Trial Management and Clinical Operations
Comprehensive Operations Support
Our mission is to deliver effective, end-to-end resource planning, collaboration, and training for our clinical trial partners.
We offer a holistic, well-coordinated, and collaborative approach that leverages our in-depth experience with site, investigator and vendor relationships, creating successful trials that satisfy fast start-up timelines and complicated regulatory environments.
The dedicated Alira Health team acts as an extension of our sponsor’s teams and provides seamless support at every stage of the development process—from study feasibility and site selection to study close-out.
How We Help Clients
Timeline Creation and Analysis
We work with each client to customize the study timeline, shorten if possible, and provide indication-specific expertise to build relationships between the client and potential study sites.
Site Feasibility and Qualification
We work with clients to develop a detailed, indication-focused, site feasibility questionnaire that allows for rapid, reliable site pre-qualification and increases the probability that approved sites will meet accrual expectations.
Site and Investigator Selection
Alira Health has an extensive database of clinical sites active in pharmaceutical and medical device research, as well as long-standing relationships with study coordinators and investigators, providing our clinical trial partners with access to a qualified network of sites and facilitators.
Site Management
As a gateway to study participants, the sites are one of the most valuable assets in a clinical study. Alira Health ensures site staff feel included in all communication and are confident that the Alira Health team is responsive to their needs. This approach guides sites to the best performance possible.
Site Monitoring
With our staff handling site management, our clinical monitors can focus on source data verification. Alira Health stresses indication and protocol training for every CRA, and focuses on team communication in order minimize monitoring variability and keep CRA turnover low.
Additional Clinical Operations Services
- Collection, review, and approval of essential site documents
- IRB/EC submission assistance
- Set up and maintenance of the TMF
- Monitoring of site source data against the CRF/eCRF
- Monitoring of site regulatory documents
- Quality Assurance (QA) audits of clinical trial sites
Why Choose Us for Clinical Trial Management Support?
With Alira Health industry leading CRO as your partner, you will benefit from:
- Exceptional customer service and site relations
- In-depth expertise across the entire clinical trial process
- Flexible and tailored service delivered by multidisciplinary and global teams
- Frequent, transparent, and professional communication
- Guarantee we will lead your study efficiently, safely, and successfully
