Clinical Operations
We offer a full spectrum of solutions to support your clinical operation’s needs, from development of clinical strategies, writing clinical protocols, executing clinical trials, conducting PMCF surveys to writing clinical evaluations.
Navigate Clinical Strategy Challenges with Confidence
Navigate Clinical Strategy Challenges with Confidence
Clinical operations are important for medical devices and IVD’s because they ensure that the device is safe, effective, compliant, and usable in real clinical settings. Without strong clinical operations, even a well-designed device can fail to protect patients, meet regulations, or succeed in the market.
Qserve understands in detail the importance of professionally deliver Clinical operations in order to:
- Ensure the device is used safely, correctly, and consistently
- Generate clinical evidence for safety, performance, and effectiveness
- Maintain regulatory and ethical compliance
- Support patient safety and data integrity
- Respect the agreed budget
Qserve CRO provides end-to-end clinical operations support, from study design and site initiation to investigator training and patient recruitment. We oversee device accountability, clinical data collection, and safety reporting, and ensure efficient study close-out with clear, regulatory-ready reporting.
Whether you aim as a MD or IVD manufacturer to gain approval for your devices in the EU, US or other global markets, clinical data generation, appraisal and evaluation is critical to success today. Executing a successful clinical strategy, with the right resources and partners, to achieve regulatory approval in a cost effective manner is a challenge in today’s world.
At Qserve, we provide full scope support for medical device and IVD clinical strategy development, data collection and evaluation, with a practical approach, a focus on quality and compliance, and a very high success rate on approvals. Qserve works in full alignment with:
- ISO 14155 – Clinical investigation of medical devices
- Good Clinical Practice (GCP)
- FDA (21 CFR 812, 820) or EU MDR (Articles 62–82) depending on region
- Ethics committee / IRB approvals
- Data protection laws (HIPAA, GDPR)
Our Functional Areas
Clinical Trials | CRO
We conduct full-scope clinical studies pre- and post-market across a variety of therapeutic areas. As a leading contract research organization, we specialize in providing comprehensive services supporting the successful design, development, execution, and management of clinical trials.
PMCF Surveys
Post-market clinical Follow-Up (PMCF) surveys have become essential for medical device manufacturers in an increasingly regulated medical world. They provide insights into the performance and safety of devices in real-world settings and ensure compliance with regulatory requirements such as the EU MDR and FDA.
IVD Clinical Performance Study
We design and execute IVD clinical performance studies to demonstrate the accuracy, reliability, and clinical value of your diagnostic device. For stand-alone IVD products and for companion diagnostics (CDx) connected to a drug trial. Our team ensures your study generates robust data to support regulatory approval and long-term success.
Clinical Strategy Support
We deliver clinical strategy support to help you define the most effective path from concept to market. Our team partners with you to design innovative, scalable clinical plans that align with regulatory requirements, accelerate timelines, and maximize the value of your clinical data.
Medical Writing
Clear, accurate, and compliant clinical evaluations are essential to get your medical device approved. We specialize in medical writing services that combine scientific precision with regulatory expertise, with a very high success rate in achieving regulatory approval in the EU.
Interim Support
We provide clinical interim support in every aspect of clinical operations during periods of transition or staffing gaps. Whether you need short-term leadership, clinical monitoring, or project coordination, our experts step in quickly to maintain momentum and ensure effective continuation of clinical operations.
Audits & Assessments
We specialize in clinical audits designed for medical device trials. Our tailored services help sponsors maintain control, enhance quality, and prepare confidently for regulatory submissions and inspections.
Clinical Training
We specialize in equipping clinical teams with the skills and insights they need to navigate the complexities of clinical trials while maintaining regulatory compliance.
Let's Strengthen Your Clinical Operations Together
Use clinical expertise to have clear project timelines, effective milestone tracking, and proactive risk management to help avoid delays and cost overruns.
Leveraging the experienced teams of Qserve allows you to streamline communication and ensures better coordination, data quality, and overall trial performance.
Get in touch with us to discuss your clinical needs and find out how Qserve can help you achieve regulatory success efficiently and effectively.
Let's Strengthen Your Clinical Operations Together
Use clinical expertise to have clear project timelines, effective milestone tracking, and proactive risk management to help avoid delays and cost overruns.
Leveraging the experienced teams of Qserve allows you to streamline communication and ensures better coordination, data quality, and overall trial performance.
Get in touch with us to discuss your clinical needs and find out how Qserve can help you achieve regulatory success efficiently and effectively.