CLINICAL TRIAL SERVICES
LBRIA delivers high-quality, regulatory-compliant clinical trial management through a focused, hands-on approach designed to ensure consistency, accountability and successful study execution. Our clinical trial managers are assigned to a single study at a time, enabling dedicated oversight and continuity from study start-up through completion.
LBRIA clinical trial managers are fully engaged in all aspects of trial conduct. They work directly with investigational sites to proactively address issues, support compliance, and maintain momentum throughout the study. To ensure timely communication, all calls to LBRIA are answered by a knowledgeable team member, allowing rapid escalation and resolution when needed.
Collaboration and transparency are central to our clinical trial management philosophy. LBRIA maintains open lines of communication with sponsors and does not bill for meetings with our clinical trial managers, enabling frequent interaction and alignment without administrative barriers. This partnership-driven approach supports efficient decision-making and strong sponsor–CRO relationships.
For more than two decades, LBRIA has successfully executed clinical trials that meet regulatory requirements and are accepted by reviewing authorities. Our experience spans a wide range of therapeutic areas and study designs, supported by proven operational processes and regulatory expertise.
LBRIA’s Three-Phase Clinical Trial Management Approach
LBRIA applies a comprehensive, three-phase approach to clinical trial management. Sponsors are supported by the same experienced LBRIA team throughout the lifecycle of the study, ensuring consistency and continuity. Our teams work closely with sponsors, sites, monitors, and vendors to maintain alignment and execution quality at every stage.
PHASE 1:
START-UP
PHASE 2:
STUDY ACTIVE
PHASE 3:
STUDY COMPLETION
PHASE 1: START-UP
Effective planning during start-up is essential to trial success. LBRIA supports sponsors through critical early activities to establish a strong operational foundation, including:
Protocol design support and timeline development,
Source document and subject diary creation,
eCRF design support and UAT testing,
Project plan development,
Site identification and qualification visits,
Vendor identification, contracting, and management,
Site contract and budget negotiations.
PHASE 2: STUDY ACTIVE
DURING the Study Active phase, LBRIA clinical trial managers oversee daily trial operations to ensure compliance with the protocol and regulatory requirements. Activities include:
Site management and protocol adherence oversight,
Site support for subject management and recruitment,
EDC query support and issue resolution,
Patient enrollment tracking,
Investigator payment management,
Investigational product (IP) supply oversight,
Clinical monitoring coordination,
Vendor management,
Trial Master File (TMF) maintenance.
PHASE 3: STUDY COMPLETION
LBRIA manages the Study Completion phase to ensure timely close-out and inspection readiness, including:
Query resolution and source data verification to support database lock,
Site close-out visits,
Quality control of site study binders,
Quality control and finalization of the electronic Trial Master File (eTMF).
