Medical Devices

Medical Device Investigations

An Elevated View Of Compliance And Regulations Word Written On Pieces Of Jigsaw Puzzle

Making sense of the global market

Are you compliant? Everywhere you need to be? Recent European MDR and IVDR regulations have made significant changes to compliance in the medical device industry and legislation tightening compliance requirements is being brought in around the world. Not only do new Medical Device Trials require evaluation on grounds of safety and efficacy, but existing products are also being required to demonstrate the same. The clock is ticking. CRFweb is proven in the medical devices field and can help facilitate a rapid turnaround of design and data entry for your investigation, whilst providing all the reporting outputs needed.
  • FDA Compliant
  • GDPR compliant
  • Medical Device specific logs: AE, ADE, SAE, SADE, USADE
  • Randomization for sham-controlled trials

Paper, spreadsheets and eCRF

If you have current data in paper or spreadsheet format, we can develop an eCRF from that and import spreadsheet files as appropriate. If you are considering using spreadsheets as an alternative to an eCRF however, we strongly recommend you take advice first. An eCRF designed correctly on an EDC database like CRFweb, with the requirements of Medical Device investigations in mind, will provide a full electronic audit trail and a host of additional features to make your study manageable and reportable. Can you risk your regulatory body turning down your application?
A fast to set-up but fully functioning, flexible, reliable and cost-effective system to manage medical device clinical trials is no longer a nice to have. Its a critical element to get your product to market. And a critical element to keep your product compliant post-market.
Medical equipment on table. Blue stethoscope and tablet on white background.
Medical equipment on table. Blue stethoscope and tablet on white background.

Paper, spreadsheets and eCRF

If you have current data in paper or spreadsheet format, we can develop an eCRF from that and import spreadsheet files as appropriate. If you are considering using spreadsheets as an alternative to an eCRF however, we strongly recommend you take advice first. An eCRF designed correctly on an EDC database like CRFweb, with the requirements of Medical Device investigations in mind, will provide a full electronic audit trail and a host of additional features to make your study manageable and reportable. Can you risk your regulatory body turning down your application?
A fast to set-up but fully functioning, flexible, reliable and cost-effective system to manage medical device clinical trials is no longer a nice to have. Its a critical element to get your product to market. And a critical element to keep your product compliant post-market.
rsz_products_to_market_section-1

Pre-Market or Post-Market

You may be facing challenges to gain compliance for your pre-market device. You may be requiring ways to demonstrate your existing appliance meets new regulatory requirements… or continues to meet them.
CRFweb can help with either of these situations. If you need an investigation, we can do it. We understand the specific challenges of the Medical Device industry and we have the system capability to meet them.

Meeting the specific demands of Medical Device Clients

CRFweb is being used by numerous medical device clients in a number of countries. We understand the needs of medical device investigations. We have a template library of relevant medical device adverse event/effect logs – AE, SAE, ADE, SADE, USADE. We can perform sham-controlled randomized trials with our randomization module. We have eDiary and ePRO for patient led data collection and MedDRA coding to tie in to standardised definitions if required. Learn more about our key products and features here:
rsz_meeting_demands_of_medical_device_clients-1
rsz_meeting_demands_of_medical_device_clients-1

Meeting the specific demands of Medical Device Clients

CRFweb is being used by numerous medical device clients in a number of countries. We understand the needs of medical device investigations. We have a template library of relevant medical device adverse event/effect logs – AE, SAE, ADE, SADE, USADE. We can perform sham-controlled randomized trials with our randomization module. We have eDiary and ePRO for patient led data collection and MedDRA coding to tie in to standardised definitions if required. Learn more about our key products and features here:

Products and Features

The EDC process

null

eCRF

CRFweb is an EDC (Electronic Data Capture) application for clinical trials. Core to the proposition is an electronic case report form or eCRF which forms the hub of the application. The key ethos behind CRFweb is integration and consequently all our other functionality integrates with the CRF

