Leaders in innovation
We believe the exceptional is possible when you have the right partner.
Get to know our knowlegeable and experienced team members and their roles in developing and delivering breakthroughs that change lives.
Meet our experts
Michael George
Vice President and Global Therapeutic Area Head
Michael George, MBBS, MRCP, MFPM, is the Global Therapeutic Area Head at Fortrea.
His areas of expertise include global strategic clinical drug development and portfolio and program management across multiple therapeutic areas, including immune-mediated inflammatory diseases (IMIDs), cardiovascular and metabolic diseases and women’s health.
He has more than 25 years of experience in the pharmaceutical and CRO industry, having held numerous posts of increasing seniority across all phases of clinical drug development in various therapeutic areas and pharmacovigilance with both regional and global responsibility. At Fortrea, Michael is responsible for medical portfolio oversight, executive governance and clinical business development. He has authored several articles in the areas of IMID development, hypertension, heart failure, diabetic retinopathy and neuro-endocrine modulation.
Maria Paula Ghirardi, MD
Medical Director Oncology
Maria Paula Ghirardi, MD, is Medical Director of Oncology for Fortrea Clinical Development Services, based in Buenos Aires, Argentina. Dr. Ghirardi has 6 years of Oncology clinical research experience in both pharmaceutical and CRO industry. She provides clinical and medical expertise to project team and other Fortrea departments to advance clients’ drug development programs and contributes to the scientific strategic leadership of the Oncology therapeutic area. She has experience leading important launches of hematology-oncology compounds for multiple myeloma, AL amyloidosis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia.
Dr. Ghirardi earned her medical degree from the University of Buenos Aires and completed her internal medicine residency at the Hospital Ramos Mejia in Buenos Aires and Hematology residency at the Hospital de Clinicas in Buenos Aires and Sociedad Argentina de Hematologia. She joined our company in October 2022.
Susan Gilchrist, MD, MS
Senior Medical Director
Susan Gilchrist, MD, is a Medical Director of CVMER (cardiovascular, metabolic, endocrine and renal) at Fortrea. Dr. Gilchrist is a board-certified cardiologist with more than 15 years of experience treating cardiovascular patients and has formally trained in epidemiology and clinical trial design. As a clinician scientist, she has extensive experience in cardiovascular cohort and clinical trial development and execution and has contributed to over 100 peer-reviewed publications in cardiovascular clinical research.
Dr. Gilchrist has an MD from the University of Texas Health Science Center in San Antonio (UTHSCSA) and completed a cardiology fellowship at Wake Forest University School of Medicine and an internal medicine residency program at UTHSCSA. She earned an MS in Epidemiology and Clinical Research from Wake Forest University Graduate School and a BA from the University of Texas at Austin.
Barbara S. Gillespie, MD, MMS, FASN
Vice President & Therapeutic Strategy Leader
Vice President & Therapeutic Strategy Leader at Fortrea, Board Certified Nephrologist, Adjunct Professor at University of North Carolina, Division of Nephrology & Hypertension and past Associate Medical Director at local dialysis units.
Board of Directors (2018-2023) for the Kidney Health Initiative (a public-private collaboration between the FDA and the American Society of Nephrology). Co-chair of Steering Committee for APOL1 Kidney Disease; work group member (and publication co-author) for Endpoints in IgAN, FSGS, C3G, Peds IgAN and CVO Trial challenges in CKD patients. Steering Committee for NFK CKD Patient Registry (Patient Network) and serves on multiple Advisory Boards and Stakeholder Committees (e.g., NephCure and International Society of Glomerular Disease’s PARASOL for FSGS Endpoints; PREPARE-NS for PROs; NKF Scientific Workshops for Renal Endpoints in Early CKD; Medical Ad Board for Regional NKF, NephCure MN Consensus Group, PCORI, SONG) and invited faculty speaker at many global nephrology conferences.
