Research Capability
FCN Medical Group is a multi-center medical and clinical research center with several satellite locations in the Atlanta and Philadelphia areas. We have access to a diverse patient population of over 100,000 individuals, primarily from minority groups, through our physician practices and patients at Crozer-Chester Medical Center. We are equipped to conduct research across a diverse array of therapeutic areas. Our dedicated team comprises a Clinical Director, a Medical Safety Officer, and numerous Primary Investigators, all of whom are CITI trained and specialize in various therapeutic fields. With over 75 years of combined experience in Phase 1 to Phase 4 clinical trials, we are committed to delivering high-quality research outcomes.
Project Management and Clinical Monitoring
FCN Medical Group stands out as a leader in healthcare solutions by integrating extensive project management expertise with a team of highly experienced clinical monitors. Our dedicated clinical monitoring team boasts a minimum of five years of clinical monitoring experience each, ensuring that they possess the knowledge and skills necessary to uphold the highest standards in patient safety and compliance. This depth of experience allows us to effectively oversee various clinical trials and research projects, ensuring that all regulatory requirements are met and that patient care remains a top priority.
In addition to our clinical monitoring capabilities, our project management team brings over 20 years of experience in the field. This wealth of knowledge enables us to implement proven methodologies that ensure our projects are completed efficiently, on time, and within budget. We prioritize collaboration and continuous improvement, empowering healthcare teams to reach their objectives while enhancing overall patient outcomes.
Moreover, we maintain a rigorous focus on professional development, with all physicians and research personnel certified through CITI training. This commitment to training ensures that our teams are equipped with the latest knowledge and best practices in clinical research, further solidifying our position as a trusted partner in the healthcare industry. With our comprehensive approach, FCN Medical Group is dedicated to delivering high-quality healthcare solutions that meet the evolving needs of patients and providers alike.
Facilities and Infrastructure
FCN Medical Group boasts comprehensive facilities and infrastructure to support both clinical research and patient care. We have access to a diverse patient population of over 100,000 individuals, primarily from minority groups, through our physician practices and patients at Crozer-Chester Medical Center. This extensive network enhances our research capabilities and participant diversity. Our facilities include:
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100,000+ potential subjects
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Central IRB Capable
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Multiple exam rooms
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Access to medical center resources including emergency services, X-ray, CT scans, MRI, PET, and mammography
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Two conference rooms
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Dedicated space for clinical monitors
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Clinical storage for binders, lab kits, and documents
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Dedicated refrigerator for investigational product storage (2-8 °C) and (-70 °C) with temperature monitoring
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Drug storage cupboard with temperature and humidity controls
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Secured storage for investigational products
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Fax machine
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Standard phone line
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High-speed internet
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Therapeutic Experience:
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Heart Disease
Adult Congenital Heart Disease Heart Failure -
Diabetes
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Thyroid Disease
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Adrenal Insufficiency
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Inflammatory Bowel Disease
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Colitis
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Liver Disease
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Chronic Kidney Disease
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Kidney Stones
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Acute Kidney Failure
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Asthma
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COPD
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Depression
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Anxiety
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Addiction
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Mood Disorders
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Arthritis
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& More
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Compliance, Audits, and Quality Assurance/Control (QA/QI)
FCN Medical Group is committed to maintaining the highest standards of quality and compliance in clinical research. We strictly adhere to the guidelines established by the International Conference on Harmonization Good Clinical Practice (ICH GCP) and relevant U.S. Food and Drug Administration (FDA) regulations as outlined in Title 21 of the Code of Federal Regulations (CFR). Our operations are governed by a comprehensive framework of Standard Operating Procedures (SOPs) that align with both GCP and FDA standards, ensuring that all personnel receive thorough training on these critical guidelines.
