General Medicine

The highest quality delivery through foresight and accountability

Our general medicine thought leaders provide innovative development strategies and principled trial design and conduct.  They work hand in hand in with market access and regulatory experts, operational teams, and feasibility leaders to ensure that your trials are conducted to exacting standards. General Medicine M.D.s are keenly focused not only on today’s landscape but what the future portends, providing both strategic insight and operational nimbleness across all phases of development.


 

Get focused support, no matter the size of the study

Our General Medicine group has global expertise in cardiovascular medicine, respiratory medicine, endocrinology and metabolic diseases, nephrology, and women’s health and genitourinary medicine.

Because the needs of patients are at the core of all that we do, each program, from highly prevalent conditions to ultra-rare diseases, and from mega trials with thousands of patients, to trials with very few patients, receives our focus. But we do not just execute. We seek and scrutinize the latest advances in study design and technologies to catapult your program to success.  

Experience in the past 5 years with general medicine

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clinical projects
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enrolled patients
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sites

Cardiovascular

We have far-reaching experience in cardiovascular trials across the entire spectrum of drugs and medical devices, including heart failure, hypertension, pulmonary hypertension, atherosclerosis and myocardial infarction, atrial fibrillation, and thrombosis, to name a few. Our board-certified cardiologists, top-notch biostatisticians, and regulatory, product development, and market access specialists are always ready to optimize study designs and develop strategy.

Two additional strengths are our adjudication services and site and ECG/imaging core laboratory networks. Our adjudication services help ensure the highest quality data, and because we are already engaged in cardiovascular projects across our site network, we’re able to accelerate timelines with our experience and agreed upon contract templates, as well as monitor sites closely to ensure high performance.

Lazar Mandinov, M.D., Ph.D.

Global TA Section Head, Cardiovascular

Michelle Wilson, M.D.

Medical Director

Sheila Banks

Clinical Operations Leader

Iakov Lisenko

Senior Project Leader

Endocrinology and metabolism

Our projects cover the spectrum from small studies of rare metabolic diseases to Type 2 diabetes mega-trials enrolling thousands. We fulfill the unique needs of each study with strong site networks around the world and recruitment solutions, including both adult and pediatric studies. Sensor solutions for diabetes studies are another area of our expertise, including 21 Code of Federal Regulations (CFR) part 11–compliant continuous glucose monitoring (CGM). Our sensor solutions and endocrinology experts have collaborated on solutions to facilitate CGM and glucose-related data capture for diabetes clinical trials. Through partnerships with our vendors, we can offer an integrated central platform for real-time visualization and monitoring of CGM, blood glucose and e-diary information.

Our team includes board-certified adult and pediatric endocrinologists, certified clinical densitometrists, glucose-clamp expertise, and top-quality regulatory, market access, and biostatistics experts.

Shipra Patel, M.D.

Global TA Section Head, Endocrinology

Viviana Reidel, M.D.

Senior Medical Director

Aoife McKeon, Ph.D.

Senior Project Leader

Octavian Alexe

Clinical Operations Leader

Nephrology and genito-urinary

As we enter a new era with breakthroughs for chronic kidney and urinary system diseases, we are here to help you overcome obstacles — like patient recruitment, payer engagement, and others. Our delivery of major studies in this area demonstrates expertise, including chronic kidney failure, diabetic and polycystic kidney diseases, nephritis, nephropathy, urinary incontinence, overactive bladder, and benign prostatic hyperplasia.

Harmeet Singh, M.D.

Senior Medical Director, Global TA Head, Nephrology

Maaliddin Biruar, M.D.

Senior Medical Director

Iakov Lisenko

Senior Project Leader

Respiratory

From the millions of individuals affected by asthma and COPD to the few affected by rare diseases, bringing innovation and more affordable treatments to patients is our passion. At Parexel, we have conducted studies in common repsiratory processes involving many thousands of patients at more than 3,000 sites globally, including one of the largest observational asthma trials ever conducted. Likewise, our expertise spans to smaller studies in interstitial lung disease, cystic fibrosis, chronic cough, and orphan diseases.

Through partnerships with the leading pharma companies and biotech innovators, we collaborate across the full ecosystem of respiratory disease research. As a single point of contact, we integrate meaningful data to assess treatment efficacy in an interventional trial and relevant insights in the real world of respiratory disease.

Anthony Bohnert, M.D.

Global TA Section Head, Respiratory

Irina Bondarenko, M.D., Ph.D.

Senior Medical Director

Zeina Karam-Absi, M.D.

Senior Medical Director

Kathy O'Neill

Senior Project Leader

Women’s health

While the ecosystem for women’s health drug development and marketed products has become increasingly complex, we have the experience and success to drive your trials forward. Our expertise spans across a person’s lifetime, encompassing preadolescent care, menstrual and pelvic health, contraception, fertility management, pregnancy, menopausal care, and mental health. We continue to be at the cutting edge of women’s health, supporting all three women’s health products approved by the US FDA in 2020. As the field of women’s health moves beyond patients, health care providers, pharma, payors, and regulators, we are ready to partner with you to accelerate product development.

Nancy Kivel, M.D.

SVP, Medical Sciences

Robert Joseph, M.D.

Medical Director

Advantages

Innovative trial designs and technology

At Parexel, we have vast expertise in innovative trial design and digital medicine. This includes virtual, decentralized, and adaptive trials, precision and translational medicine, and sensor solutions, which can make your trials not only more accessible, but more impactful.

Highlights


Therapeutic insights

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