CLINICAL TRIAL SERVICES
LBR Regulatory has a unique approach to clinical trial management, designed to deliver a high quality, regulatory-compliant study. LBR clinical trial managers are only assigned to one study at a time. This approach ensures consistent oversight every step of the way.
Our clinical trial managers don't just sit on the sidelines; they're fully immersed in every facet of the trial, engaging directly with sites to swiftly address any concerns. At LBR, our managers are the frontline responders, ensuring rapid resolutions. To enhance our response time, all calls to LBR are answered by a team member.
But it's not just about responsiveness – it's about fostering seamless collaboration between Sponsors and CROs. At LBR, we believe in open lines of communication. That's why we don't bill Sponsors for meetings with our clinical trial managers. They're ready to support your study with as many meetings as necessary.
For over two decades, LBR has been committed to executing clinical trials that meet regulatory requirements and are accepted by the reviewing agency.
LBR applies a comprehensive 3-phase approach to Clinical Trial Management. During this process you will have the same experienced LBR team from start to finish. LBR’s clinical trial management teams work directly with our sponsors, sites, vendors, and monitors to ensure consistency during the project.
PHASE 1:
START-UP
PHASE 2:
STUDY ACTIVE
PHASE 3:
STUDY COMPLETION
Start-Up Phase
Proper planning at the start is essential for a successful Clinical Trial. Protocol design, identifying principal investigators and sites, negotiating site contracts, contracting vendors and setting milestones are important to ensure success. Start-up phase activities include:
Assist with protocol design/timelines
Create source including subject diaries
Assist Sponsor with eCRF design and UAT testing
Create project plans
Identify, contract, and/or manage study vendors
Identify sites
Conduct qualification visits
Contract and budget negotiations
Study Active Phase
Our Clinical Trial Managers will actively manage the Study Active phase ensuring the Clinical Trial runs effectively and in accordance with the protocol and regulatory requirements. Study active phase activities include:
Ensuring clinical sites are executing the protocol
Assisting sites with subject management
Assisting sites with queries in the EDC
Assisting sites with patient recruitment
Patient enrollment and tracking
Investigator payment management
Investigational product (IP) supply management
Clinical monitoring
Vendor management
Maintain and update Trial Master File
Study Completion Phase
Our Clinical Trial Managers will oversee the Study Completion phase, ensuring timely database lock, site close-out visits, and a full QC of the eTMF. Study completion activities include:
Query resolution and SDV of EDC for database lock
Site close-out visits
QC of site study binder
QC of study eTMF