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Monitoring and Investigator Assistance in Clinical Trials

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Providing Effective Clinical Monitoring in Raleigh, NC

Based in Raleigh, North Carolina, Glenwood Clinical Monitoring, Inc. specializes in performing and coordinating all aspects of the clinical monitoring process.

The company and our strategic affiliates provide timely, cost-efficient, and accurate monitoring services to assess the safety and efficacy of investigational trials.

The company emphasizes a dedicated and personalized approach to clients and their affiliates. We demonstrate a high-standard of expertise, courtesy, and professionalism. We understand that clear communication and professional rapport with our clients, partners, and investigators is critical to ensure the success of studies.

Our Services

Services include developing monitoring plans, conducting site evaluation and initiation visits, conducting site visits to determine protocol and regulatory compliance, case report form review, central and investigator file reviews, performing investigational product accountability, preparing pre/post site visit required documentation, data query resolution, monitoring PK / PD biomarker studies (SAD-MAD), AE / SAE reporting documentation, and helping clients meet critical study timelines. Other services are available including business development, training, auditing, and Investigator assistance.

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Monitoring

We specialize in performing and coordinating all aspects of the clinical monitoring process.

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Investigator Assistance

Our team assists investigators who may need additional guidance with study operation planning.

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Sponsor/CRO Oversight

We support project management services to sponsors and CROs with comprehensive clinical monitoring.

Why Choose Us

Our team dedicates themselves to helping our clients and partners advance effective therapeutics to the public. That is why we employ a proactive and conscientious approach in everything that we do.

Principal Monitor

Principal Monitor - Cyrus N. Gill, RN, MS, CCRA

  • Graduate of Clinical Research Management from Drexel University College of Medicine
  • Advarra IRB (previously Schulman IRB) Non-affiliated, Scientific, Board Member since August 2017
  • Wide range of Sponsor / CRO monitoring experience since 2004

THERAPEUTIC EXPERIENCE

Infections/Parasitic Diseases: Pediatric RSV / PIV3 – Phases I, II, & III, Candidiasis

Endocrine/Metabolic: Growth Hormone Instruction, Diabetes – Phase II

Circulatory: Hypertension; Neonatal BP support, Pediatric Rehydration, Stem Cell, Cardiac Biomarker and Enzyme Studies (IVD) – Troponin; BNP, Cardiac DES (Paclitaxel) Stent - Device Study

Respiratory: Premature Lung Development, Chronic Lung Disease, Bronchopulmonary Dysplasia, PPHN, assisted-ventilation, Neonatal Resuscitation, Asthma - Phase II, Idiopathic Pulmonary Fibrosis - Phase II

Digestive System: Neonatal Feeding Intolerance, NEC, Gastritis, GI Reflux – Phase II

Renal: Acute Renal Injury Biomarkers (IVD); Renal Dysfunction – Phase I

Oncology: Non-Hodgkin’s Lymphoma – Phase III; High Grade Glioma – Phase I

Treatment with Toca FC, Extended-Release 5-FC

Ophthalmology: Macular Edema – Phase II; Geographic Atrophy related to Dry AMD - Phase IIb/III

Orthopedic: INFUSE®, Medtronic’s recombinant bone morphogenetic protein-2 (rhBMP-2) product

Immunology: Chronic Inflammatory Disease – Phase I

Dermatology: Facial Wrinkles, Keloids, Psoriasis, bullous pemphigoid, pemphigus vulgaris – Phases I, II, & IV

Analgesia: Prolonged Postoperative Analgesia – Phase III

Women’s Health: Recurrent Vulvovaginal Candidiasis – Phase III, Endometriosis, Oral Conceptive – Phase I, (IVD-Medical Device Studies for Pre-eclampsia & Pregnancy), Non-incisional permanent birth control (female sterilization) – Phase: Pivotal Device

CERTIFICATIONS, LICENSES & MEMBERSHIPS

  • RN License, State of North Carolina with Multi-State Privileges
  • Member of Association of Clinical Research Professionals (ACRP)
  • Certified Clinical Research Associate (ACRP) as determined by The Academy’s FDA CRA Exam Committee
  • Advarra Institutional Review Board (Formerly Schulman lRB)

Get in Touch

Our office is located near Research Triangle Park in Raleigh, NC. If you have inquiries or concerns about us and what we do, feel free to set an appointment or answer the form below.

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