crfwebus-blog

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CRFWeb helps in post-approval/post-marketing research | CRFweb

CRFweb is ideal for any post market (post approval) studies, but recent MDR and IVDR regulations for medical devices in Europe has upped the significance for that market in particular. If you want to market your medical device in Europe, you will need to meet compliance requirements, whether your appliance is new to market or already there. You will also need to provide ongoing evidence with respect to safety and efficacy.

CRFweb’s core attributes makes it the perfect option for post approval, post market research. Although capable of handling complex, lengthy trials, CRFweb’s super-fast, DIY set-up and simplicity of use, enables it to be put to a variety of uses. It’s ideal for putting together studies where turnaround time is of the essence and flexibility is paramount.

Our ePRO and eDIARY modules are of particular benefit to those looking at post market evaluation.

Whether your requirement is for post-marketing studies, registries, safety, observational or any other ongoing research for a product or service already in the marketplace, CRFweb can deliver a fast, efficient and bespoke solution. If you have an existing pre-market trial software system, it may well not meet your needs for post-market research. If you’re paper-based, A post-approval study can be the ideal first step into clinical trial software. Meet your regulatory and/or marketing requirements.. for a much lower outlay than you might imagine.

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Integrated MedDRA | Medical Dictionary for Regulatory Activities | CRFweb

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:

In-built MedDRA dictionary

Dictionary version available to match your license

Auto and manual mapping of MedDRA codes

Easy to use eCRF browser to search code at all levels

Export the coded study to PDF

This is complementary with CRFweb. You will need your own MedDRA license, we will validate this for you, and you are then free to use it as part of your study as long as you maintain your Licence.

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Fully integrated electronic Patient Reported Outcome ePRO module | CRFweb

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.

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A clinical trial software system simple quick & easy to use

CRFweb is the game-changing clinical trial software system which is web-based and is incredibly quick to set up remarkably simple and intuitive to use.

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.

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CRFWeb helps in BA/BE Bio availability and Bio equivalence  | CRFweb

CRFWeb helps in BA/BE Bio availability and Bio equivalence by providing ePRO and eDiaries in a more efficient way when compared to others.

BA BE studies Bio availability and Bio equivalence studies typically require rapid turnaround. Short studies have typically been the domain of paper trials due to the lengthy set up time and costs of traditional systems being impractical.

Increasing Regulation Those involved in BA/BE studies are currently finding themselves under pressure to adhere to new regulations and guidelines. This inevitably increases the volume and complexity of the paperwork required. Read more about the impact of regulations on BA-BE studies by following the link.

How CRFweb can help CRFweb, can help with all of this. In terms of turnaround, a simple BA-BE study eCRF can be set up in as little as a day on our EDC platform. If needed we can offer patient-reported outcomes, ePRO, and eDiary. Relevant reports, sample documents etc can be uploaded onto our eTMF (electronic trial master file) module. Critically for regulation and audit purposes, all activities have an audit trail.

A comprehensive range of standard reports are available and bespoke ones can be created if needed to facilitate swift and efficient hand over to your statistician.

Your BA BE study will be created on a system that is FDA compliant and to GCP (Good Clinical Practice) standards.

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Technology partner for Contract Research Organisations CROs | CRFweb

As a technology partner for Contract research organisations CROs CRFWeb offers eCRF, ePRO, eDiary, eTMF, MedDRA coding, double data entry, randomisation.

CRFweb is a state-of-the-art EDC application, developed from the ground up to deliver a system that offers the key features you will see among the big name market leaders, but at a fraction of the cost. Most importantly we are set up to work as a technology partner for CROs.

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CRFweb for Pharma for post-approval/post-marketing research

The core attributes of CRFweb for Pharma makes it the perfect option for post-approval/post-marketing research.CRFWeb is the ideal application to design, capture, manage and report on your Pharmaceutical clinical trials. Built from the ground up with simplicity, usability, security and compliance in mind, CRFweb’s EDC platform has matured into a multi-faceted solution for your pharmaceutical investigations. CRFweb has all the core features you would require: formulas, edit checks, logs, queries, validation, comprehensive reporting suite and more. It also offers MedDra dictionary coding, ePRO, eDIARY and eTMF functionality all of which are integrated.

CRFweb is tried, tested and proven in the marketplace and is available at a fraction of the cost of the industry bigger names. Learn more about how the CRFweb EDC process Can help you manage your pharmaceutical clinical trials.

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Fully integrated eDiary module | CRFweb

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.

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CRFweb is an eCRF application for clinical trials | CRFweb

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… whether this is ePRO, eDiary or eTMF. All our features are available from a simple dashboard and can be independent or integrate as required.

The eCRF allows simple design and data capture for your study, with straightforward sections and questions by visit basis. Complete flexibility on user level access is simple to set up. The CRFweb eCRF application allows query management, reminders, logs, formulas and edit checks, and a comprehensive reporting suite.

Together with our simple interface and logical architecture, this means that CRFweb is designed for maximum flexibility. If you build a study by designing a CRF in the system and you’d like to add patient-reported outcomes via ePRO, it’s straightforward, if you want to add eDiary features and reminders, that’s no problem… it’s all done from your dashboard. Wherever the data is captured it will sync and there will be an audit trail.

