External Research Program
Overview
This initiative is designed to foster meaningful clinical research by supporting independent, investigator-led studies that explore the use and effectiveness of our biologic products and regenerative therapies. Our goal is to collaborate with healthcare professionals in generating scientific evidence that can improve clinical outcomes and drive innovation in orthobiologics and acute and chronic wound care.
About the program
If you’re a Sponsor-Investigator conducting independent research involving our products, this program may be a fit. If you’re unsure whether your inquiry qualifies under this program or is more suited for a general research grant, feel free to reach out using the contact information below.
Does My Request Qualify?
Is There a Protocol? | Is There a Sponsor-Investigator? | Is It Focused on a Royal Biologics Product or Therapy? | Program |
---|---|---|---|
Yes | Yes | Yes | Eligible for Collaboration Program |
N/A | N/A | N/A | May qualify for General Research Grant |
KEY DEFINITIONS
An institution or organization responsible for the initiation, oversight, and/or funding of a clinical study.
Principal Investigator
The individual who conducts the study at a specific site and ensures scientific and ethical integrity.
Sponsor-Investigator
A single individual who both initiates and conducts the study, assuming full responsibility for its execution and regulatory compliance.
Note: Regulatory responsibilities and terms may vary based on location.
Roles & Responsibilities
- The Sponsor-Investigator is fully accountable for study design, regulatory compliance, IRB approvals, data integrity, and publication efforts.
- Royal Biologics may offer support through product supply, funding, or consultation, but we do not act as the study sponsor and will not influence study design, execution, or outcome reporting.
Investigator-Led vs. Industry-Sponsored Studies
Category | Industry-Sponsored Study | Investigator-Initiated Study |
---|---|---|
Protocol Ownership | Royal Biologics designs and manages the protocol. | Investigator designs and owns the protocol. |
Data Control | Royal Biologics manages and analyzes the data. | Investigator oversees data and grants Royal Biologics access as needed. |
Monitoring | Monitoring conducted by Royal Biologics. | Investigator ensures proper conduct and data quality. |
IP Rights | Typically owned by Royal Biologics. | Rights may remain with the investigator or be shared. |
Deliverables | Determined by Royal Biologics. | Defined collaboratively in research agreement. |
Publications | Authorship and dissemination managed by sponsor. | Investigator determines authorship and publication strategy. |