Case Study on Clinical Investigation on Vienna Aortic Valve SE System
Geography: N/A
Type Service: N/A
Background/Client Requirement:
A pioneering medical device manufacturing company based in India, established in 2005, has been making significant strides in the healthcare industry and specialized in the development and manufacturing of advanced cardiovascular medical devices. The client had outsourced with Techsol Life Sciences to conduct a Clinical Investigation on the Transcatheter Heart Valves ensuring the regulatory standards (MDR 2017) and compliance.
Project Objective:
The project’s scope is to conduct a clinical investigation on the Vienna Aortic Valve SE System medical device to assess the safety, efficacy, and performance of the device in patients with severe aortic stenosis who were considered as high-risk or ineligible for surgical valve replacement.
The main key objective of the clinical investigation is to apply for a License/Approval for conducting a clinical investigation from the Health Authority (HA). Post approval received from the HA enrolment of patients with severe symptomatic aortic stenosis who met the criteria for TAVR according to current guidelines. Patients were assessed based on the inclusion criteria provided in the protocol/plan.
Techsol Approach:
- Techsol Life Sciences provided support to the client for various activities related to their license Approval, Dossier preparation, Gap analysis of the documentation work, and Query management with the Health Authority.
- Additionally, Site coordination – PI, CRC & team, Clinical Trial Agreements, execution.
- Site Training, Site Compliance, Patient recruitment, Projections, Investigator letters, Site enrolment status report, Clinical monitoring plans, execution.
- Facilitating site audits. Inspections, monthly follow-ups.
- Safety Reporting to Regulatory Agency (Health Authorities/IRB): Medical Monitoring review, AE/SUSARs reporting to IRB/Regulatory authorities.
- TMF setup, document upload, QC review, query management, and resolution & maintenance.
- Also, in recruiting the patients for the Clinical investigation.
Challenges:
- Regulatory Complexity: Navigating intricate regulatory requirements and submission processes poses a significant challenge, potentially leading to delays or rejections in license approval.
- Query Management: Effectively managing and responding to queries from regulatory authorities demands meticulous attention to detail and prompt communication, which can be challenging to maintain.
- Limited Participant Pool: Difficulty in identifying and recruiting a sufficient number of eligible participants within the target population may hinder the study’s progress and impact its validity.
- Participant Retention: Keeping participants engaged and committed throughout the study duration poses a challenge, as factors such as dropout rates and loss to follow-up can compromise data integrity.
- Compliance Burden: Ensuring adherence to regulatory guidelines while maintaining participant-centric practices requires careful balancing and proactive measures to mitigate risks of non-compliance.
- Successfully resolving challenges in regulatory dossier submission and efficient query management led to the approval of the license.
- Implementing strategies such as targeted outreach, patient-centric approaches, and proactive retention tactics enabled effective navigation of obstacles in patient recruitment and retention.
- This proactive approach ensured compliance with regulations while also enhancing participant engagement, contributing significantly to the overall execution of the study.
- The regulatory dossier preparation and submission to the Health Authority and query management support by Techsol helped client.
- Techsol facilitated seamless navigation of Health Authority requirements and the recruitment of CRAs at various sites, enabling manufacturers to feasibly navigate complex requirements.
- The collaboration highlighted the significance of specialized expertise in navigating regulatory challenges, enabling the sponsor to continue providing cutting-edge medical solutions with their Aortic Valve SE System, now approved for a clinical trial in India.
- Collaborating with Techsol allowed the sponsor to smoothly overcome regulatory hurdles to bring innovative products to market, thereby impacting healthcare.