Explore More

null

ePRO

CRFweb now features a fully integrated ePRO (electronic patient reported outcome) interface, where subjects can answer questionnaires without risk of accessing other functionality or data. Site staff can easily initiate a subject session to allow the subject to answer at the clinic (e.g. using a tablet), or the subject can log in from home with a unique username and password. A study can be designed to be entirely ePRO. It’s also possible for a particular visit within a study to be designed as ePRO, giving ultimate flexibility in study design. With data entry by the subject, both ePRO and the complimentary eDiary module, lend themselves especially well to post-market studies. In addition to the obvious time and cost saving benefits, there is also the benefit of increased patient engagement in the whole trial process. Features summary: Multilingual patient questionnaires/surveys Easy switch to subject entry mode Subject login from home Data entry on tablet No risk of subject accessing other functionality or data Scheduling and reminder facility.

Explore More

null

eDiary

Like all features of CRFweb, the eDiary function is integrated into the application. Working alongside our ePRO functionality, eDiary allows greater interaction with the subject through login via mobile device for daily observations and improving data collection response through reminders and alerts. Core functionality: Prepare a schedule / calendar for data capture and assign subjects intended to be part of the study Login through Android / iOS devices to record daily observations Complex formulas and edit checks to manage the study complexity Notification to investigators/Nurses to visit Subject on any observations during data capture No risk of subject accessing other functionality or data Notification/Alerts to Subject for any data which needs quick action by Subject eg Visit to Doctor, Nurse, etc For a demo please fill in our demo request form or call for further information.

Explore More

null

MedDRA

Dictionary coding is a regulatory necessity for many trials and an advantage for many more. The clear market leader in this area with the broadest recognition is MedDRA (Medical Dictionary for Regulatory Activities). CRFweb has MedDRA coding integrated into our application and offers the following key functionality:

Explore More

null

Randomization

CRFweb offers simple, block and stratified randomization. The randomization module allows clients to randomize subjects in two way. Option 1 allows for randomization as a group of subjects in circumstances where all subjects are known. This allows for sampling and control groups according to requirements. Option 2 is to randomize ‘on the fly’. Allowing treatment groups to be randomly assigned to a subject by the investigator in real time.

Explore More

null

eTMF

CRFweb has integrated electronic Trial Master File (eTMF) functionality. This enables clients to; Manage eTMF documents Group the eTMF documents Upload the documents or images for a particular study Share study protocol document to users of a study Full feature WYSIWYG (What you see is what you get) editor for adding details Access questionnaire and licence requirements and validate the same Please call or fill out our web demo request form to find out more about our integrated eTMF.

Explore More

image-2800-x-1867

Partnering with experts – need a CRO ?

We understand you may have a CRF/Investigation protocol ready to go. We also understand you may not be at that stage yet. We recommend Devicia as a “go to CRO” for their experitise in all things medical device related. Whether this is plotting a path through the minefield of international regulatory guidance, report writing or, of course, designing clinical investigations. They are also very familiar with our application, ensuring a smooth integration of your research requirements into compliant EDC. If you need help with your investigations, give them a call.

The End of Paper-based Trials?

The End of Paper-based Trials?

Is this ‘ The End of Paper-based Trials? ’ Download our feature on the four reasons why companies still use paper-based trials… and why they no longer need to

Client Testimonials

Client Testimonials

"As a leading Medical Device CRO, we understand the importance of a specialist EDC application in today’s market. I have..." Read More

Elisabeth Liljensten, CEO, Devicia AB

"We’re very happy we chose CRFweb. We now feel we have greater control over our trial management process, our trials..." Read More

Maria Galligan, PMD Solutions

"Cytosystems is running a multi-centered clinical performance evaluation study for its proprietary urine based diagnostic for bladder cancer.  We require..." Read More

Nigel McLean, Cytosystems, UK

Latest News

CRFweb Latest News