We prioritize ethical conduct, safeguarding the rights, safety, and well-being of our study participants. Informed consent is carefully obtained and documented in line with ICH GCP E6(R2). Our research designs are rigorously developed to ensure scientific validity, yielding robust and reproducible results. We maintain a Quality Management System (QMS) that systematically monitors our research activities, ensuring compliance with GCP guidelines.
In addition to adhering to ICH GCP principles, we comply with important sections of Title 21 CFR, including regulations regarding the protection of human subjects (CFR Part 50), the role of Institutional Review Boards (CFR Part 56), Investigational New Drug Applications (CFR Part 312), and Investigational Device Exemptions (CFR Part 812). Our commitment to these regulations underscores our ethical and scientific integrity in conducting clinical trials involving investigational products.
To achieve high-quality research outcomes, our operational procedures stress rigorous adherence to protocols while allowing flexibility to meet individual participant needs without compromising data integrity. All clinical and support staff undergo comprehensive training in relevant regulations and SOPs before engaging in any study, with ongoing education to ensure they remain informed of the latest developments in the field. We uphold strict data integrity and security measures, ensuring that all collected data is accurate, complete, and securely stored to protect participant confidentiality.
We implement continuous monitoring practices, including internal audits and quality assessments, to identify areas for improvement and ensure compliance with all regulatory requirements. At FCN Medical Group, we recognize the importance of conducting quality research with integrity and transparency, demonstrating profound respect for our participants. Our commitment to complying with ICH GCP guidelines and FDA regulations reflects our dedication to achieving high-quality research outcomes that contribute to advancements in medical knowledge and patient care.
Recruitment and Retention Plan
The success of FCN Medical Group hinges on the effectiveness of its Recruitment and Retention Plan for clinical studies. FCN Medical Group implements a comprehensive Subject Recruitment and Retention Plan that significantly contributes to its success in recruiting and retaining subjects for clinical trials. By leveraging access to a diverse patient population, the group engages with over 100,000 potential research subjects. This patient pool consists of approximately 80% African American, 15% Latino or Hispanic, 4% White, and 1% Asian individuals, all associated with Crozer-Chester Medical Center and FCN Medical Group’s affiliated practices. The overall strategy focuses on optimizing participation and retention through targeted outreach initiatives and robust support services.
The primary objectives of FCN Medical Group’s recruitment plan are to harness its extensive and diverse patient population for timely enrollment, enhance demographic representation in clinical trials—particularly for underrepresented communities—and maintain high retention rates that exceed industry standards. By achieving these goals, the organization creates a more inclusive and effective research environment.
Recruitment efforts center around patients who meet the eligibility criteria of specific clinical trials, with a clear focus on representing the demographics of the local population. This approach is crucial for addressing health disparities and ensuring that the research conducted reflects the needs and conditions of a broad audience.
To execute the recruitment strategy, FCN Medical Group utilizes electronic health records (EHR) to identify potential candidates who fit the trial inclusion criteria. Engagement with physicians plays a vital role in this process, and the organization provides regular training workshops to educate clinic staff about available trials, encouraging them to refer eligible patients. Additionally, the organization holds monthly research meetings to discuss enrollment targets and strategize ways to reach diverse populations. Community outreach also forms a significant component of the recruitment strategy. Collaborations with local organizations focused on African American and Latino communities allow for effective awareness-raising about clinical trials. Participation in health fairs and community events further engages potential participants directly.
Targeted communication efforts include personalized outreach through phone calls and mailers aimed at patients identified as potentially eligible based on their medical history. The group develops culturally sensitive recruitment materials, including translations in Spanish, to better connect with diverse populations. Digital campaigns, particularly through social media, educate the community about the significance of clinical trials, highlighting how participation can contribute to medical advancements.
The enrollment process is designed to be efficient and participant-friendly. Dedicated research coordinators conduct initial screenings, ensuring a streamlined approach for interested individuals. Follow-up appointments are scheduled for comprehensive eligibility assessments, with the informed consent process made accessible, including materials available in multiple languages. Clear explanations of trial procedures and expectations help alleviate any concerns participants may have during enrollment.
