Endocrine & Metabolic Focused Research

Endocrine & Metabolic Focused Research Leverage Omega Research's cross-functional expertise in Endocrinology & Metabolism to enhance the efficiency and impact of your clinical development and real-world evidence programs.

Establishing Efficiencies in Endocrine & Metabolic Research

Endocrine and Metabolic diseases represent a rapidly expanding frontier in clinical research. The high demand for novel therapies faces challenges in patient recruitment, complex trial design, and the need for robust safety data. Omega Research successfully navigates these operational and regulatory complexities with deep therapeutic expertise and a proven track record in both interventional trials and observational studies. We specialize in recruiting difficult-to-access patient populations, including those with type 1 and type 2 diabetes, stringent HbA1c criteria, lipid disorders, obesity, and rare endocrine conditions like Cushing's syndrome and acromegaly.

The Omega Research Advantage for Endocrine & Metabolic Studies

Partner with Omega Research to leverage our integrated medical expertise, global regulatory knowledge, and operational excellence. We develop custom strategies that expedite study start-up, enhance patient engagement, and generate the high-quality data needed to accelerate the development and commercialization of life-changing therapies.

Our Experience in Metabolic Diseases

Omega Research has a solid foundation in managing and supporting complex studies in the metabolic space. Our team's cumulative experience encompasses a wide range of study designs and patient populations across our global network.

Our project experience includes focus on 

  • Obesity & Weight Management
  • Diabetes Mellitus (Type 1 & Type 2)
  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)
  • Lipid Disorders & Dyslipidemia
  • Thyroid Disorders
  • Rare Endocrine Diseases

Obesity & Metabolic Disorder Expertise

Building on our extensive phase IV and RWE experience, Omega Research provides comprehensive support for obesity and metabolic studies. Our medical, operational, and regulatory staff understand the intricacies of these trials from multiple perspectives—sponsor, patient, investigator, and regulator. Our mature relationships with global thought leaders, specialized investigative sites within our global network (including direct presence in Türkiye, TRNC, USA, and Kosovo, and partnerships in the EU and MENA), and knowledge of effective patient retention strategies ensure efficient and high-quality enrollment, which is critical to the success of your program.

Comprehensive Medical, Regulatory, and Operational Expertise

Our core strength lies in our therapeutically-aligned teams. In-house medical experts and advanced clinical practitioners provide strategic input on study design, endpoint selection, and feasibility. They train operational staff, work directly with investigators, provide diligent medical monitoring, and support interactions with regulatory agencies (EMA, FDA, TİTCK).

Operationally, we pride ourselves on rapid study start-up, proactive risk-based monitoring, and successful recruitment and retention strategies tailored to endocrine and metabolic patient populations. Our regulatory affairs experts guide you through complex approval processes, leveraging our knowledge of both international and local requirements.

Integrated Central Laboratory & Biomarker Support

While we partner with leading central laboratories, our role is to ensure seamless integration. We have vast experience in managing the specific biomarker needs of endocrine and metabolic trials. Our experts assist in selecting the most relevant biomarkers—such as HbA1c, fasting glucose/insulin, HOMA-IR, IGF-1, cortisol, and other specialized assays—and in designing efficient sampling and logistics plans to ensure data integrity from site to database.

Advanced Imaging & Core Lab Coordination

For studies requiring objective imaging endpoints, Omega Research provides expert coordination with specialized core labs. We have experience in integrating imaging for metabolic disorders such as MASH, obesity, and diabetes complications.

We facilitate

Coordination with board-certified radiologists for complex MRI-PDFF (hepatic fat fraction) and MR Elastography (liver fibrosis) assessments.

Management of DXA scans for body composition analysis (lean mass vs. fat mass) and bone mineral density.

Site qualification and training to ensure standardized image acquisition across all study locations in our global network.

Real-World Evidence (RWE) & Post-Marketing Studies

Beyond clinical trials, Omega Research excels in generating real-world evidence. We design and execute post-authorization safety studies (PASS), treatment pattern analyses, and comparative effectiveness research (CER) in real-world populations with diabetes, obesity, and other metabolic diseases. This provides crucial insights into long-term safety, effectiveness, and healthcare utilization in diverse clinical practice settings.

Real-World Evidence (RWE) & Post-Marketing Studies

Beyond clinical trials, Omega Research excels in generating real-world evidence. We design and execute post-authorization safety studies (PASS), treatment pattern analyses, and comparative effectiveness research (CER) in real-world populations with diabetes, obesity, and other metabolic diseases. This provides crucial insights into long-term safety, effectiveness, and healthcare utilization in diverse clinical practice settings.

QUOTE

The field of endocrinology is evolving rapidly with new therapeutic targets and a greater emphasis on personalized medicine. Our team is dedicated to designing and executing studies that not only meet regulatory standards but also capture the real-world value of these innovations for patients, physicians, and payers.

Cardiac Safety & ECG Core Lab Integration

Recognizing the heightened cardiovascular risk in many endocrine and metabolic conditions—especially with new therapeutic classes—we offer integrated cardiac safety services. We manage Thorough QT (TQT) studies and proactive ECG monitoring in compliance with ICH E14 and other relevant guidelines. A key component of our approach is the seamless integration of wearable rhythm ECG monitors (e.g., patch-based devices, Holter monitors). These technologies allow for continuous, ambulatory cardiac monitoring in real-world and clinical trial settings, capturing sporadic arrhythmias and providing robust data on heart rate variability and arrhythmic burden that traditional intermittent ECG snapshots might miss. Our collaboration with specialized ECG core labs ensures precise data acquisition and analysis from these devices. The high-fidelity data is interpreted by cardiology experts in the full context of the clinical study, providing a comprehensive cardiac safety profile for your compound. This is particularly critical for:

  • Obesity drugs with potential cardiovascular effects.
  • Diabetes therapies where cardiovascular outcomes are a key focus.
  • Rare endocrine drugs that may impact electrolyte balance and cardiac function.