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SEC Clinical Research began in early 2014 focused entirely on respiratory studies and has now diversified to include cardiovascular, women’s health and rheumatology as primary target areas. The trials are conducted in offices built specifically for research studies with experienced staff to support our PIs. Both of our sites have overnight capacity we have used for Phase 2 studies requiring 24-36 hr visits, and we have dedicated equipped laboratory space at both sites.

Our Principal Investigator team is comprised of subspecialists corresponding to the respective focus areas of research: pulmonology, cardiology, OB/GYN and rheumatology.

Rob Garver, MD

Respiratory

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Rob Garver received his MD and internal medicine training at Johns Hopkins, followed by a pulmonary fellowship at NHLBI.  He served as a faculty member in the UAB Pulmonary Division, ending his tenure there as Professor of Medicine.  He received critical care medicine board certification while at UAB which rekindled his clinical interests, including the pulmonary needs of underserved populations, which led to the formation of SEC Lung in Andalusia, AL.  Clinical research started as a small sideline to the practice in early 2013, and with rapid growth resulted in the formation of SEC Clinical Research in 2014.  Rob’s clinical practice has been curtailed in order to provide more time for research, and he has served as PI or SubI on more than 50 protocols since 2013.  His primary investigative interest are those studies pertaining to respiratory disease, but he has also been active in the cardiovascular space.  He is the site director for SEC Clinical Research.

Ed Lacour, MD

Rheumatology

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Ed Lacour received his MD from Tulane, and completed his rheumatology fellowship at Northwestern. He holds board certification for both Internal Medicine and Rheumatology. He began his career in academic medicine, serving on the clinical faculty at Northwestern, followed by a faculty position at the University of Arkansas. He left academic medicine, and is now the only rheumatologist in a large multi-specialty practice in Dothan, AL. Ed has a thriving practice that includes a large population of rheumatoid arthritis and psoriatic arthritis patients. He is an expert in osteoporosis and gout, and has served on advisory boards for several large pharmaceutical companies, including Merck and Janssen.

Guy Middleton, MD

OB/Gyn

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Guy Middleton received his MD from UAB, and completed his OB/GYN training at Baylor.  He has been a partner at Dothan OB/GYN, a leading OB/GYN group in Dothan where he has an active obstetrics practice mixed with gynecology.  Guy has been active in the medical community of Dothan, serving as Medical Director of the Women’s Center, Chairman of OB/GYN at Southeast Health Hospital.  He plays a leading role in multiple quality improvement initiatives for Women’s Health in Alabama, such as:  leadership team of the Alabama Perinatal Excellence Collaborative, member of the Collaborative Improvement and Innovation Network (COIIN) and as the inaugural member of the Alabama Maternal Mortality Review Committee.

Andreas Meunch, MD

Cardiology

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Andreas Muench received his MD from Otto-von Guericke University in Germany, followed by internal medicine residency at University of Kansas Medical Center.  Residency was followed by fellowships in Cardiovascular Disease and Interventional Cardiology at University of Texas – Houston, and he is now boarded in both Cardiovascular Disease and Interventional Cardiology.  Andreas has a busy practice with a mix of both general and interventional cardiology cases, and more recently has been performing TAVR in addition to more traditional interventions.  Based in Dothan, he  also holds satellite clinics in western Georgia and the Florida panhandle.  He has worked closely with SEC Clinical Research since 2017 as both SubInvestigator and Principal Investigator, providing a large population for recruitment into heart failure and dyslipidemia protocols.

Marvin Sexton, MD

Respiratory

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Marvin Sexton received his MD from UAB, and completed his internal medicine (including Chief Medical Resident(, pulmonary, critical care and sleep medicine – and is now ABIM certified in Internal Medicine, Pulmonary Medicine, Critical Care Medicine, and Sleep Medicine. Marvin has spent his career at Dothan Pulmonary Associates, the only pulmonary medicine practice in Dothan serving both hospitals. He has been held multiple leadership positions in the Dothan medical community, having served in the recent past as Chief of Medicine, Medical Director of Critical Care Medicine and Medical Director of Sleep at Southeast Health Hospital. He also teaches at the Alabama College of Osteopathic Medicine. His practice is enormous, and facilitates recruitment into challenging respiratory protocols. Since 2017, Marvin has been active in clinical research, serving as both PI and SubI on COPD, asthma and IPF studies performed at SEC Clinical Research.

The investigative team is strongly supported by an experienced support team including on-site licensed practitioners trained in both oversight and all visit procedures, CRCs, RAs, and a Recruitment Team.

Kelly Hammet, CRNP

SubInvestigator/CRC

Ashley Thomas

SubInvestigator

Bobby Chambers, RN BSN

CRC

Anna Ware, RN

CRC

Paula McMiller, MA

RA

Natasha Smith

RA

Michelle Garver, RN- BSN

Recruitment Specialist

Lindsey Gomillion, RN BSN

Recruitment Specialist

Tori Anderson

Administrative Support

Victoria Worley

Business Manager

SEC Clinical Research infrastructure attributes at all locations:

  • All computers and networks upgraded, security enhanced 2021
  • CTMS
  • Electronic Regulatory Documents
  • Electronic Source Documents
  • Document Management System

Dothan

Dothan is located in the southeast corner of Alabama, with a greater metro population just under 150,000 that is comprised of 34% African-American and 62% Caucasian. Two large hospitals in Dothan provide tertiary care for the large medical catchment area which includes surrounding counties in AL, and a significant swath of the Florida panhandle. The medical community is large, busy, and includes all major medical and surgical subspecialties.

Dothan 1: This facility was custom designed and built for clinical research, replacing the original Dothan research site in 2019.

