The Project Specific Consultation Service includes a complimentary eight-hour consultation. Additional regulatory support beyond the eight hours can be obtained at an hourly rate of $72.00.
What Is a “Project”?
A project is defined as:
- At the preclinical stage (i.e. pre-IND or –IDE), a single investigational entity that may be composed of multiple components (i.e. drug and/or biologic and/or device) which are all required to achieve the desired effect.
- The investigational entity that is identified in a single IND or IDE application.
An eight-hour consultation period is available free of charge for each project, as defined above. At the conclusion of this period of complimentary assistance, additional regulatory support can be continued on a fee-for-service basis, for each individual project.
The DDRS Consultation Service may be utilized for more than one “project”.
Complimentary Consultation
During the complimentary eight-hour initial consultation period, the Research Navigators will begin working with the investigator to identify the most appropriate and efficient path for complying with the regulatory requirements for a given project. This may include helping to arrange discussions with the appropriate regulatory authorities, and if indicated and time permits, may proceed to filing the necessary application(s).
During this complimentary period the Navigators will ensure that they will also:
- Review with investigators and their study teams, all regulatory responsibilities assumed by conducting a clinical study with their investigational entity (i.e. sponsoring an IND or IDE application)
- Provide investigators and their study teams with all the necessary resources and templates for making all required filings and reports.
Regulatory Support on a ‘Fee-For-Service’ Basis
Varying levels of regulatory support, including differing degrees of hands-on involvement by the Research Navigators, are available to investigators at fee-for-service rates. Customized fee-for-service support plans will be created with the investigator’s input to accommodate the specific needs of each project. A Statement of Work with estimates of corresponding charges will be issued to summarize the services that can be expected under each project specific plan.