Collaborating with sponsors since 2006 on renal clinical development programs across 20+ indications in both CKD and End Stage Kidney Disease and associated complications
Evelyn Go, MD
Senior Medical Director
- Senior Medical Director at Fortrea. Board certified internist and nephrologist
- 15 years clinical experience as internist and renal physician including serving as in-house nephrologist at dialysis centers.
- Clinical trial industry related experience since 2009. Collaborating with sponsors serving as project medical lead and scientific advisor on various therapeutic indications including CKD and End Stage Kidney Disease, Lupus Nephritis, hemodialysis study and associated complications
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Phase I Site Partnerships, Selection and Feasibility
As well as the 4 dedicated Fortrea CRU’s in the USA and UK, Fortrea has developed an extensive phase 1 site partnership network of over 290 phase 1 clinical sites.
Our partnerships extend globally, with successful collaborations in regions such as Asia, Europe, and North America, and are supported by dedicated resources such as project management, medical and scientific operations, pharmacy, clinical monitoring, and biometrics.
Healthy subject recruitment is a cornerstone of successful Phase I clinical trials. Our extensive database of almost 155,000 volunteers ensure efficient and high-quality recruitment for phase 1 studies.
Our dedicated recruitment teams, recruitment website and outreach activities streamline the recruitment process. Our clinical pharmacology units are strategically placed in Dallas, Madison, Leeds, and Daytona Beach to access large potential populations, providing a robust infrastructure for Phase I trials.
Dallas: Our Dallas unit boasts a database of over 69,900 healthy participants, ensuring a diverse pool of volunteers for various studies.
Madison: The Madison CRU has a database of 43,700 healthy participants, providing a substantial resource for rapid and efficient recruitment.
Leeds: In Leeds, we have successfully nurtured the details of 13,850 healthy participants, demonstrating our capability to engage volunteers in the UK.
Daytona Beach: Our Daytona Beach clinical research unit has a database of 27,200 healthy participants, ensuring a steady flow of volunteers for clinical trials.
Fortrea’s ability to recruit for small and large cohort studies depends upon our ability to reach out to these individuals quickly and efficiently, and to recruit new potential participants via a dedicated recruitment website, www.fortreaclinicaltrials.com
Fortrea ensures high-quality clinical research through expert medical and clinical monitoring. Our specialists oversee trial progress, protect participant safety, and ensure data accuracy and regulatory compliance. With over 16 years of average industry experience, our physicians and scientists have supported 400+ studies in the last 5 years [2019-2024]. They collaborate closely with clinical teams to provide real-time insights and address medical issues promptly. This integrated approach upholds the highest standards of patient care and data integrity throughout the trial.
- Experienced, in-house team
- On-site medics to support studies
- Experience spanning 400+ successful studies
PK/PD monitoring is vital to understanding a drug’s behavior and effects. Fortrea’s clinical pharmacology team is familiar with the use of advanced tools like liquid chromatography, mass spectrometry, and immunoassays to precisely measure drug levels in small molecules and biologics. We assess drug efficacy and toxicity through PD monitoring, evaluating biomarkers and clinical endpoints to define optimal dosing. Our approach includes non-compartmental and compartmental analyses using data from plasma, blood, urine, and more. We also apply H2 simulation techniques to predict drug behavior and optimize study design, supporting informed decisions throughout the clinical trial process.
Fortrea’s integrated services gives us the ability to deliver Rapid topline PK data, providing sponsors with valuable insights into the pharmacokinetic (PK) properties of an asset, and helping steer decision making about follow-on pharmacology studies and clinical development. By delivering topline PK insights as quickly as 5 days from database lock, we enable sponsors to make timely go/no-go decisions, refine study protocols, and expedite regulatory interactions.
Find out more.
Link to document AR_0007_Rapid PK Data_0424_HiRes (1).pdf
With over 140 impairment studies completed, Fortrea’s renal studies are supported by a dedicated impairment team and a global network of over 25 Phase I-qualified renal sites, ensuring access to both dialysis-dependent and non-dialysis-dependent populations.
