Services

LBR provides a myriad of services related to clinical and regulatory contract research—specifically for drug and device development, regulatory strategy and quality assurance services for the global healthcare and life sciences community.

Program Management and Project Management

Program Management Services

  • Client Liaison with Senior Management
  • Overall Program Planning
  • Financial Projections
  • Resource Projections & Management
  • Vendor Management
  • Contract Management
  • Risk Management & Mitigation Strategies
  • Communication Planning across programs and for all contracted services

 

Project Management Services Include:

  • Client Point of Contact
  • Project Planning & Management of individual studies
  • Financial Management
  • Tracking & Reporting
  • Risk Assessment, Management & Resolution
  • Task Ownership Matrix & Team Assignments
  • Communications with project team
  • Point of Issue Escalation & Resolution
  • Staff Training
  • Study Documentation
  • Study Supply Management
  • Site Approval after feasibility & pre-study visit
  • Investigator/Patient Retention Strategies
  • Protocol Deviation Tracking & Management

Site Feasibility Services:

  • Generation of Feasibility Questionnaires
  • Checking FDA Investigator Debarment Lists
  • Generating Potential Site Lists
  • Collation of a site’s IRB Requirements including timelines for submissions (if using a local IRB)
  • Recommendations for Pre-study Site Visit

 

Start-up Services Include:

  • Site Identification & Selection of Investigative Sites
  • Scheduling Pre-study Qualification Visits
  • Preparation and Collection of required Site Regulatory Documents
  • Investigator Contract & Budget Negotiation
  • Review of ICFs & Advertising
  • Central IRB Filings
  • Oversite of Translations (as dictated by study needs)
  • Ongoing Updates to Regulatory Documents
  • Investigator Site Payment

 Services Include:

  • Pre-study Site Visits
  • Site Initiation Visits
  • Interim Monitoring Visits
  • Close-out Site Visits
  • Query Resolution
  • Remote & On-site Visits
  • Query & Discrepancy Resolution
  • Site Training

Contracts with preferred vendors for data management and biometrics are held and managed by LBR to provide clients with a seamless interface. This enables us to function for our clients as one full-service CRO.

In addition, we maintain a preferred vendor list for ancillary services such as IWRS, central laboratory services, central IRB, meeting planning, drug shipping and storage.

As a result of our experience with many Electronic Data Capture (EDC) platforms, we can suggest an EDC platform, or work directly with any EDC provider preferred by the Sponsor.

As regulatory experts, LBR’s regulatory professionals are authorized to represent the Sponsor at meetings with the Food and Drug Administration (FDA).

Services in the development and maintenance of:

  • Trial Master Files
  • Orphan Drug Application Preparation and Submission
  • eCTD Preparation & Conversion for all types of documents
  • Package Insert Development
  • Label Development & Review
  • Advertisement Copy Review

LBR professionals have conducted various types of QA and QC audits.

QA and QC Services include:

  • Routine QA Site Audits
  • For-Cause Site Audits
  • Site Inspection Readiness Audits for FDA/EMA Inspections
  • Vendor Qualification Audits (including IP manufacturing vendors, preclinical providers, clinical laboratories & IP storage/shipment vendors)

Services Include:

  • Safety
  • Medical Writing
  • Veterinary Reproductive Agents
  • Training

Case Study

Rescue Study: Project Management Issues

Client Challenge: The client of a medium-sized CRO reputedly was observing inconsistent monitoring due to a lack of management and oversight.

LBR Solution: LBR was asked by the medium-sized CRO to rescue the study. The company brought the study under control by working with the sponsor…Read More