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  Project Strategy and Development

Our experts in global drug development work together with your management team to apply collective knowledge and execute winning strategies, with particular expertise in cardiovascular disease, lipids, and atherosclerosis. We bring proven clinical development principles and management practices which will yield robust clinical data and the ability to meet your aggressive timelines.

Strategic Consultancy
  • Working with your management team, we evaluate intelligence, regulatory requirements, and your target objective.

  • By using a strategy design process and planning workshops we help management teams identify clear and effective drug development strategies and create a successful Clinical Development Plan.

  • From initiation to completion, we will identify major issues and risks, manage expectations and outcomes, and deliver the best results.

Project Execution

  • Clinical Lynx has extensive experience in initiating, managing and completing clinical trials.

  • We will work directly with your team, or contracted organizations to implement your strategy and meet aggressive timelines.

Collaboration with Therapeutic Experts

  • Clinical Lynx can help you establish and maintain strong relationships with therapeutic experts. We will identify potential opinion leaders to participate in Steering Committees and Advisory Boards and work with your team to develop and maintain collaborative relationships.

  • We can organize and facilitate data reviews in conjunction with Steering Committees and Data Safety Monitoring Boards. We will identify experienced chairpersons and committee members and develop procedures for committee conduct.

Clinical Trial Design

  • We will target and accelerate optimal trial design, identify appropriate endpoints and advantageous statistical approaches, evaluate study costs, marketing needs and regulatory requirements, and obtain opinion leader input.

  • Clinical Lynx has extensive experience in evaluating emerging technologies and potential biomarkers, and have developed systematic methodologies for applying these technologies to clinical trial design.

 

 

Copyright © 2007 Clinical Lynx Inc.
Last updated: July 1, 2007