These studies are executed with intense medical oversight, centralized IRBs, and a two-step eligibility process, ensuring faster enrollment, increased safety, and high data reliability.
Fortrea’s CRUs in Dallas, Daytona Beach, Madison, and Leeds are equipped for complex procedures like CSF collection, FibroScan®, and cognitive testing, and are supported by cGMP pharmacies and on-site bioanalytical labs.
[Hyperlink to this document – SS_0006_CPS_Impairment Study_0524_HiRes.pdf
…and this article - AR_0009_Renal Impairment_0924_HiRes.pdf ]
Drug-drug interaction studies involve assessing the pharmacokinetic (PK) and pharmacodynamic (PD) interactions between investigational drugs and other medications. This is essential for identifying potential adverse effects and optimizing dosing regimens.
Our dedicated team of medical and scientific experts employs rigorous methodologies to conduct DDI studies, including noncompartmental and compartmental analyses, physiological-based pharmacokinetic (PBPK) modeling, and population PK analysis. These techniques enable us to provide comprehensive insights into drug interactions, supporting informed decision-making throughout the drug development process.
Fortrea has successfully conducted over 90 drug-drug interaction (DDI) studies in the past five years, demonstrating deep expertise in this critical area of early clinical development. These studies span a wide range of therapeutic areas and include both healthy volunteer and patient populations.
Fortrea has conducted over 170 Phase I studies in the past five years, many of which involved large cohorts and complex, combined protocols. These include hybrid SAD/MAD, food effect, and patient-access designs. Fortrea’s CRUs—Dallas, Daytona Beach, Madison, and Leeds—are purpose-built to accommodate high-volume dosing, with 72–100 beds per site and 24/7 operations. Our integrated delivery model, featuring in-house cGMP pharmacies, centralized recruitment, and real-time data capture, enables rapid enrollment and high retention. Over 70% of FIH studies are adaptive, allowing seamless transitions across cohorts and study phases, reducing timelines and maximizing data yield.
Fortrea has conducted 50+ studies involving QT assessments, including Thorough QT (TQT) studies, over the past five years. These studies are supported by intensive cardiac monitoring infrastructure across all Fortrea Clinical Research Units (CRUs), including continuous 12-lead ECG, telemetry, Holter monitoring, and Mortara Surveyor systems.
Importantly, many of these TQT studies are embedded within complex, combined protocols. For example, Fortrea has executed TQT studies that include a SAD (Single Ascending Dose) component within the same protocol, enabling dose selection based on interim safety and PK data. This integrated approach allows for single protocol and regulatory submissions, reducing both time and cost while generating additional exposure data that can support other studies such as renal or hepatic impairment assessments.
Fortrea brings deep expertise in recruiting and conducting Phase 1 studies involving special populations, including elderly, obese, post-menopausal women, and patients with renal or hepatic impairment.
Recruiting special populations is supported by a dedicated impairment team and a network of over 65 experienced sites. These sites are pre-qualified for specific population access and are often located near Fortrea’s CRUs in Dallas, Daytona Beach, Madison, and Leeds. Recruitment is accelerated through:
- Centralized IRBs and streamlined eligibility processes.
- Pre-screened patient databases and partnerships with community clinics.
- Digital outreach and AI-driven feasibility tools to match patients to protocols.
- Multilingual staff and culturally sensitive materials to support diverse populations.
In key therapeutic areas, particularly in oncology, hepatology, and immunology indications, demand for Phase 1b studies with patients is increasing. Fortrea CPS excels in delivering Phase 1b and hybrid studies through a nimble, patient-centric model that integrates therapeutic area expertise with clinical pharmacology precision.
These studies often involve complex designs—such as adaptive protocols and hybrid SAD/MAD/FE/DDI cohorts—executed across Fortrea’s global network of MHRA-accredited clinics and specialized partner sites.