Retention strategies are equally important in maintaining participant engagement. FCN Medical Group establishes a dedicated patient support team responsible for regular communication with participants. This team ensures participants receive routine check-in calls to answer questions and address concerns, and they coordinate transportation services to facilitate access to appointments. Engagement efforts include informational sessions and ongoing education about the trials, fostering a sense of community and enhancing understanding of the research process. Regular updates through newsletters keep participants informed of study milestones.
Monitoring and evaluation of the recruitment and retention strategies are conducted rigorously. A data management system tracks recruitment metrics, focusing on demographics, enrollment rates, and dropout statistics. Regular bi-weekly review meetings allow the team to assess recruitment progress, navigate challenges, and make necessary adjustments to strategies. Upon completion of trials, a thorough analysis of recruitment and retention outcomes is conducted to identify best practices and areas for improvement in future studies.
In conclusion, FCN Medical Group’s comprehensive recruitment and enrollment plan robustly enhances its capacity to maximize participation in clinical trials. By ensuring diverse representation and focusing on patient experience through effective outreach and support, the organization achieves its enrollment goals and maintains high retention rates. These efforts ultimately contribute to impactful clinical research outcomes, showcasing FCN Medical Group's commitment to advancing medical knowledge through inclusivity and community engagement.
Support for Independent Research: Protocol Writing, Development, and Grant Proposals
FCN Medical Group offers invaluable support to independent researchers and postgraduates in the challenging tasks of writing research protocols and grant proposals, particularly aimed at funding their initiatives. Recognizing that many new researchers find proposal writing daunting, FCN Medical Group provides comprehensive guidelines and critical steps to develop standard research protocols that enhance the likelihood of successful grant applications.
A well-structured protocol is vital for the success of any clinical research project. It outlines the research plan, establishes eligibility criteria for participants, details the study's duration, and specifies the medications and tests involved. The protocol is directed by a chief researcher and ensures safety and effectiveness through regular health checks conducted by the research team. Notably, FCN Medical Group also offers independent monitoring throughout the research study process, ensuring that safety and data efficacy are maintained from study inception through to completion.
Key components of a high-quality research proposal include a clear hypothesis, justification for the study's significance, a detailed methodology, and a comprehensive research design. Additionally, the proposal should present a proposed timetable and budget and include an assessment of required resources—whether technical, scientific, or financial. By meticulously drafting their protocols, researchers can enhance the scientific rigor of their conclusions and improve their chances of securing funding.
FCN Medical Group encourages researchers to seek feedback from colleagues and experts during the planning phase, emphasizing the importance of maintaining protocol integrity throughout the study. If challenges arise during the research, the organization recommends conducting pilot studies to assess feasibility rather than altering the existing protocol, ensuring that the project remains focused and relevant.
In summary, FCN Medical Group is dedicated to empowering researchers by providing robust support in both protocol writing and grant proposal development, along with independent monitoring for safety and data integrity. This comprehensive assistance is crucial for facilitating successful scientific endeavors and securing the funding necessary to advance their research initiatives.
