access the correct iCRFs.
- Is there expected downtime to access the servers?
We have experienced 99.99% up-time utilizing our systems design and server architecture since 1998.
- Is the system 21 CFR Part 11 compliant?
The system is fully compliant with both 21 CFR 11 and ICH guidelines. Additionally, the system is fully validated. We would welcome you to review our documentation.
- Are there security controls within the system?
All users are required to enter a unique username and password to access the system. The client determines how often passwords expire. User roles and groupings are set up and administered by client designees who are given administration rights to the system. Data is passed to the application from the client utilizing 128 bit SSL encryption.
- Does the system allow for passwords to expire?
This is defined by the client through the administration module.
Data Capture:
- How is data capture optimized through the use of TrialMaster?
Data is entered through a web browser. Data is dual-validated: At point of entry and at point of posting to server. Whenever possible, radio buttons, check marks, drop-down boxes, calendar and clocks are used to speed data entry and screens are designed for logical workflow. Diagrams may be scanned for easy reference during data entry.
- Does your product have edit checks? If so, give details.
Yes – If the data exists in the system on any form (cross form capabilities) and logic can be defined that results in a yes/no decision on the edit check, we can implement the edit. Edit checks routinely fire upon entry into a field but checks can also be set up to fire upon submission of the form. The system can also provide "Warning/Reminder Messages” upon submission of a form. The error message shown is defined by the customer.
- Can conditional forms and/or fields be created (e.g., if subject is entered as female, create pregnancy test form)?
Yes.
Data Management:
- Does TrialMaster allow for importing of data from various sources?
The Import setup has the functionality to test all files prior to importing into TrialMaster. TrialMaster then creates a test log file to identify where the errors occurred, if any. There are several options for processing this information.
1. The errors can be sent to the data provider for correction.
2. The Sponsor has the option to determine if:
a. all data is imported with errors
b. only data is imported without errors
c. they want to reject the whole file
Reports for this process are defined by the Sponsor and can be viewed in the TrialMaster Reports.
- How can a user get raw data from the database? Is direct access available to your clients?
The standard export or custom exports are available. Direct access to the export is available to the customer. He/she “requests” the export (on the system) and the system automatically creates the export file over night, making the export available the next morning. No action is required of any OmniComm employee.
- Who retains ownership of the data?
The customer has all rights to the data, including ownership.
- What kind of ad hoc reports are available? Can these reports to be generated spontaneously by Sponsor staff or is your staff required to provide some service or intervention; and if so, what kind?
The Sponsor, or any role that is defined in the Administrative function of TrialMaster, can have access to run the Ad Hoc reporting tool anytime.
After training is provided by an OmniComm Trainer, an end user is able to query any data variable or group of data contained in the TrialMaster database. This includes data from iCRFs and data imported into TrialMaster. Most clinicians can create and save custom reports, including charts, graphs and calculations.
- Can protocol violations and deviations be tracked in the system?
Yes, they are referred to as Bypass Validations in the system. These violations are easily identifiable and there is a standard report to provide you with a listing.
- Is it possible to code Adverse Events and Concomitant Medications within TrialMaster?
Yes. Dictionaries such as MedDRA and WhoDrug are identified by the sponsor and can be integrated in the system. The level of coding, the dictionary version and who will have access to the coding, is defined by the sponsor.
- Can queries be generated within the system?
The roles to generate and respond to queries as well as update the data are defined by the sponsor. The ability to manage the query process through the workflow expedites the workload allowing the user to identify their tasks instantaneously and act on them to reconcile discrepancies and monitoring through database lock. The use of visual identifiers along with reports allows the users to easily identify queries and reconcile issues.
- Describe how data is locked.
Based on the specifications of the client, data can be locked at the form, visit, patient, site or trial level.
- Are standard reports available with the system?
Yes. Quite a number of reports are available to allow you to identify information such as project status, Adverse Events, SAEs, Concomitant Medications, Query/Note/and Bypass Validation reports etc. The reports allow you to resort, format and export them to Excel or MS Word. Custom reports are available on request.
Clinical Trial Management:
- What CTMS functionality is available with TrialMaster?
TrialMaster Core includes Trial Management features as listed below:
- Monitor Performance
- PI Performance
- Patient Management
- Work flow Management
- Inventory Management
- Regulatory/Safety Management
- Document Library
- Performance Reporting
- Built-in Randomization
- Alerts and email system
Support/Services:
- Does OmniComm provide for customer support?
In the US live help desk support is available 8:30 to 5:30 on normal business days, with 15 minute response time at all other times (24X7x365). In Europe, live help desk is available 8:30 to 5:30 Central European time, with 15 minute response time at all other times (24X7x365).
- How is training conducted?
OmniComm provides each study with a companion training website. The training site is a duplicate of the production site, including a training database. We provide on-site or remote training sessions, covering administrative training, site-specific training, investigator training and monitor-level training. On site/investigator meeting or train-the-trainer is available on request.
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