Planning and executing an ethical, feasible, and efficient clinical trial can be overwhelming, especially when incorporating real-world evidence and decentralized methods.
With the advancement of data and digital health technologies also come new ways to interact with patients in clinical trials, further complicating trial design plans.
Supported by decades of clinical operations and IRB experience, Univo IRB’s clinical study design consulting services help researchers navigate new trial models to conduct high-quality and cost-effective trials that generate reliable and actionable evidence and, most importantly, improve the patient experience.
Customized and Comprehensive Consulting
Univo IRB’s clinical study design consulting is tailored to the specific needs and objectives of your trial, no matter the discipline, therapeutic area, region, or setting.
Our services include:
- Developing study protocols and informed consent forms
- Implementing generic prescreening protocols
- Evaluating the feasibility and validity of the study endpoints and outcomes
- Incorporating the voice of the patient in the design
- Exploring how real-world evidence can support study designs and objectives
- Ensuring compliance with good clinical practice (GCP) during study development
- Considering alternative trial designs that go direct to the patient
- Identifying and mitigating potential risks and biases in the study design
- Applying for ethical approval from the IRB
- Implementing decentralized study procedures, such as remote monitoring, electronic data capture, and telemedicine
- Determining appropriate patient recruitment campaigns and practices
- Providing ongoing consultation and guidance throughout the study life cycle
Are you ready to plan and execute a trial that meets study objectives, is compliant with regulatory standards, and incorporates the voice of the patient?
