Challenge:
A small company specializing in an innovative robotic platform technology for precision surgery in oncology approached AlvaMed for CRO support. The client’s goals were to develop a clinical strategy and a study protocol with support documents (consent, Case Report Forms (CRFs), regulatory documentation) aligned with that strategy. Additionally, they wanted to have a study-ready site with a Clinical Trial Agreement (CTA) and budget negotiated, and with an approved study protocol that they would be trained to, in order to embark upon enrollment.
As many small companies do, they had a fixed budget for the design, execution and implementation of this strategy. They trusted AlvaMed’s proven track record of executing projects on time and within budget and our deep understanding of clinical strategy from early concept through approval.
Approach:
AlvaMed implemented the following approach:
- Clinical Strategy Development: AlvaMed took a deep dive into the client’s technology, assessed the competitive landscape and the regulatory pathways and clinical data support that their competitors had used to gain 510(k) approval. Next AlvaMed worked with the client to create and design an approach to minimize the lead time for clinical study enrollment by leveraging the technologies mode of operation and risk profile.
- Protocol and Clinical Document Design/Development: In parallel with the strategic initiatives, AlvaMed began work on the clinical protocol design as well as development of all ancillary clinical study materials to ensure a successful study. Informed consent, CRFs, associated guidelines and source documents were created, as well as all regulatory support documents. Additionally, the client lacked the procedural infrastructure needed for successful compliant study execution, so AlvaMed incorporated an entire suite of clinical SOPs into the client’s quality system, tailored to the client’s particular needs.
- Site Start Up: The client already had engaged their top KOL as the lead site, but relied on AlvaMed to then execute site level contracting, budget agreement and initiation. Drawing from our library of templates and extensive expertise in negotiating and finalizing these types of agreements, we were able to quickly obtain a signature ready CTA/budget.
- IRB Approval: As mentioned above, a substantial part of the strategic plan was to minimize lead-times for clinical study commencement. To that end, AlvaMed drafted a risk assessment document which was submitted in conjunction with the clinical protocol and consent with the goals of obtaining a Non-Significant Risk designation from a central IRB. This approach would allow for a study start up that would obviate the need for an IDE submission to the FDA ahead of proceeding.
Results:
AlvaMed delivered the following:
- Strategic Plan for Clinical Study: Optimized the client’s clinical strategy to create a compliant design that would maximize efficiencies and streamline the approach for gaining study approval.
- Compliant, Submission and Execution Ready Documentation: Provided full submission ready clinical protocol along with associated clinical and regulatory documentation within 6-weeks of project initiation.
- Clinical Trial Agreement and Budget Finalization: Negotiated both contract and study budget on behalf of client, obtaining a fully executed agreement between site and client in less than 2 months.
- IRB Approval and Site Training: In parallel with negotiating the CTA, we were able to submit and obtain full IRB approval, crucially, with Non-Significant Risk designation, which saved the clients valuable time and effort and allowed them to proceed with the study, without having to go through the long and arduous process of obtaining an IDE. Subsequent to obtaining both the IRB Approval and NSR designation, successfully trained site (SIV) and kicked off study.
Impact:
This case study demonstrates the tangible impact AlvaMed can have on clients navigating complex strategic pathways. By providing expert guidance, efficient tools, and unwavering support, we help clients achieve their goals, minimize their timelines and ultimately, improve patient outcomes.
Takeaways:
- Reduced burden and risk: Streamlined submission process, saving the client valuable time and resources.
- Enhanced compliance: Implemented SOPs to meet the compliance standards, minimizing the risk of non-compliance issues at future audits.
- Efficient documentation: Leveraged AlvaMed’s in-house templates and expertise to expedite documentation updates, reducing costs and delays.
- Successful Study Launch: Under a highly compressed time-line, delivered IRB approval at a study-ready site, allowing for an expedited study launch.
