Mila Grieg, MD, PhD
Vice President, Medical Affairs,
ACE Therapeutic Strategy Head,
Cardiometabolic
Cardiometabolic Disease
SCROLL
A Specialty CRO Advancing Cardiometabolic & Endocrine Research
Driving Innovation in Cardiovascular, Metabolic and Endocrine Clinical Development
Cardiometabolic diseases are the leading cause of death worldwide, requiring rigorous drug development. Allucent works with biopharma and medtech sponsors to advance cardiometabolic therapies and medical devices through the complete clinical development lifecycle from preclinical research to late-phase and post-marketing trials. With extensive experience in cardiovascular disease, type 1 and type 2 diabetes, obesity, dyslipidemia, metabolic syndrome, and associated complications like chronic kidney disease, Allucent stands out as a cardiometabolic CRO. We understand regulatory expectations, endpoint strategies, and operational challenges in large-scale outcome trials and targeted mechanistic studies.
Our endocrinology expertise includes common hormonal disorders and very rare, highly specialized conditions. These trials often demand customized clinical strategies, specialized site networks and most importantly, a patient-centric approach that addresses small, dispersed populations with complex disease biology. We have experience conducting studies for thyroid disorders, adrenal diseases, and pituitary dysfunction, including rare endocrinology indications such as acromegaly, hypoparathyroidism and Cushing’s disease, which allows us, as an endocrinology CRO, to combine therapeutic expertise with adaptive delivery models.
End-to-End Cardiometabolic CRO Services
- Clinical development strategy (Phase I-IV planning)
- Protocol design, endpoint strategy and dose optimization
- Regulatory and drug development consulting
- Regulatory and clinical strategy for medical devices
- Clinical pharmacology studies
- Global site feasibility and site activation
- Patient recruitment and retention strategies
- Decentralized and hybrid trial capabilities
- Imaging, biomarkers, composite scoring and lab support
- Cardiovascular safety, including QT evaluation, risk monitoring
- Pharmacovigilance and safety services
- Real-world evidence (RWE) and post-marketing studies
Addressing the Complexity of Cardiometabolic Clinical Trials
As a cardiometabolic CRO, Allucent delivers end-to-end support for cardiovascular, metabolic, and endocrinology trials, from preclinical to pivotal, with strengths in global site activation, endpoint strategy, and complex patient populations.
160+
Cardiometabolic Studies
2700+
Global Sites
17735+
Cardiometabolic Patients Recruited
50+
Countries
Bringing new cardiometabolic and endocrine therapies to light
Our clinical trials expertise includes complex cardiovascular outcomes trials (CVOTs), adaptive designs, early-phase first-in-human (FIH) and proof-of-concept to large pivotal global trials, and post-marketing studies. With hands-on experience in managing comorbid patient populations, tech-enabled data-driven feasibility, rapid global site activation, advanced endpoint strategies, and real-time monitoring, we support biopharmaceutical and medical technology innovation. With extensive scientific and operational expertise, Allucent serves as a cardiometabolic CRO supporting clinical trials across cardiovascular, metabolic, and endocrinology indications through all phases of clinical development. Our portfolio encompasses cardiovascular research including 16+ hypertension trials amongst other cardiovascular conditions, metabolic development supported by 28+ diabetes trials along with diverse metabolic indications, and endocrinology expertise demonstrated through 12+ acromegaly trials as well as a range of additional rare and complex endocrine diseases.
Therapeutic Focus Areas
Cardiovascular Diseases
- Acute Coronary Syndromes (ACS)
- Arrhythmias
- Heart Failure
- Hypertension
- Peripheral Artery Disease (PAD)
- Pulmonary Artery Hypertension (PAH)
Metabolic Disorders
- Atherosclerosis
- Chronic Kidney Disease (CKD)
- Dyslipidemia and Familial Hypercholesterolemia
- MASH/MASLD
- Obesity and Metabolic Syndrome
- Type 2 Diabetes and Diabetic Complications
- Uremic Cardiomyopathy
Endocrine Disorders
- Acromegaly
- Autosomal Dominant Hypocalcemia with Hypercalciuria (ADHH)
- Cushing’s Syndrome
- Hyperthyroidism
- Hypothyroidism
- Parathyroidism
- Prader-Willi Syndrome
Top Challenges in Cardiometabolic Drug Development and How We Help
Patient Heterogeneity and Recruitment Complexity
Cardiometabolic diseases rarely exist in isolation. Clinical development for these conditions is complicated by patient heterogeneity, as populations differ widely in age, ethnicity, genetic background, and disease severity. Patients often present with comorbidities since conditions such as diabetes, obesity, and cardiovascular disease often coexist. Additionally, lifestyle factors introduce further variability, while certain endpoints (e.g., weight loss) are particularly prone to high placebo responses. This complexity makes patient recruitment and retention challenging. As a cardiometabolic CRO, we design trials that implement site-specific recruitment and engagement strategies through our established global site networks to enroll diverse patient populations.
Early-Phase Design and Decision-Making
Early-phase cardiometabolic trials require careful consideration for dose selection and biomarker integration. Rapid and effective decision-making is crucial to reduce risks in these studies. We support first-in-human (FIH), proof-of-concept, and Phase I/II trials with adaptive designs and integrated biomarker strategies to accelerate development and enable informed decision-making.
