- What is ShareCRF?
ShareCRF is a cloud computing platform to create and manage either clinical trials, observational studies or patient registries.
ShareCRF is a Web-Saas service (Web-software As A Service), which provides 2 main benefits:
- The user just needs any current web browser (Internet Explorer, Firefox, Chrome, Safari) and an internet connexion to be able to use ShareCRF.
- The user does not need any kind of infrastructure or technical knowledge to get access to the platform, everything is hosted in the cloud and ready to be used.
- What do I need to use ShareCRF?
The only item needed to use ShareCRF is an electronic device (computer, tablet, smartphone,...etc) with access to the internet and a current web browser (Internet Explorer, Firefox, Chrome, Safari).
- Is there any additional software installation needed to use ShareCRF?
There is no need to install any software on your devices where you wish to use ShareCRF.
- Does it work in tablets and mobile phones?
ShareCRF was built following the Mobile First Strategy, therefore, ShareCRF works perfectly in tablets, smartphones and computers.
- Who is allowed to create trials in ShareCRF?
Any entity, company or person are allowed to create trials in ShareCRF. When you sign up on ShareCRF platform, you will not have the privileges to create trials yet, but you will be able to be involved in other trials created previously. If you would like to have the privileges required to create trials, you will need just to request it via email to the following email address infoatsharecrf.com and we will provide your user the right privileges with no extra cost.
- Can I try ShareCRF platform?
Of course. The only thing you need to do is to sign up in ShareCRF.com and will be able to check the platform out without strings or cost. A quick reminder, if you wish to create any trial, just send us an email to infoatsharecrf.com and we will provide the right privileges to you.
- Do I need to have a server o technical members to use ShareCRF?
No. ShareCRF platform frees our clients from any technical installation and maintenance, therefore there is no need for our clients to have their own servers or technical people.
- ¿Is ShareCRF secure?
ShareCRF takes security as the main priority for the entire platform. Every single communication with the platform gets encrypted following the certificate RSA 2048 bits(SHA2-256) and the advanced settings to achieve the highest score A+ in the SSL Labs security test.
- ¿Whare are the servers that ShareCRF uses based?
ShareCRF uses as an infrastructure provider AWS (Amazon Web Services) and the data centres where the servers are located are in the European Union.
- ¿Are there any backups?
Of course. ShareCRF creates daily backups stored safely in multiple data centres in the European Union.
- ¿Will we meet the GDPR requirements with ShareCRF?
Yes, ShareCRF allows you to comply the GDPR requirements. The platform has been designed and built following the GDPR higher security standards required.
- ¿Does ShareCRF meet the FDA:21 CFR Part 11 and ICH:GCP requirements?
Yes, ShareCRF meets the data security and integrity requirements. ShareCRF has an inbuilt control security system that allows compliance of validation requirements and meets the FDA requirements for 21 CFR Part 11 and ICH for GCP. ShareCRF has an in-built audit trail system too that records any history data change, user access system with user and password uniques and digital signature mechanisms.
- Is there any guarantee that I will be able to access and manage the data of my trial?
Yes, as a data owner, you will have any time access to manage and download the data of your trial. This will just happen while the associated subscription to that trial is active (or during the 30 days testing period).
Features / Characteristics
- Can be defined different level of access for users?
Yes, ShareCRF allows to set up per trial different user profiles and decide which permissions will have each of them.
- Are the researches allowed to access others researcher's patients?
This functionality relies on how the roles are set up and what permissions are selected per role. The platform allows to set up different kind of roles with associated permissions per trial in which you will be able to decide if for each role the researcher will have access to others researcher's patients or will not have that access. ShareCRF allows independent configurations to be able to meet your requirements per trial, allowing you to define what type of access will have each user to the trial's data.
- Can you create data Queries?
Yes, data queries can be created (discrepancy notes) in two different ways and they can be combined in the same trial:
- Manually created by a user with the right permissions to do so.
- Automatically following a certain number of conditions that appear in the patient's data.
- What available formats can the data be exported into?
The data can be exported in CSV format which can be imported in multiple programs like Microsoft Excel and also can be exported in SPSS and SAS formats, completely ready to start working with the data in the statistical programs.
- Once the trial has kicked off, is there any chance to add either new rules or variables to the CRF?
Of course. We can also provide an incredible test environment where will be possible to validate the changes made on the CRF before they are published to the rest of the users. With this, you will be able to validate exactly the changes made and how they will affect the entire CRF before integrating them in the production environment.
