RESEARCH SERVICES

One of the most important contributors to the high quality standards of L-MARC Research Center is the focus on training.  During offsite and onsite Investigator Meetings, the research staff undergoes training in study protocol conduct.  This is often reaffirmed during Site Initiation Visits with study sponsor representatives. 

General training includes review of the L-MARC Standard Operating Procedures and cardiopulmonary resuscitation (CPR) training. Additional instructions include general training in Good Clinical Practices (GCP), Interactive Voice Response Systems (IVRS), Interactive Web Response System (IWRS), Interactive Voice/Web Response Systems (IXRS), Electronic Data Capture (EDC), and various study portal access and use.  Study-specific training may also include training regarding unusual procedures and other tasks unique to that clinical trial.

In addition to training provided by the Study Sponsor and Contract Research Organization during the Investigator Meeting and Site visits, L-MARC Research Center has its own ongoing staff independent training. This L-MARC specific training includes biannual offsite meeting presentation and discussion of:

- Good Clinical Practice (GCP)
- FDA compliance and audit
- Occupational Safety and Health Administration (OSHA)

The L-MARC staff also undergoes annual testing and discussion of:

- Good clinical practice
- Informed consent process
- Standard Operating Procedure
- FDA audit preparation
- OSHA

After completion of internal training, elegible employees receive an L-MARC Training Certificate.

INVESTIGATOR OVERSIGHT OF RESEARCH ACTIVITIES

As Medical Director, Dr. Harold Bays is the Principal Investigator for the vast majority of clinical trials conducted at L-MARC Research Center. He engages in active oversite on multiple levels, including:

• Study participant level
• Study level
• Site level
• Scientific level

Study participant level

We feel clinical research quality is best achieved by utilizing a team approach.  Our  research coordinators and subinvestigators usually conduct the informed consent process.  Nurse Practitioners usually conduct the physical exams.  Dr. Harold Bays is available to answer questions, and help manage medical challenges that periodically occur during the course of clinical trials.

Dr. Harold Bays' office is in the L-MARC Research Center building where the research activities occur.  Dr. Bays is in the office most every day (including weekends and holidays), and thus available for study-related activities.  On travel days, Dr. Bays is available by smartphone, email, or text messaging.  Subinvestigators are available to cover during times Dr. Bays is not immediately available.

Dr. Bays' oversight includes:

- Available to meet and speak with study monitors and other study personnel
- Reviewing study-related issues and materials (“signings”)
- Answering questions from study participants and research staff
- Crafting, reviewing, and signing interim letters regarding health issues that arise in study participants
- Recommending management plans to both the study participant and treating clinician when appropriate

Dr. Bays reviews and signs:

• Study-related regulatory documents
• Concomitant medications
• Physical exam documents
• Study laboratory (e.g., blood and urine tests)
• Electrocardiograms
• Diagnostic tests (e.g., DXA scans, FibroScans etc.)
• Adverse experience reporting
• Causality of adverse experiences
• Protocol deviations
• Study safety reports
• “Entry letters” to the treating clinician and study participants
• “Exit letters” to the treating clinician and study participants

Study level

Dr. Harold Bays is active in many aspects of study development, such as serving as the overall Principal Investigator of clinical trials, protocol development, presentation of study results, publication of study results, patent claims, and regulatory presentations to the Food and Drug Administration, as it pertains to drug indication approvals.

Site level

As Medical Director, Dr. Harold Bays is personally, and actively involved, and oversees basic operations of L-MARC Research Center.   Some of these activities include:

- Interviews and selects the highest quality research staff
- Designed the building specifically for research
- Engaged in research facility infrastructure upkeep (see the "Facilities & Equipment" tab to the left)
- Authored and continues to revise the L-MARC Research Center Standard Operating Procedures
- Oversees staff training (see "Training" tab to the left)
- Conducts weekly study team meetings
- Conducts biannual offsite training meetings

Scientific level

Dr. Harold Bays is highly active in advancement of medical science.
- Maintains certification in Endocrinology, Obesity Medicine, Obesity Medicine, Clinical Lipidology, and Internal Medicine
- Has served as an Investigator for over 500 clinical trials
- Has authored and published over 200 peer reviewed journal articles
- Has authored and presented hundreds of abstracts at scientific meetings
- Has served as first author for a number of Scientific Recommendations, Algorithms, and Scientific Statements
- Is an active member of several scientific organizations
- Is a Fellow of several scientific organizations
- Has served as an Officer for a number of scientific organizations