Proven success with biotech sponsors: First-in-human (FIH) clinical evaluation of a GLP-1 agonist for obesity in patients with type 2 diabetes, supporting early design and development.
Regulatory Expertise and CVOT Requirements
Cardiometabolic clinical development includes large, longer-duration studies such as cardiovascular outcomes trials (CVOTs) with strict safety and endpoint requirements to ensure efficacy. We provide strategic regulatory expertise and guidance for end-to-end support in CVOT design, while simultaneously ensuring alignment with regulatory requirements and eventual submission.
Proven success with biotech sponsors: CVOT design and regulatory submission support for a lipid-lowering therapy.
Endpoint Strategy and Data Surveillance
Endpoint strategy and selection are complex and intricate parts of cardiometabolic clinical development. It needs to include composite endpoints along with competent data surveillance, management and operation execution for studies involving cardiovascular, metabolic and endocrine conditions. We integrate advanced strategies for endpoint selection and proactive data surveillance to protect your key endpoints by detecting risks early, guaranteeing high-quality, reliable and fit-for-purpose, submission-ready data.
Proven success with biotech sponsors: Global Phase II study in metabolic dysfunction-associated steatohepatitis (MASH), incorporating cardiovascular risk stratification and advanced endpoint analysis.
Safety-Monitoring and Long-Term Risk Management
Cardiometabolic clinical development requires strict safety considerations because therapies are administered chronically to large populations, including stable patients. Even small increases in risk for cardiovascular events, or other complications such as liver toxicity and pancreatitis can affect the population. Thus, regulatory authorities require extensive long-term data and cardiovascular outcomes trials to rule out adverse events. Allucent ensures continuous risk monitoring through robust, tech-enabled, efficiency-driven drug safety and pharmacovigilance solutions.
“In a fiercely competitive cardiometabolic and endocrinology landscape, biotech innovators need expertise and agility to move fast. Allucent delivers, driving quality execution, strong enrolment, and on-time milestones across every stage of development, with patients always front of mind.”
Mila Grieg, MD, PhD
Vice President, Medical Affairs, ACE Therapeutic Strategy Head, Cardiometabolic
Meet Our Cardiometabolic Experts
Partner with our leading cardiometabolic and endocrinology experts to accelerate your clinical development program with operational excellence, scientific rigor, and regulatory expertise.
- 20+ years of professional experience in clinical research and 10 years of experience as a physician
- Deep expertise in Immunology & Inflammation, Cardiometabolic & Endocrinology, and Infectious Disease
- Scientific advisor for global development programs, including asset positioning, indication prioritization, evidence-generation strategies, and regulatory interactions
Sugato De
Sr. Vice President,
Product Development Consulting
- Previous Branch Chief and Senior Policy Advisor with FDA’s Center for Devices and Radiological Health
- Expertise in regulatory and clinical strategy with deep experience in combination products, medical devices, digital health, and companion diagnostics
Evgenia Stankova, MD, PhD
Senior Director,
Global Project Leadership
- Extensive experience spanning clinical research and medical practice, including 25+ years in clinical research and 20 years as a physician
- Deep therapeutic expertise spanning Cardiometabolic & Endocrinology, Immunology & Inflammation, and Infectious Diseases
- Proven leadership in managing global clinical trials, driving operational excellence, and building strategic client relationships
Neda Vesic, MD
Medical Director,
Medical Affairs
- 20 years of professional experience in clinical research and biopharmaceuticals
- Deep expertise in Immunology & Inflammation, Cardiometabolic & Endocrinology, and Infectious Diseases
- Extensive experience as a medical director overseeing clinical development programs, with a recent primary focus on rare endocrine disorders, including acromegaly and Cushing’s disease, among other indications.
Related Content
Additional Resources
Frequently Asked Questions About Cardiovascular and Metabolic CRO
It's a dedicated group within Allucent clinical, regulatory, data, and operational experts who specialize specifically in cardiovascular, metabolic and endocrine disease. They're involved from day one, which means faster decisions and fewer surprises down the line.
We work across cardiovascular diseases, metabolic disorders and endocrine disorders including heart failure, hypertension, obesity, Type 2 diabetes, MASH, Acromegaly, and cardio-renal syndromes. If your asset sits at the intersection of heart and metabolic health, we've likely worked in that space before.
Cardiometabolic trials rarely have straightforward eligibility criteria. We utilize technology-enabled data-driven site feasibility, disease-specific registries, and established global investigator networks to find the right sites and patients faster, without compromising on the quality of who gets enrolled.
Yes. Our regulatory team has direct experience with CVOT design, protocol alignment with FDA and EMA expectations, and full dossier development. We also support QT evaluation and cardiovascular risk monitoring throughout the trial.
These trials involve a lot of moving parts including imaging, biomarkers, lab assessments, and long-term follow-up. We bring all of that together under a unified data strategy and work closely with core labs to train and qualify sites on imaging and other protocol-specific procedures.
Yes. We offer decentralized and hybrid trial capabilities that are built into the protocol design from the start, which is especially useful for long-duration cardiometabolic studies where reducing patient burden directly supports retention.