For over two decades, PROMETRIKA, LLC has been a trusted partner in the biopharmaceutical and medical device industries, providing innovative clinical research services that help shape the future of healthcare. Based in Cambridge, Massachusetts—a hub for biotechnology research—PROMETRIKA has established itself as a global, full-service Clinical Research Organization (CRO) that offers tailored, high-quality solutions to clients worldwide. With its roots firmly planted in a collaborative research environment, the company excels in clinical operations, data management, biostatistics, medical writing, pharmacovigilance, and regulatory submissions.

Empowering the Biopharmaceutical Industry with Expertise and Innovation

Since its inception in 2003, PROMETRIKA has provided unparalleled service to both local and international clients, consistently helping them navigate the complexities of clinical trials and drug development. With a deep understanding of the challenges faced by the biopharmaceutical industry, the company remains at the forefront of delivering exceptional clinical research services.

PROMETRIKA’s team of experienced professionals is committed to ensuring high-value deliverables without compromising quality or efficiency. The company offers comprehensive clinical support, from program planning and protocol development to regulatory interactions and market entry strategies. By leveraging its extensive expertise in rare diseases and specialized clinical trials, PROMETRIKA provides a crucial advantage to sponsors facing the unique challenges of these highly complex and specialized areas.

Flexibility and Responsiveness: Key to Timely, On-Target Deliverables

PROMETRIKA’s size allows it to remain flexible and highly responsive to client needs. Whether clients require stand-alone services or full-service solutions, the company tailors its offerings to meet specific project goals and time-sensitive budgetary constraints. PROMETRIKA understands the pressures that come with clinical trials, and its scalable approach ensures that clients receive the attention and resources they need to successfully complete their projects.

With an emphasis on delivering on-target, on-budget results, PROMETRIKA maintains rigorous internal quality control standards and strives for transparency in all clinical and business processes. This commitment to quality is reinforced by the company’s practice of not subcontracting services except for monitoring outside of North America, ensuring that all services meet their exacting standards.

Unmatched Accuracy: The Foundation of Clinical Excellence

At PROMETRIKA, accuracy is not just a goal; it’s a commitment that guides every aspect of its operations. From clinical operations to data management and biostatistics, PROMETRIKA’s team adheres to strict quality control procedures, ensuring the highest level of accuracy in all deliverables. By maintaining a highly trained staff and fostering a culture of transparency and integrity, the company builds trust and credibility with its clients.

The quality of PROMETRIKA’s work is evident in its success across a broad range of services, from adaptive design consultation and clinical program strategy development to regulatory affairs and inspection readiness support. The company’s deep industry knowledge and dedication to delivering accurate, reliable results make it a standout player in the clinical research field.

Extensive Service Offerings to Address Every Need

As a full-service CRO, PROMETRIKA offers an extensive range of services designed to meet the diverse needs of the biopharmaceutical and medical device industries. The company provides support across the entire clinical trial lifecycle, including:

• Clinical Operations: PROMETRIKA’s experienced team manages all aspects of clinical trials, from site selection to monitoring and reporting.
• Data Management: The company uses advanced data management techniques to ensure the accuracy and integrity of clinical trial data.
• Biostatistics: PROMETRIKA’s biostatisticians provide statistical consulting, analysis, and modeling to ensure that trial results are scientifically sound.
• Medical Writing: The company offers expert medical writing services, from regulatory submissions to clinical study reports and publication-ready manuscripts.
• Pharmacovigilance: PROMETRIKA ensures the safety of participants by monitoring and reporting adverse events in compliance with regulatory requirements.

With these capabilities, PROMETRIKA offers clients a comprehensive suite of services designed to address every need of a clinical trial, enabling them to make informed, timely decisions and successfully bring new therapies to market.

Shaping the Future of Clinical Research

PROMETRIKA has built a reputation as a leader in the clinical research field, offering tailored, high-quality solutions that help sponsors navigate the complexities of the biopharmaceutical and medical device industries. With over 20 years of experience, the company continues to innovate and adapt, providing cutting-edge services that ensure the success of its clients’ clinical trials.

With a steadfast commitment to excellence and a deep understanding of the biopharmaceutical landscape, PROMETRIKA is poised to continue shaping the future of clinical research for years to come.

Miganush Stepanians, PhD | President & CEO

Dr. Miganush Stepanians is the President and CEO of PROMETRIKA, which she founded in 2003. Dr. Stepanians has more than 30 years of experience in drug development, with a specific focus on biostatistics and data management. In addition to overall responsibility for the company’s scientific and operational activities, Dr. Stepanians is a practicing biostatistician, directly involved in study design and analysis, strategic product development planning, and commercialization support. Dr. Stepanians has designed the analyses for the Integrated Summaries of Efficacy and Safety for more than 20 successful marketing applications (NDAs; MAAs) and has presented on behalf of sponsors in meetings with FDA. She has particular expertise in challenging study design and analysis problems, including adaptive design trials, and has participated as a voting or non-voting member of a number of Independent Data Monitoring Committees.

Dr. Stepanians received her Doctor of Philosophy degree in Statistics from Boston University in 1994. She received her Master of Science degree in Mathematics (Statistics) from Massachusetts Institute of Technology in 1984 and her Bachelor of Science degree in Mathematics and Psychology from Boston University in 1982.

"Through collaboration, innovation, and a focus on quality, we help our clients turn groundbreaking ideas into reality and bring life-changing therapies to market."