Patient Search

Recent reports indicate that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct by (a) increasing researchers’ administrative burden; (b) increasing overall trial conduct costs; (c) delaying initial project approval; (d) hampering medical record and registry research, and most critical; (e) impeding clinical trial recruiting and retention,¹ which in turn has deterred locating patients lost-to-follow-up (LTFU).

Subsequent to our recent post that focused on these factors that hinder the conduct of clinical trials as a consequence of the HIPAA, this commentary will serve as the first of several that will discuss strategies to enhance recruitment, retention, and finding patients LTFU based on

Clinical Trial Conduct

Assuring full compliance of guidelines mandated by governing authorities is critical to conducting successful clinical trial research and to subsequent product approval.  The federal government’s medical privacy rule, the Health Insurance Portability and Accountability Act (HIPAA), that went into effect in 2003 is such a mandate.  It has greatly impacted the conduct of clinical trials, however, not in a favorable way.  The focus of this post is to highlight various factors that have hindered the conduct of clinical trials as a consequence of rules imposed by HIPAA.

HIPAA of 1996 included a major provision that required

Efficiency of Clinical Trials

Conducting clinical trials is becoming increasingly arduous for drug manufactures due to several factors including: (a) heightened food and drug (FDA) regulatory scrutiny based on recent safety concerns; (b) inefficiencies and/or unclear guidance imposed by Health Insurance Portability and Accountability Act (HIPAA) guidelines in the research, design, enrollment and follow-up processes; (c) and increased demand and competition for patients due to a plethora of investigational products under study, as well as the increased scope and design of studies.¹ 

An obvious critical determinant of successful clinical trial research and subsequent product approval is to assure full compliance of regulatory/guidelines mandates of governing authorities throughout the entire clinical process. Other key determinants associated with the success and efficiency of clinical trials are recruitment, retention² and return, especially when

Patient Locate

We’d like to provide you additional information about OmniTrace Corp. and our patient locate services. 

Who Are We?

OmniTrace Corporation, a licensed and bonded private investigation agency, headquartered in Boca Raton, Florida, established in 2001, is the premier patient locate service provider to the clinical trial industry.

In the USA, Europe, South America and elsewhere, OmniTrace locates Lost To Follow-Up patients required to