 

Key Facility Attributes:

  • Custom built for clinical research
  • Dedicated IP room – fully temperature monitored and alarmed
  • Locked chart room
  • Extended stay/overnight rooms
  • Shower
  • Dedicated lab
  • Generous workspace for staff and monitors

 

Dothan 2: This facility was also custom designed and built for clinical research, opening in August 2021.  This office is located located a little over 1 mile from Dothan 1, providing additional space for staff and research studies.

 

Key Facility Attributes:

  • Dedicated IP room – fully temperature monitored and alarmed
  • Locked chart room
  • Oversized lab to accommodate substudies and PBMC isolation
  • Generous workspace for staff and monitors
  • Close to Flowers hospital, adjacent to private medical imaging facility

Pensacola

We are excited to be opening first facility in Pensacola in a freestanding former medical office building directly across the street from Baptist Hospital, conveniently located with on-site parking.

 

Key Facility Attributes:

  • Dedicated IP room – fully temperature monitored and alarmed
  • Locked chart room
  • Generous workspace for staff and monitors
  • Directly across street for the Baptist Hospital ER

Andalusia

Andalusia is the birthplace of SEC Clinical Research, and now serves as the headquarters for administrative functions including finance, recruitment and regulatory.

Respiratory:

Phase 2 – 4,
COPD/Asthma/IPF

Cardiovascular:

Phase 3, Heart Failure/

dyslipidemias

Women’s Health:

Phase 3, Endometriosis/
Fibroids/Hot Flash/Maternal Vaccines

Rheumatology:

RA
registry
Psoriatic Arthritis

Studies Enrolling and Ongoing (last updated December 2021)

 

Respiratory

1. A randomized, Double-Blind, Placebo-Controlled, parallel group, multicenter, Phase 2A study to explore efficacy and safety of Tezepelumab in patients with moderate to very severe chronic obstructive pulmonary disease. (COURSE)

2. A 52-week, randomized, double-blind, double-dummy, placebo-and active controlled (Roflumilast, Daliresp™ 500ug), parallel group, study to evaluate the efficacy and safety of two doses of CHF6001 DPl add-on to maintenance triple therapy in subjects with Chronic Obstructive Pulmonary disease (COPD)and chronic bronchitis. (PILLAR)

3. a phase lll, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of astegolumab in patients with Chronic Obstructive Pulmonary Disease.

4. A 12-week, randomized, participant and investigator blinded, placebo controlled, parallel group study to explore the efficacy, pharmacodynamics, safety, and pharmacokinetics of two doses of inhaled CSJ117 in adults with Chronic Obstructive Pulmonary Disease.

5. A Phase lll, multicenter, randomized, double-blind, chronic-dosing, parallel-group, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of MEDl3506 in participants with symptomatic chronic obstructive pulmonary disease (COPD)with a history of COPD exacerbations (TITANIA)

 

Cardiovascular

1. A randomized Double-Blind, Placebo-Controlled, multicenter trial assessing the impact of Lipoprotein(A) lowering with TQJ230 on major cardiovascular events in patients with established cardiovascular disease. (HORIZON)

 

2. A Double-Blind, randomized, placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease. (ORION-4)

3. A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2)

 

Women’s Health

1.  A Phase 3, randomized, Double-Blind, Placebo-Controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RV maternal vaccine, administered IM to pregnant women 18-49 years of age, for prevention of RSV associated LRTI in their infants up to 6 months of age. (GRACE)

2. A Phase lll, double-blind, randomized, placebo-controlled study to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of unadjuvanted RSV Maternal Vaccine, in high-risk pregnant women aged 15-49 years and infants born to the vaccinated mothers.

 

Vaccines

1. A Phase 3, randomized, Double-Blind, Placebo-Controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RV maternal vaccine, administered IM to pregnant women 18-49 years of age, for prevention of RSV associated LRTI in their infants up to 6 months of age. (GRACE)

2. A Phase lll, double-blind, randomized, placebo-controlled study to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of unadjuvanted RSV Maternal Vaccine, in high-risk pregnant women aged 15-49 years and infants born to the vaccinated mothers

 

Rheumatology

1. A Phase 3, randomized, Double-Blind, Placebo-Controlled study to demonstrate efficacy and safety of Tildrakizumab in anti-TNF experienced subjects with active psomatic arthritis I. (INSPIRE)

Administrative Information

Frequently asked Questions from Feasibility Questionnaires:

Do you have dedicated research staff for protocols?

Yes, we presently have a nurse practitioner at both sites serving a dual role as subinvestigators and CRCs, 2 additional full time CRCs, and 3 research assistants.

Do you have a dedicated space for storage of IP?

Yes, at each site we have a double locked room used only for IP storage.  These rooms have a heating and cooling system, and there is continuous temperature monitoring of IP stored at ambient, refrigerated and frozen temperatures with an alarm that sends a cell phone alert for temperature excursions.

Do you have an onsite lab for processing specimens?

Yes, both locations have refrigerated centrifuges for routine blood processing.  We also have equipment for sputum cytology processing.

Does your site utilize central or local IRBs?

We are delighted to use Central IRBs.  We only use a local IRB of one hospital if there is any inpatient component to a study.

What is your typical budget/CTA turnaround time?

Two weeks is typical.

Does your site require any additional approvals or reviews beyond IRB?

No

Will your site complete regulatory documents prior to IRB approval?

Yes.

Does your site use electronic regulatory documents and electronic source documents?

We are transitioning to electronic documents 4th quarter 2021. Electronic source documents will be starting 1st-2nd quarter 2022.

Contacts

Please direct general inquiries to: 

Cindy Henexson:  admin1@secclinicalresearch.com.

 

Please direct questions about new studies or site capabilities

to our Site Director:

Rob Garver, MD: rg@secclinicalresearch.com