Fortrea has conducted over 100 ethnobridging studies, with more than 3,000 Asian subjects randomized and completed across the US, UK, and Europe. These include SAD, MAD, FE, DDI, AME, and biosimilar studies, often embedded in complex, adaptive protocols. Our long-standing work with UK Chiken Services Ltd (CHIKENGLOBAL) ensures culturally tailored recruitment, translation, and in-clinic support. With a 100% retention rate at our Leeds CRU successful studies in our Dallas clinical research unit in the USA, Fortrea’s integrated model delivers high-quality data and seamless execution for Asian bridging programs—making us a trusted partner for global development.
Food effect studies are essential for understanding how food impacts the absorption, distribution, metabolism, and excretion of drugs, ensuring optimal dosing and efficacy.
Food effect studies involve assessing the drug absorption and pharmacokinetic properties of a drug when administered with food versus a fasted state. This is crucial for determining the best administration guidelines for new medications.
Fortrea Clinical Pharmacology Services (CPS) has conducted at least 60 food effect studies over the past five years, including:
- 21 food effect studies between 2017 and 2021 at the Leeds CRU .
- The Dallas CRU contributed 25 food effect studies in the same period.
- The Daytona Beach CRU added 17 food effect studies.
Fortrea’s Clinical Pharmacology Services (CPS) has conducted over 130 SAD/MAD studies in the past five years across its global Clinical Research Units (CRUs). These studies are foundational to early-phase development, enabling safe dose escalation and pharmacokinetic profiling in healthy volunteers and special populations.
A significant proportion—over 70%—of First-in-Human (FIH) studies at Fortrea are adaptive SAD/MAD designs, often embedded within complex, combined study programs that integrate food effect, DDI, or patient cohorts. These hybrid protocols allow seamless transitions from SAD to MAD phases, and even into proof-of-concept in patients, accelerating timelines and optimizing data collection.
Brian Guthrie, MBA
Associate Director, Strategic Delivery & Growth
Brian is based in Chicago, Illinois, USA and has over 19 years clinical research experience, having worked at several biotech companies, a global CRO and GlobalCare Clinical Trials (acquired by Covance/Labcorp). Brian joined Fortrea in 2020 as a part of the GlobalCare acquisition. He has worn many hats in those years and has hands-on experience in clinical operations, strategic planning and growth, data management, medical writing, project management, portfolio management, line management, business development, contract execution, FDA submissions and working with advisory boards. He has therapeutic experience in Ophthalmology, Women’s Health, Neurology, Rare Disease, Oncology, Cardiovascular and Trauma research and has spent the last 3 years solely focused on Ophthalmology.
Brian is passionate about patient centric clinical trials and finding creative solutions to reduce site and patient burden in a space filled with complex and debilitating disorders.
Laurentiu Gutiu, MD
Executive Medical Director
Dr. Gutiu is a board-certified neurologist with more than 15 years of clinical experience in a hospital setting across a wide range of neurological and psychiatric indications. He spent 10 years in academia as Assistant Professor of Neurology and attended doctoral courses in neuropharmacology. His 25 years of clinical research experience includes roles as an investigator, medical monitor and medical leadership positions spanning Phase I-IV studies.
He has broad range of experience across product modalities, including biologics and cell and gene therapies as well as medical expertise in neuro and psychiatric diseases, including, but not limited to, neurodegenerative, pain, neuromuscular and demyelinating.
Brian Hamilton, MD, PhD
Medical Director
Brian Hamilton, MD, PhD, is Senior Medical Director for Fortrea, based in Newton, Massachusetts. He serves as Fortrea Subject Matter Expert for cellular immune-oncology, CAR-T and gene therapy. He also serves as global lead project physician on clients’ drug development projects. Dr. Hamilton has more than 35 years of experience in pediatric medicine, immunology, hematopoietic stem cell transplantation, and clinical research and development. Before joining Fortrea, he served as Executive Medical Monitor for Chiltern International. He has also held senior-level medical director, director physician, regulatory affairs and clinical research positions with Galena Biopharma, AstraZeneca, Onyx Pharmaceuticals, Wyeth Oncology, and other pharmaceutical and biotech firms. Dr. Hamilton joined our company in August 2018.
