OmniTrace Locates Patients Lost To Follow-Up

OmniTrace FAQs

  • Back to TopWhat primary function does OmniTrace provide to a clinical study?

    OmniTrace provides the administrative function of updating current contact information for subjects identified as LTFU or at risk of LTFU.  Our second primary area of involvement is assisting to obtain the vital status data of designated subjects. These two key functions are required to maintain study integrity by significantly reducing missing data.

  • Back to TopDoes OmniTrace provide additional clinical trial support services?

    OmniTrace provides comprehensive project support including ICF language review, LTM/CRA/Site LTFU training, IRB and EC response and rebuttals, death certificate retrieval, MAE monitoring, EDC assistance, Site communication, metrics development as well as other custom services.

  • Back to TopWhat is OmniTrace’s experience with clinical trials?

    OmniTrace has assisted clinical trials since 2003, worked on hundreds of domestic and global studies and has successfully handled over twenty thousand requests.  OmniTrace is one of the premier providers of LTFU services and is the primary option when a firm has an issue with Lost to Follow-Up patients (LTFU) or is simply establishing an LTFU contingency plan.

  • Back to TopWho are OmniTrace’s typical clients?

    OmniTrace’s clients consist of Pharmaceutical Companies, CROs, AROs, Hospitals, public research institutions and government agencies such as the National Institutes of Health.

  • Back to TopIs OmniTrace licensed and insured?

    OmniTrace is licensed (A2200304) by the State of Florida as a Private Investigative Agency. OmniTrace’s current coverages include General Liability and Errors and Omissions of $2,000,000.00 per Occurrence and $2,000,000.00 Aggregate.

  • Back to TopWhat countries does OmniTrace provide services to?

    OmniTrace’s LTFU search capabilities are global in scope.  We also work with our clients, ethics committees and IRBs to determine if any local regulations prevent the use of our service. OmniTrace offers multiple international programs to select from or can customize a program to suit EC requirements.

  • Back to TopHow long does an average search last?

    For USA searches average turnaround time is 24 – 48 hours.  Internationally, the length of time for a search will vary by the country and program selection. Turnaround time can typically range from 3 days to 6 weeks depending on the type of search we conduct.

  • Back to TopHow does OmniTrace collect information from Sites?

    OmniTrace prefers not to transmit subject data electronically as part of its standard operating procedures. Information is received and transmitted to Sites via facsimile. If faxing is not an option, we can verbally transmit information or utilize other secure means.

  • Back to TopDoes OmniTrace utilize independent contractors?

    In the USA, all searches are conducted by OmniTrace employees.  Globally, all searches are initially conducted by OmniTrace employees.  If the results of an international search are not successful, we can utilize the assistance of a local, in-country investigator but only when authorized by the client.

  • Back to TopCan OmniTrace assist us in scheduling a patient visit or collect medical data?

    OmniTrace is not involved with patient medical issues, data collection or patient interviews. We do not access medical records as part of our search.  We only are providing the administrative function of updating contact information or providing vital status.

  • Back to TopWhat information does OmniTrace need to conduct a search?

    We typically only require the patient’s name, last known address, previous phone number and date of birth.

  • Back to TopCan you tell us about OmniTrace’s compliance?

    OmniTrace maintains strict patient privacy guidelines and data security policies. HIPAA, HITECH, GCP, EU Data Directives, Graham-Leach Bliley and other associated regulations are embedded in our processes. OmniTrace’s records and processes are open for audit and assessment.

  • Back to TopHas OmniTrace been subject to any FDA Audits?

    OmniTrace has never been subject to an FDA or regulatory audit, but our facilities and policies have been assessed and audited on multiple occasions by numerous clients. 

  • Back to TopHow long does OmniTrace archive subject information?

    OmniTrace only maintains hard copy records for a period of two years. No electronic records are maintained.

  • Back to TopDoes OmniTrace communicate directly with IRBs and Ethics Committees?

    OmniTrace works with the Sponsor to respond to IRB/EC questions regarding our services but typically works at arm’s length versus directly.  OmniTrace will assist in answering any questions an IRB or EC may have, provide policy documents pertaining to our services, assist in preparing amendment letters and otherwise work with the sponsor, Site and EC/IRB to gain approval.

  • Back to TopWhy Use OmniTrace?
    • Significantly reduce the number of LTFU patients
    • To provide 100% vital status on all subjects
    • Monitor Major Adverse Events
    • Reduce FDA scrutiny
    • Maximize clinical trial success 
    • Eliminate missing trial data
    • Allow for a faster clinical trial endpoint
    • Enhance regulatory compliance and post study surveillance
    • Greatly reduce clinical trial cost
  • Back to TopCan you tell us more about OmniTrace’s vital status programs?

    Domestically, OmniTrace is often requested to conduct vital status determinations on large subject populations as various endpoint and study outcome dates approach. OmniTrace provides an “alive as of date” or “date of death” along with a supporting reference. These vital status runs can be scheduled in advance or on an as needed basis.  Internationally, there is a lack of searchable death records and therefore vital status determinations are often predicated on locating the subject alive.