Post-Market Surveillance for Clinical Trials

Comprehensive Post-Market Surveillance for Product Safety.

ADBC CRO offers post-market surveillance services to monitor the safety and performance of medical devices and pharmaceuticals after approval. We ensure regulatory compliance, identify potential risks, and protect patients, supporting ongoing product safety and success.

It is the post-market surveillance in the life cycle of medical products. Once a product has entered the market, its safety, efficacy, and performance must be monitored. ADBC CRO offers all the post-market surveillance services specifically tailored to medical devices, drugs, and biologics. Our experienced team assists manufacturers in maintaining compliance with regulatory authorities while gathering critical data for ongoing product improvements, risk management, and future regulatory submissions.

What Sets ADBC CRO Apart in Post-Market Surveillance

  • Proactive Risk Identification and Mitigation
    We, at ADBC CRO, focus on the identification of potential risks in the post-market phase. We ensure that corrective action can be taken promptly, so we don't allow the risks associated with your product to jeopardize patient safety or its market performance.
  • Tailored Post-Market Strategies
    Each product is unique; therefore, we provide a customized post-market surveillance strategy. Be it real-time monitoring or periodic review; our services are designed based on the specific needs of your product and market condition.
  • Ease of Integration into Your Quality Systems
    Our experts will collaborate closely with your in-house teams and integrate post-market surveillance activities with your existing quality management systems for continuous compliance and operational efficiency.
  • Regulatory Competence for Market Growth
    As part of our post-market surveillance management, we help in expanding your product's market reach, ensuring that all surveillance activities align with the multiple regional requirements of Asia-Pacific, LATAM, and the Middle East.
  • Continuous Product Development
    We base improvement of our products using data acquired post-market surveillance so your product will continue to adapt with the changing needs of health care providers and their patients, and stays on the competitive edge.

Our post-market surveillance services include the following

Adverse Event Reporting We monitor and report adverse events related to your product, ensuring that any negative reactions or complications are promptly identified, analyzed, and reported in compliance with regulatory requirements.
Product Performance Monitoring Ongoing tracking of product performance in the market, evaluating how the product functions under real-world conditions, and identifying any areas for improvement or additional testing.
Risk Management and Mitigation Identification of potential risks associated with the product, including conducting risk assessments and developing strategies to mitigate any identified issues, ensuring continuous patient safety.
Regulatory Reporting and Compliance We help in post-market surveillance regulatory submissions to ensure compliance with the reporting and monitoring requirements of FDA, EMA, and other global regulatory bodies.
Market Feedback Collection and Analysis Collection and analysis of feedback from healthcare professionals, patients, and other stakeholders to assess the overall satisfaction and performance of the product.
Clinical Data Collection for Ongoing Safety Assessment Continuous collection of post-market clinical data, where the potential safety concerns would be monitored and the clinical benefits for the product continue to be monitored as well.
Recall Management and Corrective Actions When needed, we manage the recalls of the product with necessary corrective actions based on findings from surveillance, ensuring the product is either modified or removed from the market as needed.
Post-Approval Studies and Trials We help with the planning, implementation, and oversight of post-market studies, so that your product remains safe and effective long after its market launch and meets all the regulatory and market needs to maintain approval.

Join ADBC CRO to ensure post-market safety, efficacy, compliance!

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Global Impact

Our mission extends beyond delivering products and services; we are dedicated to making a lasting positive impact across the globe. Through our commitment to excellence in customer service, product innovation, and regulatory compliance, we drive sustainable growth, foster trust, and set new standards within our industry. Each initiative is part of our vision to empower communities, support industries, and contribute meaningfully to a better world.

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