Clinical Strategy
The clinical questions originating from the initial clinical evaluation feed into a more detailed clinical strategy. Parts of a clinical strategy involve selecting the patient population, device regulatory status, long-term strategies, formulating endpoints, and statistical justification. This phase of strategy development includes scoping, decision-making, and identification of any (potential) gaps in available clinical data on your device. Qserve CRO is your experienced partner, guiding you through this challenging process. We will always consider the feasibility of operational plans, including budget, timelines, and marketing requirements. We will also support you in defining a plan to collect clinical data on your device in case gaps are identified.
Clinical Evaluation Report
The results of your clinical activities to collect clinical data play a vital role in bridging the clinical gaps and informing your clinical evaluation. A comprehensive clinical evaluation report, backed by robust clinical evidence, forms the cornerstone of your technical documentation. Whether it is for initial market access or ensuring the ongoing performance and safety of your products in the post-market phase, having your own clinical study data provides a reliable safeguard and ensures sufficient clinical data is available.
At Qserve CRO, we take pride in being your experienced and dedicated clinical partner. We are committed to supporting you throughout the entire clinical process, leveraging our expertise to optimize your clinical activities and deliver reliable results.
Post Market Activities
After obtaining initial market authorization, it becomes essential to fulfill the obligation of collecting relevant post-market data, including post-market surveillance (PMS) and post-market clinical follow-up (PMCF) data.
Post-market clinical follow-up surveys have emerged as a popular and cost-effective method for gathering valuable clinical data. These surveys not only help gather sufficient clinical evidence to facilitate the transition from CE-certification under the Medical Device Directive 93/42/EEC to CE-certification under the Medical Device Regulation 2017/745 but have also proven successful in providing real-world data (RWD) to support clinical perspectives for FDA submissions.
Qserve CRO has extensive experience in supporting numerous PMCF surveys and is ready to serve as your dedicated and experienced partner in this endeavor. We possess the expertise and resources to guide you through the PMCF process, ensuring the collection of robust post-market clinical data.
As part of your post market activities, your clinical evaluation report needs to be updated. Qserve can assist you in going this in a practical manner with updates to literature, state-of-the-art and clinical data for your device.
