MedTech
The cost of developing a new medical device or diagnostic has sky-rocketed in the last few years. Bringing a novel medical device through regulatory approval now costs several millions of dollars.
This has been driven by regulatory and reimbursement pressure on bringing devices and diagnostics to market. Both payors and regulators are increasingly expecting real-world evidence to support claims.
Cisiv offers a unique technology to complete your clinical evaluation (CER) and support your pivotal trial to obtain regulatory approval. Types of study we support:
- Pre-market device clinical trial
- PMCF (post-market clinical follow up) study
- RWE study
- Registry under MDR
- PMCF surveys or end user surveys can be a valid method for collecting post-market clinical data
- eCRF for MedTech
- EVA for NICE evaluation
In the UK, NICE launched an Early Value Assessment (Early Value Assessment (EVA) for medtech) which generally requires real-world evidence. Cisiv is a qualified real-world technology partner, should you be interested in an EVA.
Additionally, if your organisation is looking for an analytical partner to apply for an NIHR i4i Programme (NIHR Invention for Innovation), get in touch.
Our technology is suitable for MedTech devices, IVD and radiopharmaceuticals. The platform is compliant with GDPR, ISO27001 and ISO9001 compliant.
Why partner with us?
Cisiv’s platform Baseline Plus, has been designed for the real world environment with incredible ease of use. The design enables data entry from multiple sources; lab users, paper data entry, patients and we can integrate data from a wearable or other monitoring device. The user interface is designed for people who are not experienced in clinical trial conduct. The series of workflows and in-built logic supports a simple and efficient data collection where data quality is embedded at the point of entry. Baseline Plus leverages process automation to reduce the need of expensive and inefficient manual data checking.
Cisiv has experience in supporting RWD as part of the PMCF activities, including observational studies, registries and patient end-user surveys.
To read our case studies click here.
To learn more about how we partner contact us here.