(Updated January 31, 2025) Research Capability Statement.pdf
Clinical Trial Experience
A Long-Term Intervention With Pravastatin In Ischaemic Disease (LIPID) Study Group With Glyburide In African American And Hispanic Patients With Type 2 Diabetes Not Controlled By Glyburide Alone
A Randomized Controlled Trial Aliskiren And The Calcium Channel Blocker Amlodipine Combination As An Initial Treatment Strategy For Hypertension Control (ACCELERATE): A Randomised, Parallel-Group Trial Vardenafil (Levitra) For Erectile Dysfunction: A Systematic Review And Meta-Analysis Of Clinical Trial Reports
A Randomised Controlled Trial Assessing The Efficacy And Safety Of Repeated Tegaserod Therapy In Women With Irritable Bowel Syndrome With Constipation Efficacy And Safety Of Combined Use Of Aliskiren And Valsartan In Patients With Hypertension: A Randomised, Double-Blind Trial
A Randomized Controlled Trial (RCT) Conducted By Amgen To Evaluate The Impact Of Anemia Therapy On Cardiovascular Events In Patients With Chronic Kidney Disease (CKD) And Type 2 Diabetes
A Randomized Clinical Trial Of The Safety And Efficacy Of Sitagliptin And Metformin Co‐Administered To Chinese Patients With Type 2 Diabetes Mellitus
A Combination Formoterol And Budesonide As Maintenance And Reliever Therapy Versus Current Best Practice (Including Inhaled Steroid Maintenance), For Chronic Asthma In Adults And Children
A 24-Hour Ambulatory Blood Pressure Control With Triple-Therapy Amlodipine, Valsartan And Hydrochlorothiazide In Patients With Moderate To Severe Hypertension
A Randomized Controlled Trial Of A New-Generation Ultra-Long-Acting Insulin Compared With Insulin Glargine
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 To 52 Week Variable Length Study To Assess The Efficacy And Safety Of Budesonide, Glycopyronium, And Formoterol Fumarate Metered Dose Inhaler (MDI) Relative To Budesonide And Formoterol Fumarate MDI And Symbicort® Pressurized MDI In Adult And Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Assess The Safety, Efficacy And Pharmacodynamics Of TEV-53275 Administered Subcutaneously In Adult Patients With Persistent Eosinophilic Asthma (TV53275-AS-20033)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Assess The Efficacy, Safety, And Tolerability Of Dexpramipexole Administered Orally For 52 Weeks In Participants With Severe Eosinophilic Asthma (EXHALE-3)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Assess The Efficacy, Safety, And Tolerability Of Dexpramipexole Administered Orally For 24 Weeks In Participants With Eosinophilic Asthma (EXHALE-4)
A Prospective Observational Study Designed To Assess The Performance Characteristics Of The CleoDX Ovarian Adnexal Mass Score Test System For Pre-Surgical Triage Of Patients Identified With An Adnexal Mass (CSP-01-001)
A Study Is To Demonstrate The Clinical Performance Of The Savanna STI Assay For The Detection And Differentiation Of DNA From Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG), Mycoplasma Genitalium (MG), And Trichomonas Vaginalis (TV)
A Collection Of Prospective And Retrospective Biological Samples And Associated Data For Research (SERATRIALS-05035)
A Prospective, Natural History Study To Assess The Occurrence Of HPA-1a Alloimmunization In Women Identified At Higher Risk For Fetal And Neonatal Alloimmune Thrombocytopenia (FNAIT) (IPA2002)
A 8-Week Randomized, Double-Blind, Parallel Group, Multicenter, Placebo And Active Control Dose Escalation Study To Evaluate The Efficacy And Safety Of The Efficacy And Safety Of Saxagliptin (BMS 477118) In Combination With Thiazolidinedione
A Multicenter, Randomized, Double-Blind, Active Controlled Phase III Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Combination With Metformin IR
A Multicenter, Double Blind Parallel Study To Evaluate The Tolerability Of MK-0524A Versus Niacin Extended Release
A 8-Week Multicenter, Randomized, Double-Blind, Parallel Group Study To Evaluate The Efficacy And Safety Of The Combination Of Valsartan/HCTZ, Valsartan/Amlodipine, And HCTZ/Amlodipine
A 12-Week Multicenter, Randomized, Double-Blind, Parallel Group Study To Evaluate The Efficacy And Safety Of Orally Administered Valsartan/Amlodipine
A Multicenter, Randomized, Double-Blind, Controlled Multicenter Study To Compare The Effect Of A 24-Week Treatment With A Fixed Combination Therapy Of Vildagliptin And Metformin
A Multicenter, Open Label Sub-Study To LMF237A2302 To Access The Effects Of 24 Weeks Treatment With Initial Combination Of Vildagliptin 100mg QD Plus Metformin 100mg
A Multicenter Randomized Double Blind Parallel Group, 12-Week Study To Evaluate The Efficacy And Safety Of MK-0524B (Dose As Co-Administered MK-A And Simvastatin Tablets) Versus Atorvastatin
A 16-Week Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study To Compare The Safety And Efficacy Of Starflix (Nateglinide) Vs Placebo
A Phase III, Double-Blind, Randomized Placebo Controlled Study To Evaluate The Efficacy The Efficacy And Safety Of TAK-491 In Subjects With Essential Hypertension.
