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Mega Trials

Schulman’s Board expertise, streamlined technology and operational capacity give sponsors and CROs a unique advantage in managing mega-studies.

Schulman currently oversees at least twenty individual research protocols involving 150 or more central IRB sites and several dozen research programs involving 250+ sites.

For more information on Schulman’s services for mega-trials, please contact
Business Development or request our Mega-Trials Case Study.

Extensive Experience in Practically Every Therapeutic Area

The Board’s network of consultants is also available for particularly unique or complex projects.

Rapid Communication of Review Activities and Approvals

Our internal database seamlessly integrates with our WebPortal 3D and SiteAccess systems, providing clients with review status updates and documents for download as soon as the information is available.

Identify Priority Sites

Our team will work with you to identify the key sites whose review must be prioritized to ensure approval documents for those sites are posted promptly and according to your timelines.

Primary Point of Contact throughout the Life of the Study

Your Study Manager works with Schulman’s operational staff to ensure that materials are processed efficiently and that your study’s important milestones are met.

Study Start-Up Call

Prior to your new study submission, your Study Manager will coordinate a teleconference to discuss timelines, unique study requirements and other important information.

Progress Reporting to Ensure Key Milestones Are Met

Your Study Manager will work with your study team to establish regular meetings and metrics reporting.

Streamlined Technology Simplifies the Way Sponsors and CROs Manage Large Numbers of Sites

Our SmartForms allow users to distribute a standardized submission form template to all sites, and the reporting features in WebPortal 3D make it easy to quickly monitor review status information.

Operational Capacity and Flexible Resources

Schulman’s operational teams are comprised of dedicated subject matter experts, making them highly efficient at processing large quantities of new submissions quickly and accurately. Team members are also cross-trained, which allows for resource flexibility in accommodating large trials.

Customized Services for Institutions

Schulman has worked with more than 2,000 hospitals, academic centers and research institutions. Our approach ensures that these sites are reviewed efficiently, with each institution’s unique requirements appropriately addressed and managed. Read more about Schulman’s services for institutions or request our Institutional Services Case Study.

International Review Consideration

For global mega-trials, Schulman’s Board can provide a review summary for consideration by ethics panels at sites outside the US and Canada.*

*While regulations do not allow Schulman to provide full IRB oversight for these international sites, many international ethics boards prefer to include a US IRB’s perspective in their own ethical review deliberations.