OUR SERVICES
We provide comprehensive CRO services to support your product development preclinical and clinical studies, from concept through approval for US drug and medical device market licensing applications.
As stand-alone solutions, or part of a complete development package, our specialist teams can deliver a full range of services for a wide variety of study types specific to your requirements.
We have experienced teams of professionals that will guide you in the service or development package you require.
DEVELOPMENT PACKAGES
We provide the following development packages as part of our management services.
CLINICAL TRIAL MANAGEMENT
The most comprehensive service encompassing the full development package from our specialist teams to guide you on your product licensing approval journey. We apply a comprehensive 3-phase approach to Clinical Trial Management.
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Assistance with protocol design
Identification and Contracting with Principal Investigators, Vendors, and Clinical Sites
Regulatory IRB Submissions (local & national)
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Study Conduct
Clinical Site Implementation: Start-up, and ongoing regulatory management
Patient enrollment and tracking
Clinical trial payments management
Manage Investigational Product (IP) supplies
Clinical Monitoring
Vendor Management (fulfilment houses, clinical supplies, data management, laboratory interfaces, etc,)
Maintain and finalize Trial Master File
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Close-out
Quality Control (QC) at sites
eTMF (electronic Technical Master File)
Preparation for FDA audit
PROJECT MANAGEMENT
LBR project managers control and manage the study and sites, maintaining excellence across the project.
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Strategy for each study stage
Risk-analysis
Financial status reports and evaluations of each study stage
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Streamline the study start-up through to-completion process from clinical trial site efficiency, increased performance, and quality improvement, including:
• Optimizing protocol design, and management
• Site / Investigator identification
• Study start up materials and training
• IRB assistance
• Budget and Contracts reviewed and/or negotiated
• Research billing
• Protocol execution
• Ongoing support in relation to: supplies logistics, labeling, central randomization, study monitoring, eTMF documentation and weekly reporting.
QUALITY ASSURANCE (QA)
Our independent audit personnel assesses the quality control processes in accordance with protocol, standard operating procedures (SOPs) and Good Clinical Practices (GCP).
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Clinical Site Audits
CSR Audits
For-Cause Audits
GLP Audits
IND, NDA and BLA audits
TMF Audits
Vendor Qualification Audits
Vendor Audits
Inspection Readiness
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Quality management system (QMS) strategy
QMS set-up and compliance to ISO 13485
Remediation programs
Risk management
SOP drafting and review
REGULATORY SUPPORT
Our regulatory professionals support you with a proven strategic approach, regulatory guidance on submission documents, brochures and submission applications.
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Gap Analysis of R&D Consulting
FDA Authorized Representative for foreign entities
Representation with federal / state agencies
Regulatory Project Management
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Pre-IND Briefing Documents
INDs
White Papers
Annual Reports (INDs, NDAs, DSURs, etc)
FDA Meeting Requests and Support
Orphan Drug Applications
Rare Disease Applications
Fast Track and Breakthrough Designations
NDA, BLA, NADA
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Regulatory Submissions
Safety Narratives
Protocols (assist Sponsor)
CSRs
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Review of clients’ regulatory submission documents
eCTD Submission preparation
QC Regulatory Submissions
STAND ALONE SERVICES:
We provide the following as part of our Management Services, or as bespoke stand-alone assistance.
SITE FEASIBILITY
Our expert team are key to establishing a potential site list and qualifying a site for a Pre-Study visit.
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Feasibility Questionaire
Enrollment Opportunities
Site Identification
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Perform remote or on-site visit
FDA / Regulatory debarment checks
Qualifying Site for a pre-study visit and report
STUDY START-UP
A tailored study start up and activation plan is a critical to delivering reliable results and improved chance of success.
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Regulatorydocument collection
Investigator contract and budget negotiation
Meet requirements to be able to ship IP
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Site Protocols
Ongoing regulatory document maintenance
Investigator site payments
MEDICAL WRITING
Our medical writers have extensive experience writing for all regulatory documentation and protocols.
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Preclinical study reports
Clinical Study reports (Phase 2-4)
Protocols & Amendments
Expert reports
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Investigator's Brochure and updates
Product Dossiers
Protocols and Amendments
Package Inserts and Labels
SOPs
TRAINING SERVICES
Training is key in keeping your teams up-to-date with study monitoring, training, industry practices and quality control.
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Project Specific Training
Quality Assurance Audit Training
IND Training
Monitoring Training
Health Insurance Portability and Accountability ACT (HIPAA) Training
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Good Clinical Practices
Good Manufacturing Practices
SAFETY SERVICES
We assist you in creating SAE narratives , reports and monitoring in the following areas…
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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
Expedited safety reporting to Sponsor
Medical Monitoring
DATA MANAGEMENT & BIOSTATISTICS
LBR establishes and manages the data management and biometric vendor contracts for a seemless integration.
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LBR has established relationships with data management for seamless tailored services.
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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 expertise in customising contracts delivers a quicker site activation.
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Contact negotiations
Study & Staff Contracts
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Budget Analysis
Tracking and reporting
CLINICAL MONITORING
From Pre-study to close out, LBRs dedicated team are experts in clinical monitoring.
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Pre-study Monitoring
Initiation
Interim
Close out
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Remote and on-site visits
Query and discrepancy resolution
Site training
Motivational visits
WE HAVE OVER 25 YEARS OF EXPERIENCE, KNOWLEDGE AND EXPERTISE IN REGULATORY & CLINICAL CONSULTING
AREAS OF EXPERTISE
We have addressed the needs of many clients at various stages of development across a wide area of therapeutic expertise including:
Antimicrobial / Anti-Infectives
Cannabinoid Addiction
Cancer Therapeutics
Diabetes & Endocrine Disorders
Femtech & Women’s Health
Pediatric
Infectious Diseases, Vaccines and Phages
Neurosurgery
Osteoarthritis
Rare Diseases
Ulcerative Colitis
Veterinary