A Double-Blind Multicenter, Randomized Placebo Controlled Study To Evaluate And Efficacy The Safety Of TAK-491.
A Multicenter, Randomized, Double Blind Placebo And Active Controlled, Parallel Group, Dose Range Study To Evaluate The Efficacy And Safety Of LCZ696.
A Multicenter, Randomized, Double-Blind Study To Evaluate The Safety And Efficacy Of The Initial Therapy With Co-Administration Of Sitagliptin And Pioglitazone
A Randomized, Double-Blind, Active Comparator Controlled Clinical Trial To Study The Efficacy And Safety Of MK-0431A For The Treatment Of Patients With Type II Diabetes Mellitus.
A Phase III Double-Blind Randomized Study To Determine The Efficacy And Safety Of Pioglitazone HCI And Metformin HCI Fixed-Dose Combination Therapy Compared To Pioglitazone HCI Monotherapy And To Metformin HCI Monotherapy
A Phase III Randomized, Active Comparator (Pioglitazone) Controlled Trial To Study The Efficacy And Safety Of Sitagliptin And MK-0431A (A Fixed Dose Combination Tablet Of Sitagliptin And Metformin)
A Randomized, Double-Blind Placebo And Active Comparator Controlled Study To Assess The Efficacy And Tolerability Of MK-8141
A Multicenter Randomized Double-Blind Active Controlled Parallel Group Phase III Trial To Evaluate The Safety And Efficacy Of Dapagliflozin 10mg
A Multicenter, Double-Blind Randomized Study To Compare The Efficacy Of 24 Weeks Treatment With Fixed Combination Therapy Of Vildagliptin And Metformin (25/1000mg Bid) Vs Metformin Monotherapy (100mg Bid)
A Multicenter, Double-Blind Randomized Study To Compare The Efficacy Of TAK-491
A Phase III, Double-Blind Randomized, Placebo Controlled Study To Evaluate The Efficacy And Safety Of TAK-491 In Subjects With Essential Hypertension
A Randomized, Placebo Controlled, Double Blind, Phase 3 Clinical Study Investigating The Long Term Safety Of Fezolinetant
A Study On The Efficacy, Safety, And Tolerability Of Cariprazine Relative To Placebo In Participants With Bipolar I Depression
A Study To Evaluate Extrusion Versus Placebo As Induction Therapy In Moderately To Severely Active Ulcerative Colitis (ELEVATE UC 12)
A Study To Assess The Effect Of Tezepelumab On The Immune Response To Influenza Vaccination In Participants With Asthma (VECTOR)
A Study To Assess Efficacy And Safety Of Baloxavir Marboxil In Combination With Standard-Of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Efficacy Of AVTX-002 For The Treatment Of Poorly Controlled Non-Eosinophilic Asthma
A Phase 3 Adaptive Study To Evaluate The Safety And Efficacy Of Inhaled Treprostinil In Participants With Pulmonary Hypertension (PH) Due To Chronic Obstructive Pulmonary Disease (COPD) (PERFECT)
A Research Study To Show The Effect Of Aprocitentan In The Treatment Of Difficult To Control (Resistant) High Blood Pressure (Hypertension) And Find Out More About Its Safety (PRECISION)
A Study To Learn About Two Or More Vaccines That Are Put Together As One Shot Against Infectious Lung Illnesses, Including COVID-19 And Respiratory Syncytial Virus (RSV)
Conversion From High-Dose Full-Opioid Agonists To Sublingual Buprenorphine Reduces Pain Scores And Improves Quality Of Life For Chronic Pain Patients
A Single Blinded Randomized Placebo-Controlled Study Evaluating The Overall Skin Quality And Psychosocial Effects Of A Topical Exosome Pre And Post CO2 Ablative Laser Treatment.