Konstantin Haradinov, MD
Medical Director
Konstantin Haradinov, MD, is a Medical Director, Oncology for Fortrea, based in Sofia, Bulgaria. He contributes to the development of Fortrea policies involving medical, safety and therapeutics; serves as global lead project physician and provides medical and safety monitoring on assigned projects; reviews medical data and provides clinical and medical expertise to project teams and other Fortrea departments, and performs safety trend analyses.
Dr. Haradinov has more than 15 years of experience in clinical research as a medical director and physician/oncologist. Before joining Fortrea he served as Medical Officer, Oncology, for Chiltern International in Sofia, Bulgaria. Dr. Haradinov joined our company in April 2019.
David Hoelscher, MD
Senior Medical Director
Dr. Hoelscher is based in Austin, Texas with 24 years of CRO industry experience in a wide variety of therapeutic areas, most recently in the past 16 years focusing on medical monitoring in ophthalmology indications including:
- Retinal: dry/wet AMD, Non-infectious Uveitis, DME, Macular edema in uveitis, Vitreomacular traction, Proliferative/non-proliferative diabetic retinopathy
- Anterior indications: dry eye, Glaucoma/POAG
- Gene therapy: wet AMD, Batten’s disease
- Rare disease: Batten’s disease, choroideremia, Stargardt’s disease, Retinitis Pigmentosa, Leber’s amaurosis
While in medical school, he participated in Parkland Hospital’s “Mavericks in Ophthalmology” program, leading to a long fascination with research and the clinical practice of vision care.
Jingjun (Eric) Huang, MD
Senior Medical Manager
Jingjun (Eric) Huang, MD, is Senior Medical Manager in Fortrea, based in Guangzhou, China. He has 10 years of experience in clinical practice and clinical study in oncology, especially in hepatobiliary cancer. He was a principal investigator and expert reviewer of the National Natural Science Foundation of China and Medical Science Research Foundation of Guangdong Province. He published nine studies as the first/co-first author.
Dr. Huang earned his doctorate degree and bachelors degree in an eight-year program in Clinical Medicine at Sun Yat-sen University. He completed his residency in the Third Affiliated Hospital of Sun Yat-sen University and worked as attending physician in the Department of Interventional Radiology and Minimally Invasive and Interventional Cancer Center and the Second Affiliated Hospital of Guangzhou Medical University. He joined our company in January 2022.
Krane Huang, MD
Senior Director and China Regional Head
Krane Huang, MD, is a Senior Medical Director, China Regional Head of Oncology for Fortrea, based in Shanghai, China. Dr. Krane has nearly 20 years of experience as medical oncologist in cancer hospitals, global pharmaceutical industries and CROs, focused on planning and execution of global oncology clinical development projects in all phases (I-III), different drug types and classes.
Dr. Krane earned his medical degree from Tongji Medical College, Huazhong University of Science & Technology and completed his internal medicine degree and medical oncology fellowship training at Wu Union Hospital. He joined our company in September 2019.
Kazuya Iwamoto, MD, PhD, FACP
Senior Medical Director
Kazuya Iwamoto, MD, PhD, MBA, FACP, is Senior Medical Director for Fortrea in Osaka, Japan. He provides medical and scientific expertise to oncology study teams on clients’ drug development projects and contributes to the development of medical strategies and execution of clinical trials. Dr. Iwamoto has more than 25 years of experience as a physician, research clinician and medical director.
Before joining Fortrea, he was Head of the Medical Division, including Clinical Development and Medical Affairs, for Hospira Japan in Osaka. He previously served as Head of the Medical Division for Biogen Idec, Head of Medical Affairs for Bayer Yakuhin, and Clinical Research Physician for Eli Lilly in Japan. Currently President and Fellow of the Japanese Association of Pharmaceutical Medicine, Dr. Iwamoto joined our company in May 2016.
