循環器
Driving success in cardiology trials from early phase to post approval.
Work with the experts in the design, conduct and management of cardiovascular drug and device trials—from early phase to registrational and post-approval.
Our experience matters
Advance your cardiology drug or device development with our decades of experience working with large pharma, biotech and research organizations.
Strategic partnerships
Leverage our strong connection with advocacy groups, investigators and organizations to ease patient identification and increase awareness of CV trials.
A smarter study
Incorporate a rigorous approach to study design and endpoint selection with significant expertise in the use of imaging, in vitro and digital endpoints.
Reduce variability and increase efficiency for smarter cardiology trials
Whether you need support with early phase adaptive trial design, site selection, patient identification or targeted services for late-phase outcomes trials, you can trust our expertise. Help minimize variability with our proprietary endpoint approach that uses 6MWT and CCTA to provide a robust training process to enable efficient trials.
With recent and relevant experience in a large portfolio of CV trials from early phase to registrational, including atherosclerotic cardiovascular disease, heart failure and cardiomyopathies, hyperlipidemia, acute coronary syndromes (STEMI/NSTEMI), cardiovascular devices, dyslipidemia, arrhythmias including AF, and many more, we have the know-how to advance your cardiovascular development needs.
Cardiovascular experience that matters
In the last 5 years, we have supported:
主な適応症
- Atherosclerotic cardiovascular disease (ASCVD)
- Heart failure and cardiomyopathies
- Hyperlipidemia
- Acute coronary syndromes
- Cardiovascular devices
インサイト
Get the latest updates from our cardiovascular team
Exceeding challenging milestones through teamwork and innovation
This case study delves into meeting and exceeding trial milestones on very short timelines.
ケーススタディをダウンロード
多様性と受け入れを推進することで、革新的な心臓医療機器へのアクセスを促す
Fortrea's efforts in promoting access to innovative cardiac medical devices, aiming to improve cardiovascular health through cutting-edge technology.
詳細はこちらからStrategies and solutions that make a difference
Beyond our novel solutions, industry-leading processes and subject matter expertise for your cardiovascular trial, you can:
- Enhance site selection and maximize patient recruitment with Xcellerate®. Utilizing trial data with extensive central laboratory data and other data sources, we help enhance your CV trial enrollment and retention
- Train and qualify sites in your imaging and protocol procedures with close collaboration with core labs
- Benefit from adjudication that results in more robust data for DMC/DSMB safety reviews—and no delays to database lock—with Endpoint “fast track strategies”
当社の専門家
Delivering cardiovascular leadership
優れたパートナーシップは、経験豊富なチームから始まります。 Browse the bios of our featured team members.
Cheerag Shirodaria, MD
バイスプレジデント
Dr. Cheerag Shirodaria is the Vice President and Cardiovascular/Metabolic Therapeutic Area Head at Fortrea. He has over 25 years of clinical experience as an interventional and clinical cardiologist and remains on the Faculty at Oxford University Hospitals. He is an expert in cardiac imaging, having completed his doctoral thesis at the University of Oxford on the role of cardiovascular MRI in the evaluation of vascular function. He is also co-director of the coronary computed tomography angiography (CCTA) service in Oxford. He is also co-founder and Chief Development Officer of Caristo Diagnostics, an AI image analysis company that has developed proprietary AI image analysis technology that quantifies cardiometabolic risk associated with coronary inflammation plaque and adipose tissue characteristics. He has supported multiple companies through regulatory interactions, protocol development and Scientific Advisory Board interactions.
Dr. Shirodaria received his medical degree from St. Bartholomew’s Hospital Medical College in London, his medical doctorate from the University of Oxford and his MBA from London Business School.
Ines Pagel-Langenickel, MD
Executive Medical Director
Ines Pagel-Langenickel, MD, is an Executive Medical Director of CVMER (cardiovascular, metabolic, endocrine and renal) at Fortrea. As a cardiologist, she has over 18 years of clinical research experience and has served as a principal investigator and co-investigator in several Phase II and III CV trials. Dr. Pagel-Langenickel's areas of expertise include heart failure, myocardial infarction, CV outcomes, atrial fibrillation, cardiac amyloidosis, stem cell therapy as well as extensive experience with CV outcomes trials and endpoint adjudication.
Dr. Pagel-Langenickel has an MD from Humboldt University of Berlin, completed a postdoctoral fellowship at NHLBI/NIH and earned an MBA from Mannheim Business School.
Susan Gilchrist, MD, MS
シニア医療ディレクター
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.
Lillian M. Dampman, PhD
Senior Director, Strategic Delivery and Growth
- Over 35 years of experience in clinical research development with progressive positions in clinical operations starting as a CRA to leadership roles that led to NDA submissions
- Conducted medical and scientific reviews across multiple therapeutic indications to identify study risks and provide solutions for trial implementation
- Applies data-driven, analytic and innovative approaches in building the global clinical strategy and planning for Phases Ib-IV trials in renal therapeutic areas of various study designs and goals
- Broad therapeutic expertise including rare glomerular and non-glomerular diseases, acute and chronic conditions, in-patient or out-patient studies, and outcome trials
- Based in the United States
Peter Alfinito 博士
Executive Director, Strategic Delivery and Growth
Peter has more than 20 years advancing drug development in the pharmaceutical industry and been with Fortrea (formerly Labcorp and Covance) for nine years. Peter has designed the clinical plan for more than 25 MASH/MASLD (metabolic dysfunction-associated steatohepatitis and metabolic dysfunction-associated steatotic liver disease) trials ranging from Phase Ib through Phase III/IV. He also brings experience in rare liver diseases such as Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. Peter maintains key relationships for Fortrea with liver industry experts and networks to facilitate the smooth transition of trials, spanning the design stage to the operational stage.