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

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.

    • Assistance with protocol design

    • Identification and Contracting with Principal Investigators, Vendors, and Clinical Sites

    • Regulatory IRB Submissions (local & national)

    • 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

    • Close-out

    • Quality Control (QC) at sites

    • eTMF (electronic Technical Master File)

    • Preparation for FDA audit

Project Management

PROJECT MANAGEMENT

LBR project managers control and manage the study and sites, maintaining excellence across the project.

    • Strategy for each study stage

    • Risk-analysis

    • Financial status reports and evaluations of each study stage

  • 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

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).

    • Clinical Site Audits

    • CSR Audits

    • For-Cause Audits

    • GLP Audits

    • IND, NDA and BLA audits

    • TMF Audits

    • Vendor Qualification Audits

    • Vendor Audits

    • Inspection Readiness

    • Quality management system (QMS) strategy

    • QMS set-up and compliance to ISO 13485

    • Remediation programs

    • Risk management

    • SOP drafting and review

Regulatory Support

REGULATORY SUPPORT

Our regulatory professionals support you with a proven strategic approach, regulatory guidance on submission documents, brochures and submission applications.

    • Gap Analysis of R&D Consulting

    • FDA Authorized Representative for foreign entities

    • Representation with federal / state agencies

    • Regulatory Project Management

    • 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

    • Regulatory Submissions

    • Safety Narratives

    • Protocols (assist Sponsor)

    • CSRs

    • 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

SITE FEASIBILITY

Our expert team are key to establishing a potential site list and qualifying a site for a Pre-Study visit.

    • Feasibility Questionaire

    • Enrollment Opportunities

    • Site Identification

    • Perform remote or on-site visit

    • FDA / Regulatory debarment checks

    • Qualifying Site for a pre-study visit and report

Study Start-up

STUDY START-UP

A tailored study start up and activation plan is a critical to delivering reliable results and improved chance of success.

    • Regulatory document collection

    • Investigator contract and budget negotiation

    • Meet requirements to be able to ship IP

    • Site Protocols

    • Ongoing regulatory document maintenance

    • Investigator site payments

Medical Writing

MEDICAL WRITING

Our medical writers have extensive experience writing for all regulatory documentation and protocols.

    • Preclinical study reports

    • Clinical Study reports (Phase 2-4)

    • Protocols & Amendments

    • Expert reports

    • Investigator's Brochure and updates

    • Product Dossiers

    • Protocols and Amendments

    • Package Inserts and Labels

    • SOPs

Training Services

TRAINING SERVICES

Training is key in keeping your teams up-to-date with study monitoring, training, industry practices and quality control.

    • Project Specific Training

    • Quality Assurance Audit Training

    • IND Training

    • Monitoring Training

    • Health Insurance Portability and Accountability ACT (HIPAA) Training

    • Good Clinical Practices

    • Good Manufacturing Practices

Safety Services

SAFETY SERVICES

We assist you in creating SAE narratives , reports and monitoring in the following areas…

    • Expedited safety reporting to Sponsor

    • Submitting IND Safety reports to IRB

    • Notify Investigators of IND Safety Reports

    • Creating SAE narratives

    • Creating MedWatch forms

    • Expedited safety reporting to Sponsor

    • Medical Monitoring

Data Management and Biostatistics

DATA MANAGEMENT & BIOSTATISTICS

LBR establishes and manages the data management and biometric vendor contracts for a seemless integration.

  • LBR has established relationships with data management for seamless tailored services.

  • 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

SITE CONTRACTS & BUDGETS

LBR expertise in customising contracts delivers a quicker site activation.

    • Contact negotiations

    • Study & Staff Contracts

    • Budget Analysis

    • Tracking and reporting

Clinical Monitoring

CLINICAL MONITORING

From Pre-study to close out, LBRs dedicated team are experts in clinical monitoring.

    • Pre-study Monitoring

    • Initiation

    • Interim

    • Close out

    • 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