Categories
Case Studies Lost-To-Follow-Up

Case Study #2

A medium sized pharmaceutical firm conducted a 56 week phase III trial to access the safety and efficiency of an obesity treatment program.

Goal: Retrieve patient contact information from each site, locate the current contact information and return it to the site. If a patient was deceased we were to provide their date of death and the resource of such data. Additionally, we were to attempt to obtain a death certificate for each subject. If the subject was alive, we were to provide the most recent “alive as of” date.

Total Subjects: 416
Number of sites: 87

Result: OmniTrace successfully determined the vital status for 99% of the subjects provided.

Categories
Case Studies Lost-To-Follow-Up

Case Study #1

A large pharmaceutical company conducted a randomized, open label, blinded-endpoint parallel group study to investigate if a particular drug has a lower incident of GI Events than other similar drugs in subjects with osteoarthritis.

Goal: Retrieve patient contact information from each site, locate the current contact information and return information to the site.

Total LTFU Subjects: 443
Number of Sites: 208

Result: OmniTrace was successful in locating 91% of all LTFU patients.

Categories
FAQs Lost-To-Follow-Up

Are OmniTrace searches compliant?

OmniTrace conducts legal and permissible research of publicly available records and databases where local regulations allow and when appropriate patient consent has been obtained.

Categories
FAQs Lost-To-Follow-Up

How long does an average search last?

For USA searches average turnaround time is 24 – 48 hours.  Global searches will vary by country and may range from 7-21 days. 

Categories
FAQs Lost-To-Follow-Up

Who are OmniTrace’s typical clients?

OmniTrace’s clients consist of Pharmaceutical Companies, CROs, AROs, Hospitals, clinical trial sites and government agencies such as the National Institutes of Health.

Categories
FAQs Lost-To-Follow-Up

What is OmniTrace’s experience with clinical trials?

OmniTrace supported our first study in 2003, and since have successfully handled over twenty-five thousand Lost to Follow-Up related requests globally.  OmniTrace is the world’s premier providers of LTFU services.” To “OmniTrace supported our first study in 2003, and since have successfully handled over twenty-five thousand Lost to Follow-Up related requests globally.  OmniTrace is the world’s premier provider of LTFU services.

Categories
FAQs Lost-To-Follow-Up

What additional clinical trial support does OmniTrace provide?

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.

Categories
FAQs Lost-To-Follow-Up

Are your services available globally?

OmniTrace’s services are available in over fifty countries.

Categories
FAQs Lost-To-Follow-Up

How does OmniTrace support a clinical trial or study?

OmniTrace conducts research of publicly available records and databases to identify current contact information or vital status data on subjects who are Lost to Follow-Up or have withdrawn consent.  This simple, crucial function significantly reduces missing data that may bias in study results and hinder the regulatory process.  

Categories
FAQs Lost Heir Search

Is OmniTrace Insured?

OmniTrace has $2,000,000 in Professional Liability Insurance against Errors and Omissions. We are proud to state that we have never had a claim.