Take a look at how to construct and manage a study in our EDC process section, request a demo or call for further information.

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Integrated MedDRA | Medical Dictionary for Regulatory Activities | CRFweb

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:

In-built MedDRA dictionary Dictionary version available to match your license Auto and manual mapping of MedDRA codes Easy to use eCRF browser to search code at all levels Export the coded study to PDF This is complementary with CRFweb. You will need your own MedDRA license, we will validate this for you, and you are then free to use it as part of your study as long as you maintain your Licence.

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CRFweb comes with integrated electronic Trial Master File (eTMF)

CRFweb comes with integrated electronic Trial Master File (eTMF) which allows managing, grouping, uploading, sharing and much more features.

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.

CRFweb

helps companies capture data from clinical trials more easily, efficiently and cost-effectively. Many products in the eCRF field and in the wider CTMS domain make similar claims, but CRFweb delivers all the key functionality you need in an agile and simple to use package… at a fraction of the cost of the industry big names.

We’ve developed our software from the ground up so that it’s intuitive to use and doesn’t require a third party to set up. The control is back with the trial manager and the time and cost savings are immeasurable.

There’s no need for any installation. It’s web-based, secure and compliant. You can build it yourself or we will build it for you. We believe in a partnership approach to EDC and our excellent customer service team will provide support wherever needed. CRFweb provides an end-to-end solution for creating, editing, conducting and monitoring clinical trials that also enables clients to interrogate data as well as exporting it to third-party systems. Remote users can capitalize on the use of mobile technology, collating data while with a subject and recording it in real-time directly to their database. Or capture the data direct from the subject with ePRO or eDiary Talk is cheap, and ultimately the only way for us to back up our claims is to show you the system. See how the CRFweb EDC process works or arrange a web demo.

CRFweb helps companies capture data from clinical trials more easily, efficiently and cost-effectively. Most products in the eCRF field and in the wider CTMS domain make similar claims, but Clindox only exists because our research and feedback suggest that’s generally not the case. Others require you to conform to their complicated systems, where CRFweb conforms to your trial. We’ve developed our software from the ground up so that it’s intuitive to use and doesn’t require a third party to set up. The control is back with the trial manager and the time and cost savings are immeasurable.

There’s no need for any installation. It’s web-based, secure, and we provide support if needed. CRFweb provides an end-to-end solution for creating, editing, conducting and monitoring clinical trials that also enables clients to interrogate data as well as exporting it to third-party systems. Remote users can capitalize on the use of mobile technology, collating data while with a subject and recording it in real time directly to their database.

Talk is cheap, and ultimately the only way for us to back up our claims is if you give us the opportunity to prove them. Please take a look at our setup guarantee offer. We can set up an averagely sized eCRF in just 2 days. In as little as 48 hours you could be trialing our EDC system for your own CRF. The first step is to arrange a web demo.

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CRFweb is an edc (electronic data capture) application for clinical trials

CRFweb is an edc (electronic data capture) application for clinical trials which has a simple dashboard and can be independent or integrate as required.

EDC (Electronic Data Capture) with CRFweb is about taking control of your trial. The CRFweb HTML Editor suite is easy to use and intuitive. Designed to have the look, feel and functionality of typical office software suites, CRFweb’s EDC gives instant familiarity. Only rudimentary training is required to understand the process. It’s genuinely DIY, but our customer support team is available to design the study if required or assist you when designing your own.

This section pertains to the process for an eCRF, though the principles are the same for both eDIARY and ePRO, with just the method of capture varying.

Here’s how it all works: Design the eCRF Capture data Manage Data Report Study design

Next you add and edit the key components of your EDC study (eg. Medicine log or incident log) from our CRF log. The system structures all interview questions on a visit by visit basis, so the next step is to set up and design those visits. All questions related to a specific visit to the subject are set here and can be grouped into multiple sections to accommodate complex or multiple questions as appropriate. You can create your own questions or add them from a template or question bank. The system now offers multi-language capability, which can be set at the design stage. Once your first CRF has been set up, you can use it as a template for future work and edit as required.

Capture Data:- The data capture element to CRFweb EDC is a simple process. Everything is ergonomically designed for ease of use. From the dashboard, just click on the ‘input data to a CRF’ icon and away you go. It’s just one click to the main areas of the process and one click back again. Users are taken through a step by step process for data entry and you can save and review saved work as you go. You can add a new subject here and/or allocate a subject to a CRF. The Colour-coded process bar gives each user a clear overview of each subject’s status within a study. When with a subject, the investigator simply goes to the appropriate visit and all the information required, and questions to ask, are simply and clearly laid out.

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CRFWeb helps in post-approval/post-marketing research

CRFweb’s core attributes make it the perfect option for post-approval/post-marketing research.

CRFweb is ideal for any post market (post approval) studies, but recent MDR and IVDR regulations for medical devices in Europe has upped the significance for that market in particular. If you want to market your medical device in Europe, you will need to meet compliance requirements, whether your appliance is new to market or already there. You will also need to provide ongoing evidence with respect to safety and efficacy.

