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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 6 subspecialists corresponding to the respective focus areas of research: pulmonology, cardiology, OB/GYN and rheumatology.

Rob Garver, MD

Pulmonary

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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.

Mike Wells

OB/Gyn

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Mike Wells received his MD from UAB, followed by a Family Practice Residency. He worked as a Family Practitioner for several years in the Navy and private practice, after which he completed a full OB/GYN residency at the University of South Alabama, becoming a diplomate of the American Board of Obstetrics and Gynecology. Mike founded Covington Obstetrics and Gynecology, which is now the only OB/GYN practice in Covington County. Ten years after starting the OB/GYN practice, he joined UAB as a clinical professor teaching OB/GYN at the residency level, but returned shortly thereafter to Covington OB/GYN. In addition to maintaining a large and busy practice, he has served as a member of the advisory council for the American Board of Obstetrics and Gynecology, Alabama Chapter, and is past president of the Covington County Medical Society. Since 2017, Mike has been active at SEC Clinical Research, serving as PI of clinical protocols focusing on endometriosis, uterine fibroids and hot flashes.

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

Andalusia

Andalusia is a small town with a population 70% White, 26% Black which has facilitated recruitment diversity. Rob Garver serves as PI for respiratory studies, and has his outpatient pulmonary clinic attached to the research facility. He is the only pulmonologist within a 75 mile radius. Mike Wells, our OB/GYN PI, is the founding partner of the only OB/GYN practice in the county.

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

Dothan is considerably larger than Andalusia with two hospitals, and serves as a tertiary referral area for the surrounding rural counties of lower Alabama and a significant swath of the Florida panhandle. The greater Dothan population is 62% White, 34% Black.

 

Ed Lacour is the rheumatology PI, Guy Middleton the women’s health PI, Andreas Muench the cardiology PI, and Marvin Sexton the respiratory PI. All of our PIs are highly respected clinicians with large practices that facilitate recruitment.

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

Respiratory:

Phase 2 – 4,
COPD/Asthma/IPF

Cardiovascular:

Phase 3, Heart Failure/

dyslipidemias

Women’s Health:

Phase 3, Endometriosis/
Fibroids/Hot Flash

Rheumatology:

RA
registry

Studies Enrolling and Ongoing (last updated January 2020)

 

Respiratory

1. A multicentre, double-blind, randomized, placebo controlled, parallel group, Phase 3, safety extension study to evaluate the safety and tolerability of Tezepelumab in adults and adolescents with severe uncontrolled asthma.

2. “A randomized, double blind, multicenter, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, and inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks.”

3. “A randomized, placebo-controlled, double-blind phase 3 clinical study to investigate the long-term safety of fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause”.

4.” 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 (COPD) COURSE)”.

5. “A multi-center, randomized, double-blind, parallel-group, placebo-controlled study of mepolizumab 100 mg SC as add-on treatment in participants with COPD experiencing frequent exacerbations and characterized by eosinophil levels”.

6. “A randomized, double-blind, placebo-controlled, multi-center, parallel group study to compare the efficacy of inhaled tiotropium + olodaterol, fixed dose combination (5ug/5ug) vs. placebo delivered by Respimat inhaler in patients with moderate to severe COPD, stratified by peak inspiratory flow rate [TRONARTO]”

 

Cardiovascular

1.”A multicenter, randomized, double-blind, active-controlled study to evaluate the effects of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction.”

2. “Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease”

3. “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”

 

Women’s Health

1.“An international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate Relugolix co-administered with and without low-dose estradiol and norethindrone acetate in women with endometriosis-associated pain.”

2. “A phase 3, randomized, placebo-controlled, 12 week double-blind study, followed by a non-controlled extension treatment period, to assess the efficacy and safety of fezolinetant in women suffering from moderate to severe vasomotor symptoms (hot flashes) associated with menopause”

3. “A randomized, placebo-controlled, double-blind phase 3 clinical study to investigate the long-term safety of fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause”.

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.

Contacts

Please direct general inquiries to: 

Lindsey Gomillion: l.gomi@secclinicalresearch.com.

 

Please direct questions about new studies or site capabilities

to our Site Director:

Rob Garver, MD: rg@secclinicalresearch.com