STAND ALONE SERVICES:
We provide the following as part of our Management Services, or as stand-alone assistance.
SITE FEASIBILITY
Our expert team are key to establishing a potential site list and qualifying potential sites for a clinical trial.
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Feasibility Questionaire
Enrollment Potential
Site Identification
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Perform remote or on-site visit
FDA / Regulatory debarment checks
Pre-Study Visit Report
STUDY START-UP
LBR can handle all pieces of the start-up process for any clinical trial.
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Central IRB Approval
Develop Study Source Documents
Create Site Study Binders
Identify and Contract Study Vendors
Develop Study Plans
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Site IRB Submission
Collect and QC Site Regulatory Documents
Investigator Contract and Budget Negotiation
Conduct Site Initiation Visits
SAFETY SERVICES
We assist you in writing SAE narratives, safety reports, and provide medical monitoring.
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Expedited Safety reporting to Sponsor
Submitting IND Safety Reports to IRB
Notify Investigators of IND Safety Reports
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Creating SAE narratives
Creating MedWatch forms
Medical Monitoring
DATA MANAGEMENT & BIOSTATISTICS
LBR can recommend quality Data Management vendors and manage them for you.
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LBR has established relationships with data management vendors for a seamless service.
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Complex data in modern healthcare data ecosystems require comprehensive biostatistics and statistical programming services solutions.
Our colleagues from Innovative Analytics offer expert data management, statistical analysis, and smart customized data applications and programs from study start to finish. Experienced data scientists and statisticians offer technical support for complex trials, working closely with clinical data and project management, using advanced tools, AI, automatic data mapping, and statistical applications.
Quality Control services and collaboration guarantee the efficiency and accuracy of your study; reducing cycle times and increasing the usability of clinical trial study, and real word data.
SITE CONTRACTS & BUDGETS
LBR can streamline the site contracting and budget process for clinical trials.
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Draft Clinical Trial Agreements
Negotiate Clinical Trial Agremeents with Sites
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Develop Study Specific Budget Templates
Negotiate Study Budgets wth Sites
CLINICAL MONITORING
From Pre-Study Visits to Close-out Visits, LBR CRAs are experts in clinical monitoring.
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Pre-Study Visit
Site Initiation Visit
Interim Monitoring Visit
Close-out Visit
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QC Monitoring Visits for Oversight
Inspection Readiness Visits for FDA Audit Preparation