John Carlsen, MHA
John Carlsen, MHA, is a Vice President who leads the Reimbursement Strategy & Payer Insights service line within Fortrea’s Market Access Consulting and HEOR group. He specializes in assessing the impact of changes to Medicare and managed care payment systems on the reimbursement of drugs, biologics, and devices. He has collaborated with manufacturers on market access strategy projects across many therapeutic areas and has over 20 years of experience with coding, coverage, and payment issues in various settings of care.
John closely follows the latest health care policy developments. Most recently, he has worked with clients in the areas of Medicare drug coding and payment policies, Medicare hospital payment systems (inpatient and outpatient), the Inflation Reduction Act, discarded drug and 340B modifiers, and biosimilars.
Before joining Fortrea (formerly Labcorp and Covance), John worked at the Ohio State University Medical Center in Columbus, Ohio, where he focused on financial management and medical information management.
John earned an MHA in Health Services Management and Policy from Ohio State University’s Graduate Program and a BA in Economics with a minor in Psychology from Duke University.
Juan Jure, MD
Medical Director
Juan Jure, MD, is a Medical Director based in Buenos Aires, Argentina at Fortrea, where he serves as project physician. Dr. Jure brings extensive experience in medical and safety oversight of clinical trials, with a strong therapeutic experience in oncology (solid tumors Phases I-III) and cancer supportive care as well as developing, reviewing, and revising protocols and project-specific tools.
Prior to his current position, Dr. Jure held positions where he gained expertise in medical monitoring demonstrating a commitment to ensuring the safety and well-being of study participants, as well as maintaining high standards of data quality and site compliance.
Dr. Jure holds an MD degree from Universidad Nacional de Córdoba, Argentina, and completed his postgraduate degree in Clinical Oncology at Municipalidad de San Isidro. Furthermore, he has completed a Master's in Business Administration from Universidad del Salvador, Argentina.
Dr. Juan Jure's diverse experience and commitment to patient care, make him a valuable asset in the field of clinical research and drug development. He joined our company in March 2023.
Jeanelle Kam, MD
Medical Director, CPS Medical & Scientific Affairs
Jeanelle Kam, MD, is a trained OB/GYN with more than a decade of CRU drug development experience across multiple indications. As a CPI and Medical Director at the Phase I Dallas CRU, Dr. Kam conducted over 200 trials in BE, DDI, FE, FIH, Japanese Bridging and TQT studies. In 2022, she joined the CPS Medical Scientific Team as a Phase I Medical Monitor. Her expertise in Women’s Reproductive Health include serving as PI on OC-DDI studies, consultation of endometriosis, lactation and post-menopausal studies. She was the lead author for Fortrea’s birth control guidance, “Evidence-Based Guidance for Contraceptive Use in Phase I and Clinical Pharmacology Trials Including Women of Child-Bearing Potential” and presentation of the guidance at the 2015 Annual Meeting for ACCP poster session.
Geoffrey Kannan, PhD, MD
Senior Medical Director
Geoffrey Kannan, PhD, MD, is an Executive Medical Director in the Oncology Therapeutic Area, Head of the Americas Oncology Team, and Lead for the Pediatric Oncology Medical Science Leadership Center. Dr. Kannan also provides medical and scientific governance to Sponsors, supporting development and execution of oncology clinical trials. Dr. Kannan brings more than 25 years of oncology scientific and medical experience to Fortrea. Dr. Kannan trained as a pediatric hematologist/oncologist and pediatric neuro-oncologist and has served at the University of Miami Miller School of Medicine, the University of Texas M. D. Anderson Cancer Center, Dana-Farber Cancer Institute/Boston Children’s Hospital, and on faculty at Harvard Medical School. Dr. Kannan joined Fortrea out of practice as a pediatric neuro-oncologist affiliated with Inova Children’s Hospital and Children’s National Medical Center. At Fortrea Dr. Kannan leads medical and scientific oncology therapeutic expertise and strategic endeavors for Fortrea’s Americas-based oncology physicians, and leads Fortrea’s pediatric oncology initiatives, lending an experienced voice to guide industry partners to bring life-saving therapies to children afflicted with cancer.