At NEOX we understand the changing paradigm in drug and medical device development. We understand the methodological strengths and weaknesses of randomly controlled trials (RCTs), fully appreciate the drivers for the inclusion of Real World Data/Real World Evidence (RWD/RWE), and understand when and where RWD and RWE are needed. We also closely follow shifts in regulatory environment, such as those represented by recent FDA´s RWE program and EU´s planned extended cooperation between HTAs.
Our methodology combines clinical, pharmacological, epidemiological and statistical knowledge. Our experienced in-house legal staff is at your disposal to guide you through the legal context of your project. On top of that, we have full understanding the legality around RWD/RWE. Our approach ensures:
If you choose NEOX for your RWD-RWE needs, we will make sure that you receive:
NEOX has extensive experience in majority of the formats used in RWX, including observational studies, patient registries, patient surveys and patient reported outcomes, and pragmatic trials. Our solutions-based approach drives our statisticians to integrate RWD/RWE into NEOX’s data management services.
NEOX is versed in designing, conducting and managing several types of Patient Support Programs. We understand the important role that patient compliance and adherence impact on the success your product. Our experienced pharmacists, nurses, and project coordinators engage with patients through productive and meaningful dialogue, supporting the patient´s adherence and compliance.Our services include:
Our project teams are supported by experienced inhouse legal staff to provide guidance and risk management on: