Regulatory RWE Strategy

Our experts have collected and analyzed prospective and retrospective real-world data (RWD) for decades and stay informed on evolving methods and guidelines to provide you with knowledgeable and relevant support and advice. We can help you understand what RWE guidelines mean for your product and help you develop a robust approach to utilizing real-world data for every stage of your drug or device development journey.

Incorporating Real-World Evidence Into Your Product Development
The RTI team have been fantastic to work with. Every part of our collaboration process has been very smooth and is a credit to RTI. Our group is looking forward to continuing working with RTI on this project and hopefully other projects in the future. Thank you!
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Services

Our diverse background in clinical research, regulatory submissions, epidemiology studies, and drug, vaccine, and medical technology safety and effectiveness enables us to align the right approach with your objectives. Based on your needs, we can provide consulting support for specific projects or can set up long-term arrangements that allow access to specific experts on an ongoing basis.

Post-Authorization Studies

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Strengthen safety, validate efficacy, and fulfill regulatory obligations with post-authorization studies that help you sustain market success

Feasibility Assessment

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Estimate cost and timeline requirements, assess institutional review board (IRB) needs, and determine eligibility criteria, patient availability, site capacity, and data source reliability

Protocol Development

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Ensure rigorous scientific validity, seamless regulatory alignment, and operational efficiency from day one

Best Practices for Adopting AMCP Format Version 5.0
Webinar Content
In this 45-minute webinar, our experts will walk you through the updated sections to highlight the changes and provide you with best practices for developing or updating your next AMCP dossier.
FORTEO® Post-Market Osteosarcoma Surveillance Program: Real-World Data Contributes to Label Change
Update
Due to the strength of the findings, the drug sponsor was able to end their post-market commitment five years ahead of schedule
RTI-HS Leads Consortium Working on EMA-funded Project to Aid Real-World Data Use
Update
EMA has recently launched the MINERVA project aimed at strengthening the use of real-world data in medicines development. RTI Health Solutions researchers will coordinate the project.
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Dec 14 - 17, '25
18th Annual Conference on the Science of Dissemination and Implementation in Health

RTI will be attending the 18th Annual Conference on the Science of Dissemination and Implementation in Health. Message our team below to set up an on-site meeting.
 

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Feb 11 - 13, '26
ACCESS Forum US

As a Charter sponsor, RTI Health Solutions is excited to return to ACCESS Forum in 2026. Our team will be presenting and is available for meetings on-site. We hope to see you in New Orleans.

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Mar 2 - 4, '26
DIA Medical Affairs and Scientific Communications Forum

We're excited to sponsor this year's DIA Medical Affairs and Scientific Communications Forum. 
 

Amsterdam canal with boat, brick bridge, and traditional houses
Mar 3 - 4, '26
World EPA Congress

As a Silver sponsor, RTI Health Solutions is excited to return to the World EPA Congress in 2026. Our team will be presenting at 1pm on 3 March and is available for meetings at booth 413. We hope to see you in Amsterdam.

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Mar 22 - 24, '26
MAPS Americas 2026

RTI Health Solutions is excited to return to MAPS Americas in 2026. Visit our booth #158 on the fourth floor to speak with our team. We hope to see you in Denver.