CRFweb’s core attributes makes it the perfect option for post approval, post market research. Although capable of handling complex, lengthy trials, CRFweb’s super-fast, DIY set-up and simplicity of use, enables it to be put to a variety of uses. It’s ideal for putting together studies where turnaround time is of the essence and flexibility is paramount.

Our ePRO and eDIARY modules are of particular benefit to those looking at post market evaluation.

Whether your requirement is for post-marketing studies, registries, safety, observational or any other ongoing research for a product or service already in the marketplace, CRFweb can deliver a fast, efficient and bespoke solution. If you have an existing pre-market trial software system, it may well not meet your needs for post-market research. If you’re paper-based, A post-approval study can be the ideal first step into clinical trial software. Meet your regulatory and/or marketing requirements.. for a much lower outlay than you might imagine.

Contact us today to arrange a web demo and see how we can assist your post market evaluations.

While suitable for any post-market studies, recent MDR and IVDR regulations in Europe has upped the significance for medical devices in particular. If you want to market your medical device in Europe, you will need to meet compliance requirements, whether your appliance is new to market or already there. You will also need to provide ongoing evidence with respect to safety and efficacy.

CRFweb’s core attributes makes it the perfect option for post-approval, post-market research. Although capable of handling complex, lengthy trials, CRFweb’s super-fast, DIY set-up and simplicity of use, enables it to be put to a variety of uses. It’s ideal for putting together studies where turnaround time is of the essence and flexibility is paramount.

Our ePRO and eDIARY modules are of particular benefit to those looking at post market evaluation.

Whether your requirement is for post-marketing studies, registries, safety, observational or any other ongoing research for a product or service already in the marketplace, CRFweb can deliver a fast, efficient and bespoke solution. If you have an existing pre-market trial software system, it may well not meet your needs for post-market research. If you’re paper-based, post-marketing can be the ideal first step into clinical trial software. Meet your regulatory and/or marketing requirements.. for a much lower outlay than you might imagine.

Contact us today to arrange a web demo and see how we can assist your post-market evaluations.

[crfwebus-blog]

Are you compliant? Recent European MDR and IVDR regulations have made significant changes to compliance in the medical device industry and similar legislation 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 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, whilst providing all the reporting outputs needed.

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.

The solution is now here. It’s tested, proven and currently helping medical device companies meet their compliance requirements.

It’s not too late to join them. Call now for a demo.

[crfwebus-blog]

Are you compliant? Recent European MDR and IVDR regulations have made significant changes to compliance in the medical device industry and similar legislation 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 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, whilst providing all the reporting outputs needed.

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.

The solution is now here. It’s tested, proven and currently helping medical device companies meet their compliance requirements.

It’s not too late to join them. Call now for a demo.

[crfwebus-blog]

CRFWeb helps in BA/BE Bio availability and Bio equivalence

RFWeb helps in BA/BE Bio availability and Bio equivalence by providing ePRO and eDiaries in a more efficient way when compared to others.

CRFWeb helps in BA/BE Bio availability and Bio equivalence by providing ePRO and eDiaries in a more efficient way when compared to others.

How CRFweb can help CRFweb, can help with all of this. In terms of turnaround, a simple BA-BE study eCRF can be set up in as little as a day on our EDC platform. If needed we can offer patient reported outcomes, ePRO, and eDiary. Relevant reports, sample documents etc can be uploaded onto our eTMF (electronic trial master file) module. Critically for regulation and audit purposes, all activities have an audit trail.

A comprehensive range of standard reports are available and bespoke ones can be created if needed to facilitate swift and efficient hand over to your statistician.

Your BA BE study will be created on a system that is FDA compliant and to GCP (Good Clinical Practice) standards.

Call us now or request a demo to arrange a web demonstration

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CRFWeb the technology partner for Contract research organisations CROs

As a technology partner for Contract research organisations CROs CRFWeb offers eCRF, ePRO, eDiary, eTMF, MedDRA coding, double data entry, randomisation.

CRFweb is a state-of-the-art EDC application, developed from the ground up to deliver a system that offers the key features you will see among the big name market leaders, but at a fraction of the cost. Most importantly we are set up to work as a technology partner for CROs.

Helping you win Business By recommending CRFweb as your technology partner you will be offering clients:

The key features they will need in an integrated, user-friendly, fast to set up, robust and proven package: eCRF, ePRO, eDiary, eTMF, MedDRA coding, double data entry, randomisation. Competitive pricing

                     FDA compliance and the latest in data security You will be able to include our ‘CRFweb Our Technology Partner’ brochure and FAQs in your pitch document. We are happy to discuss co-branding

Our partnership approach continues when the business is secured.

We can handle study set up for you, or you can very quickly learn to do this your selves Dedicated customer support and development teams will work with you as your technology partner. This means:

You will get through training and free customer support

You will get rapid response and resolution to any customer service queries

If a particular study requires any bespoke work, we will identify this early and provide a timeline project plan.