CALS Corporate Agreements*

After a project or clinical trial has successfully undergone the CALS Expedited Review, a corporate agreement is reached between CALS and the sponsor to move forward with the project or clinical trial. CALS then executes a performance based corporate agreement with the sponsor.

There are 3 basic components to this agreement:

  1. *Project Management Fee:
    A flat rate project management fee to cover the administrative costs incurred throughout the duration of the project or study.
  2. Performance Based Accrual (PBA) Charge: This fee is tied directly to recruitment milestones that are collectively met by the number of active CALS study sites participating in a given clinical trial.
  3. Request for Unrestricted Grant

*[fee schedule is subject to change without notice]

The CALS Network directs revenues generated from Sponsor Agreements to fund the collective academic, research, corporate and administrative objectives of the Network. In return, CALS offers the following value-added services which are of shared benefit to the ALS community and pharmaceutical industry both locally and abroad:

  • expedited review of clinical trials and projects
  • clinical practice guidelines
  • protocol development
  • patient registries and surveys
  • project / clinical trial feasibility assessments
  • site selection
  • centralized negotiations and study budgets
  • fast track communications
  • manuscript / abstract preparation
  • representation on Steering Committees, Advisory Boards
  • regulatory applications / Assignment of Senior Medical Officers (SMOs)

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