| Team | Description | Fax# | Email |
|
Project Management Team
|
Serves as the primary point of contact for sponsors and CROs to answer study-related questions and provide general guidance while a study is under Schulman oversight.
|
513-761-1460
|
|
|
Submission Team
|
Prepares new protocols and additional site submission documents for Board review.
|
866-596-1535
|
|
|
Approval Team
|
Prepares initial protocol approval documents and processes requests for site enrollment of family member or employee (Non-Coercion Addendum).
|
877-304-9298
|
|
|
Business Development
|
Performs all sales and marketing functions and assists with new business proposals.
|
513-761-1460
|
|
|
Translation Team
|
Processes all requests for translation of study related documents (Informed Consent Documents, Study Related Materials, and Recruitment Materials).
|
877-850-2462
|
|
|
IRB Coordinators
|
Facilitate the Board review process by working with the Board, sponsors, CROs/SMOs, sites and multiple Schulman teams; and assist in addressing subject complaints.
|
877-304-9289
|
|
|
Accounting Team
|
Generates invoices, applies payments, manages collections, and Accounts Payable.
|
513-794-5741
|
|
|
Document Management Team
|
Sends Study Status Report reminders; logs in received Study Status Reports; fills copy requests; handles and maintains all study files and documentation.
|
866-657-7917
|
|
|
Amendments Team
|
Processes protocol amendments, Administrative changes to protocols, request for revised informed consent documents, and revised FDA Form 1572 submissions.
|
866-657-7914
|
|
|
Product Safety Team
|
Processes safety reports, Serious Adverse Event reports, revised Investigator Brochures, Data Safety Monitoring Committee summary reports and Annual Device Status Reports.
|
866-657-7915
|
|
|
Recruitment Team
|
Processes recruitment and study related materials.
|
866-657-7916
|
|
|
Indemnity, Confidentiality, and IRB Services Agreements
|
Processes indemnity, confidentiality and IRB services agreements.
|
513-794-1239
|
|
|
Regulatory Affairs
|
Processes reports related to study maintenance, such as Study Status Reports, exemptions, and unanticipated event reports.
|
513-761-1154
|
|
|
Compliance
|
Processes deviations from protocol and Board requirements. Investigates issues of non-compliance, and manages site visits for the Board.
|
513-761-1154
|
|
|
Quality Improvement
|
Facilitates the Quality Improvement Program which includes the collection and analysis of data as well as the initiation of QI activities to continually improve processes and exceed the expectations of our clients.
|
513-761-1154
|
|
|
Technical Support
|
Provides website and portal support for clients.
|
513-761-1460
|
|