A Double Blinded, Randomized, Placebo-Controlled Trial Evaluating The Use Of Intradermal Botox Injections On Nasal Skin Thickness Of The Tip And Supratip Region In Patients Undergoing Rhinoplasty.
BOTOX® (OnabotulinumtoxinA) For The Reduction Of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.
The Impact Of Applying A Topical Face Mask Containing Carboxytherapy (CO2 Lift) After Undergoing CO2 Laser Resurfacing On The Skin Of The Face.
Topical OX Technology – A Double Blinded Placebo-Controlled Study Of Effects On Interpersonal Interactions, Quality Of Life, Skin And Attractiveness.
An Open-Label, Randomized, Split-Face, Controlled Study On Pain Management With Injection Of Botulinum Toxin For Glabellar Line Correction.
Non-Randomized, Multi-Site, Single-Arm Study Of The LinguaFlexTM Tongue Retractor For The Treatment Of Moderate To Severe Obstructive Sleep Apnea And Snoring In Adult Subjects (LTRTM Trial).
An Open Label Study To Investigate The Safety And Efficacy Of Tradipitant In Participants Affected By Motion Sickness During Travel.
A Phase 4, Open-Label Study To Investigate The Efficacy And Safety Of VTAMA® (Tapinarof) Cream, 1% In The Treatment Of Plaque Psoriasis Occurring In The Head And Neck Region.
A Phase 3, 24-Week, Randomized, Placebo-Controlled, Double-Blind Study To Assess The Efficacy, Safety, And Tolerability Of Rocatinlimab (AMG 451) Monotherapy In Adult Subjects With Moderate-To-Severe Atopic Dermatitis (AD).
A Phase 3, Randomized, 52-Week, Placebo-Controlled, Double-Blind Study With Randomization To Assess The Efficacy, Safety, And Tolerability Of Rocatinlimab (AMG 451) In Adolescent Subjects With Moderate-To-Severe Atopic Dermatitis (AD) (ROCKET-ASTRO).
A Phase 2 Study To Evaluate The Efficacy And Safety Of RPT193 As Monotherapy In Adults With Moderate-To-Severe Atopic Dermatitis.
An Open Label Phase 2 Study To Evaluate The Effects Of A Local Anesthetic, Anti-Inflammatory Medications And Compression Garments On RZL-012-Induced Adverse Events.
PSoSA (Psoriasis Special Areas) – A US-Based, Single-Arm, Prospective, Multicenter, Observational Study Of Nail And Scalp Psoriasis Improvement In Patients Treated With Ixekizumab.
A Phase 1, Multicenter, Double-Blind Study To Evaluate The Sequential Administration Of AGN-151586 And OnabotulinumtoxinA (BOTOX) For The Treatment Of Glabellar Lines.
A Prospective Multicenter Sample Collection Study Using Non-Invasive Methods To Investigate Biomarkers In Pediatric And Adult Patients With Atopic Dermatitis.
A Phase 2, Open-Label, Self-Controlled Study Of Different Interventions To Reduce Bruising Following CCH-Aaes Treatment For Cellulite Of The Buttocks In Adult Females.
A Phase 3, Multicenter, Open-Label Study To Evaluate The Safety Of AGN-151586 For The Treatment Of Glabellar Lines.
(Updated January 31, 2025) Research Capability Statement.pdf