Utilising CRFWEB for post-market investigations – PMS – PMCF

The New MDR Regulations Have Changed The Industry

Learn more on post-market regulation here

Post-market investigtions. New regulations mean medical device businesses need to continually demonstrate their product is fit for purpose. You have to consider:

What form of data you need to collect, analyse and present to meet MDR requirements
Will you need to undertake any post-market investigations?
The reality and practicality of finding new sources of data whilst maintaining GDPR compliance
The potential of new research protocols and technologies to capture continuous data
Requirements to set acceptability criteria with warnings/alarms for subjects and study staff
Planning and scheduling to report on all of this information on a regular basis

Many EDC systems are just not capable of handling the different dynamic this creates for data capture… CRFWEB is.

Learning more on post-market investigations – regulatory impact

It’s important to have a thorough understanding of the post-market MDR regulations and their global impact. Our info sheets and articles will get you up to speed in no time at all. Below you will find links to 2 useful overview pages and you can access all info sheets and articles by visiting the Medical Device Resource Centre.

Info Sheet – Medical Device Clinical Studies explained
What protocol options are available for Medical Device Studies? How are they supported by technology and what are the design considerations?
Info Sheet – Post-market Studies
A guide to the requirements of Post-Market Clinical Follow-up studies as part of Post-Market Surveillance studies under EU MDR.

With a smart, modern user-interface, enabling clear and simple data entry yet sophisticated study design build, CRFWEB delivers on all the key requirements of a compliant, audit-trailed eClinical system with all the features required for regulated medical device investigations.

Click here to learn more on our technologies for medical device trials

Our Services

We’re experts in the delivery of solutions for medical device sponsors and CROs and we recognise that there is no one-size-fits-all appoach in this industry. Our flexible system is perfectly suited for medical device investigations, but if you have a specific need that lies outside the norm, talk to us. We can undertake client-specific development if required. Whatever your requirements, we’ll assist you every step of the way.

Expert support if you wish to build your own studies
Or we’ll build the study for you from your approved documentation
Training for your team and your sites on request

5 Star Reviewed

What our clients say

Maria Galligan, PMD Solutions

" The Clindox team have been an incredible support and are always available to help in any way they can."

Dr Salvi, CRF Health, India

" The time and cost saving is really significant. We're very happy with the performance or CRFweb and I wouldn't hesitate to recommend it."

Nigel McLean, Cytosystems, UK

" CRFWEB eCRF, plus their helpful and accommodating staff, helped us quickly set up and personalize, with quick turn-around times of modifications, exactly what we, the clinical staff, and statistical consultants demanded, all at an affordable price "

Kelly Seamans, Atlantia

" The Clindox (CRFWEB) team are dedicated and enthusiastic about accommodating the unique requirements of each individual study and are great value for money."

Dr Satish Kumar, G7 Synergon

"Our international CRO business has utilized Clindox's integrated randomization module and Kit Management. The functionality provides everything we need, and having key trial components integrated into one system is a huge advantage to us in terms of trial efficiencies. Having both randomization and kit management capabilities, aligned with the EDC really simplifies the whole process and significantly reduces the time and effort required to manage our studies and keep control of our processes and inventory. "

Next Steps

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