Payment and subscription
- What is ShareCRF pricing policy?
On ShareCRF, each study has linked a license of use. The license determines the modules and functionality enabled in the study, as well as the license expiration date. ShareCRF uses a prepaid system, for which when making a payment of the service you obtain the rights to use the service until the date contracted, also, it allows configuring the renewals automatically (monthly or annually) of the license.
- What type of rates offer ShareCRF?
ShareCRF offers two types of rates:
- Flexible rate: It allows you to change the properties of your license freely during the life of the study, adjusting the maximum number of patients for the license to the velocity of inclusion in the study.
- Flat rate: It allows you to have a fixed price no dependent on the velocity of inclusion of the study.
- What are the allowed payment methods of ShareCRF?
- How many studies can I create in ShareCRF?
Create as many studies as you require. Each study has an independent subscription associated.
- Have all the licenses the same cost?
No, the license has different prices based on the following factors:
- The type of plan selected on the license of the study.
- The maximum number of records allowed in the study.
- The modules selected on the license.
The type of plan indicates the functionality that is going to be available in the study. There are three types of subscription that enable adapting the platform to the requirements of the study.
- Advanced Plus
- Can I change the properties of the license (type of plan, the maximum number of patients, additional modules,...) at any time?
If your license is a Flexible rate, you can change the properties at any time from the study license section, but, if your license is a Flat rate, you have to request the change to infoatsharecrf.com
- When changing the properties of the license (type of plan, the maximum number of patients, additional modules,...), what does happen?
When changing the properties of the current license, The system automatically calculates the proportional part cost pending to be consumed from the current license and deduces it from the price of the new license selected. When confirming the change, the new properties of the license are going to be updated immediately for the indicated period(monthly or annually).
- Do I either have to pay in advance or enter my credit card details to create a new study?
No, ShareCRF offers the first 30 days after creating the study free, with no commitments and no need to enter any payment information. If you want to try our platform with no commitments, Request a demonstration of ShareCRF that will bring you the opportunity to try the platform.
- What happens after the 30 days of trial when creating a new study?
If you have not created a subscription associated with the study before the trial period expires, the study begins the closing process automatically. To avoid the automatic close, you must configure the license of use associated with the study before ending the free trial period.
- What happens when a study is closed?
When the expiration date of the license of use is reached, and the license was not renewed, the study begins an automatic closing process. During the seven days after the start of the study closure will be possible to reactivate the license of use. Once these seven days have ended, the access to the study is going to be deactivated and therefore will not be possible to access it.
- If I do not have studies, do I have to pay something?
No, if you do not have a study with an active license of use, there is no associated charge for being registered in ShareCRF.
- Can I cancel the subscription at any time?
No, ShareCRF is a prepaid system and does not allow cancellation before reaching the expiration date. It is allowed to change the license as well as cancelling the automatic renewal system if you do not want to automatically renew your license of use.
- Do researchers have to pay something to use ShareCRF?
No, the ShareCRF service payment is only associated with the person who creates the study. The rest of the users invited to participate in the study do not have to pay anything.
- Are there any more extra cost associated with the ShareCRF platform?
No, there are no more costs than the one associated with the license of use selected. ShareCRF complementary offers a service of the creation of studies, documentation of validation, maintenance support and help with data migration processes, guidance in the development of advanced solutions, training courses, data recovery under request and others that can be requested by clients that are not included in the additional services guide. All of them carried out by our specialized staff and according to the needs of the study and client.
- I like ShareCRF but do not have the time to configure my eCRF. Could you do it for me?
Yes, of course. At ShareCRF we offer CRF creation additional services in which our specialized staff will design and configure the study for you.
- I am interested in creating a study. What do I have to do?
Request a demonstration of ShareCRF, and we will give you access and privileges to create studies.
- How can I find out more about ShareCRF pricing?
If you are interested in creating studies and want to find more about our prices, send us an email to email@example.com.
- If I have any question/concern about ShareCRF, What do I do?
Send us an email to firstname.lastname@example.org, indicating your phone number if you would like us to call you; we are happy to help.
ShareCRF allows the payment through credit card and bank transfer. For payments made with a credit card, we use the services provided by Stripe, one of the most well known and reliable companies in the online payment sector. Therefore, we do not store any of our client's credit/debit card details.