A Strategic Approach To Clinical Trials

We can manage your entire clinical program or any part of it. You decide what best fits your product, team and company.

Working with you to achieve your business objectives

Global Clinical Planning

Lincé Consulting takes a strategic approach to clinical planning and integrates regulatory, quality, reimbursement and marketing requirements into the clinical plan upfront.  We can assist you with any size study including small pilot and first-in-human trials to larger-scale pivotal trials involving sophisticated designs and long-term follow-up across clinical settings and geographies.

Lincé Consulting will work with you to ensure that the clinical trial design will help you achieve your business objectives – whether those are short or long-term in nature. We offer comprehensive management solutions for your clinical program, whether you need assistance with the entire process or specific components. You decide what best fits your product, team and company.

Global Clinical Services

  • Trial Development and Initiation in Accordance with Strategic Objectives
  • Trial Management
  • Trial Documentation Preparations Protocol, informed consent form, case report forms, source documentation worksheets, investigator brochure, questionnaires, recruitment materials
  • Government Applications
  • IRB/EC Applications
  • Clinical Site Identification/Qualification
  • Clinical Trial Agreements & Budgets
  • Clinical Site Initiation
  • Clinical Compliance Standard Operating Procedures (SOPs) and Forms
  • Local Sponsor Identification/Qualification
  • Local Sponsor Management
  • Clinical Event Committee/Data Safety Board Identification, Set-up and Management
  • Core Laboratory Identification and Coordination
  • Medical Monitor Identification and Management
  • Trial Monitoring to Ensure Compliance with IDE/IND, GCP, ICH, ISO and Other International Regulations
  • Investigator Meetings
  • Data Management
  • Data Acquisition/Analysis and Presentation for Submissions and Publications
  • Biostatistics
  • Medical Writing
  • Manage and Maintain Trial Master File
  • Adverse Event Monitoring and Reporting
  • Investigational Site Payment Tracking and Invoice Generation
  • Trial Registration and Maintenance
  • Progress and Final Reports
  • Study Close Out
  • Regulatory Audit Preparation and Support
Our Services
  • Regulatory
  • Clinical
  • Quality
  • Project Engineering

Ready to Get Started?