Clinical Trials & Clinical Research
For Patients: Advancing Care Together at Mass Eye and Ear
At Mass Eye and Ear, patients are central to our mission to advance medical research. By participating in clinical trials, you play a vital role in discovering groundbreaking treatments and improving care for conditions affecting the eyes, ears, nose, throat, head, and neck.
The Center for Clinical Research Operations (CCRO) at Mass Eye and Ear ensures that all studies are conducted with the utmost care, safety, and ethical oversight. Every clinical trial undergoes rigorous review by the Mass General Brigham Human Research Committee, ensuring the highest patient safety standards.
- World-class care: Receive care from leading specialists dedicated to advancing treatments for vision, hearing, voice, and other conditions.
- Clear and open communication: Learn about the study’s purpose, procedures, and expectations to make informed decisions.
- Personalized support: Our experienced team of research coordinators and clinical specialists is here to guide you, coordinate study visits, and address your concerns throughout the process.
- Multilingual assistance: Our staff speaks multiple languages, ensuring clear communication and support for patients from diverse backgrounds.
- Respect for your time: We work to schedule visits conveniently, ensuring a smooth experience, including billing compliance.
- Commitment to safety: Your rights and confidentiality are our top priorities, with all trials adhering to strict ethical standards.
- Access to cutting-edge treatments: Among the first to benefit from innovative therapies.
- Contribute to medical advances: Help shape the future of medicine by supporting groundbreaking research.
- Expert care: Our team includes more than 20 dedicated professionals, many of whom speak multiple languages, ensuring personalized care and communication for every patient.
Success Stories
Subjects participating in clinical research trials often have many questions before and during their participation.
You can be a part of the next discovery. Almost every treatment, test, drug, or medical device is a result of successful research, dependent on patients like you. Volunteering for research is a way to contribute to knowledge about health and disease. Some research studies pay you for your time.
Visit our Rally with Mass General Brigham website to find clinical research studies that interest you.
- Search active Mass Eye and Ear clinical trials at rally.partners.org or clinicaltrials.gov.
- For non-English speakers, please email us and we will get back to you.
- Contact our team at 617-573-6060 or email us for more details.
For Sponsors: Tailored Support to Meet Your Needs
As a sponsor, the success of your clinical trial relies on a trusted partner who can navigate complexities, maintain rigorous standards, and deliver results efficiently. At the CCRO, we specialize in supporting sponsors by providing a streamlined experience that ensures your goals are achieved while prioritizing compliance and patient safety.
Streamlined Study Start-Up
- Accelerate timelines with expert support for regulatory approvals, site activations, and contract negotiations.
- Benefit from efficient coordination with institutional offices such as Clinical Trials Offices (CTO) and Research Management (RM).
Data-Driven Recruitment Strategies
- Access Mass General Brigham’s extensive patient population, enabling you to precisely meet recruitment goals.Implement tailored recruitment plans that align with study demographics and objectives.
Regulatory and Compliance Excellence
- Full-service support for FDA submissions, including IND and IDE applications.
- Management of Institutional Review Board (IRB) submissions and ongoing compliance.
- Expertise in addressing regulatory challenges, including FDA audits and responses.
Transparent Communication and Reporting
- Stay informed with regular updates, milestone tracking, and robust reporting tools.
- Maintain a clear line of communication with a dedicated CCRO contact, ensuring alignment on every aspect of the study.
Budgeting and Financial Oversight
- Receive support for budget planning, including cost estimation for time and effort in federal and industry trials.
- Accurate milestone tracking and invoicing to ensure financial efficiency and transparency.
- Expedited results: Our team of more than 20 experts minimizes delays and maximizes outcomes.
- Broad access to patients: Leverage one of the most diverse and extensive patient pools in the Mass General Brigham network.
- Multilingual expertise: Our team speaks multiple languages, enabling seamless communication with participants and stakeholders across diverse populations.
- Regulatory confidence: With deep knowledge of regulatory requirements and industry standards, we ensure your study adheres to the highest levels of compliance.
- Customizable collaboration: Whether you’re conducting a large-scale clinical trial or a smaller pilot study, our tailored approach aligns with your unique needs and goals.
For Investigators: Comprehensive Research Support
The CCRO is dedicated to empowering investigators to focus on innovation and discovery. By managing the operational complexities of clinical research, we enable you to dedicate your time and expertise to advancing medical science.
Study Coordination and Oversight
- A dedicated team of more than 20 professionals supports all stages of your study, from initial design to final closeout.
- Assistance with study design and feasibility assessments to ensure successful execution.
- Regulatory management, including IRB and FDA submissions, compliance monitoring, and updating ClinicalTrials.gov records.
Data Management and Analysis
- Secure, accurate, and customized data solutions to maintain the integrity of your research.
- Tools and resources for data collection, management, and analysis that comply with industry standards.
- Experience with database creation and management, including platforms like RedCap and support for data management systems such as Veeva Vault.
Recruitment and Retention Strategies
- Proven methods to efficiently identify, engage, and retain participants to meet enrollment targets.
- Leverage Mass General Brigham’s diverse patient network to maximize study recruitment.
Training and Standardization
- Comprehensive training programs for Study Coordinators and PIs to ensure readiness.
- Develop and implement standard operating procedures (SOPs) and departmental guidelines for consistency and compliance.
Budgeting and Financial Management
- Support for crafting budgets for internal, federal, and industry-funded studies.
- Monitor and address budget deficits to keep studies financially sustainable.
- Assistance with milestone tracking and financial reporting.
Support for Multi-Site Studies
- Seamless coordination of multi-site studies, including clinical operations, data sharing, and communication among study teams.
- Oversight of data integrity, investigational device inventories, and regulatory documentation across all sites.
- World-class expertise: Work with a team of more than 20 professionals experienced in managing studies of all sizes and complexities. At the CCRO, we bring together a team of seasoned professionals with deep experience in clinical research operations. More than 50% of our team has been with the CCRO for 7 years, bringing long-term expertise, deep institutional knowledge, and unwavering stability. Our extensive experience within Mass General Brigham ensures consistent, high-quality support for PIs and their projects, driving research success.
- Collaborative environment: Join a vibrant research community within the Mass General Brigham network, fostering interdisciplinary innovation.
- State-of-the-art resources: Access advanced facilities, technologies, and support services designed to accelerate your research.
- Multilingual assistance: Our diverse team speaks multiple languages, ensuring clear communication and effective support for investigators and their study participants.
- Focus on innovation: By handling the operational details, we free you to concentrate on the science and innovation that drives your study.
For more information, please visit our CCRO resources page on Vitals (log-in required).
