“SECURING YOUR CLINICAL TRIAL DATA”
INFORMATION ABOUT THE DATA YOU PROVIDE TO US TO ESTIMATE CLINICAL TRIAL COSTS
SOFPROMED INVESTIGACIÓN CLÍNICA, SL is the owner of the Clinical Trial Cost Calculator (CTCC) software application.
It is very important to us that you fully understand what we are going to do with the clinical trial data we request from you.
We will be transparent and ensure you have control over your clinical trial data, using plain language and clear options that will allow you to decide what we can do with your clinical trial data.
If anything is unclear after reading this information, please do not hesitate to contact us.
Thank you for your cooperation.
Who are we?
- Company name: SOFPROMED INVESTIGACIÓN CLÍNICA, S.L.
- VAT ID: B57757619
- Primary activity: COMPREHENSIVE MANAGEMENT OF CLINICAL TRIALS AND OBSERVATIONAL STUDIES
- Address: GRAN VÍA ASIMA 20, 3rd Floor, Office 23, 07009, Palma de Mallorca (Balearic Islands, Spain)
- Telephone number: +34 617273604
- Email address: email@example.com
- Website: www.sofpromed.com
For your peace of mind and security, we are inscribed in the following Spanish Public Registry / Commercial and Trade Registry: Entry number 1/2012/5948.0, journal 225, entry 4312, registered on 4 May 2012, in volume 2496, folio 143, entry 1 with page PM-69556.
We are at your disposal, do not hesitate to contact us.
Nature of the clinical trial data we request from you
To calculate the costs of your clinical trial, we need some essential study specifications that are entered into our CTCC software application.
The specifications we request are general in nature and are not intended to include confidential data that can identify a particular clinical trial.
In terms of study identification, we only ask for a non-confidential general reference of your choice, so that you can remember the project you had in mind.
What clinical trial data do we request from you?
When using our CTCC software application, you will have to insert the following data:
- Basic information: Study non-confidential reference or identifier, phase, therapeutic area, number of patients, number of sites, number of countries, location of the countries, number of EDC forms, and comments (if any).
- Monitoring visits: Number of onsite monitoring visits foreseen.
- Optional CRO services you need.
- Optional pass-through costs you want to include.
- Clinical trial timelines for recruitment, treatment, and follow-up.
Why do we need to use your clinical trial data?
We need the clinical trial data mentioned above to estimate the costs of your study (this will be done automatically by our CTCC software tool). Then, we will be able to provide you with the quote you asked for.
Secondly, we may use your clinical trial data to contact you (in a very discreet manner) and ask you whether you may be interested in our services or in receiving a more personalized quotation.
With whom will we share the data you provide?
Only the staff members of SOFPROMED INVESTIGACIÓN CLÍNICA, SL who have been fully authorized may have access to the clinical trial data we ask you to provide.
In addition, duly authorized technical staff of the company ZLYNGER SOFTWORKS, SL (a subcontractor of SOFPROMED INVESTIGACIÓN CLÍNICA, SL) may have access to the clinical trial data you provide. This is the software company that developed and maintains the CTCC software application.
We will not share your clinical trial data with anyone else.
Nevertheless, if we need to disclose your clinical trial data to other entities, we will ask your permission beforehand, providing you with clear options that will allow you to decide in this respect.
Where will your clinical trial data be stored?
The clinical trial data you insert into the CTCC software application will be stored in a secure database. The server is physically located in Spain and is supervised by the technical staff of ZLYNGER SOFTWORKS, SL.
How do we protect your clinical trial data?
We protect your clinical trial data using effective security measures in proportion to the risks involved in using your information.
Will we transmit your clinical trial data to other countries?
Many countries across the world offer secure protection for your data, while others not so much. The European Union, for example, is a secure environment for your data. Our policy is not to send your clinical trial data to any country that does not offer secure protection for your clinical trial data.
In the event that we need to send your clinical trial data to a country that is not as secure as Spain in order to deliver our services to you, we will always ask your permission beforehand and apply effective security measures to reduce the risk of sending your clinical trial data to another country.
How long will we retain your clinical trial data for?
We will store your clinical trial data (associated to your personal data) in our servers for the duration of our relationship (as long as you are a registered user of the CTCC software application) and subsequently as described below.
Once you are unsubscribed from the CTCC, we will then completely erase your personal data in a secure and environmentally friendly manner.
However, the clinical trial data provided by you (to calculate the budgets) will indefinitely remain in our servers but not associated to your personal information (fully anonymized).
This means we will keep the clinical trial data related to your budget estimations, but we will not know who entered the data. This information will no longer be linked to you.
How can I unsubscribe from the CTCC?
To unsubscribe from the CTCC and have your personal data erased from our systems, please send an email to firstname.lastname@example.org with this information:
- Subject: CTCC Unsubscribe
- Email text: Please unsubscribe me from the CTCC. The email I used was: [your email address]
What are your rights when it comes to the protection of your clinical trial data?
The clinical trial data inserted in our systems will not be erased.
You can unsubscribe from the CTCC at any time to have your personal data erased, but the clinical trial data related to your budget calculations will remain in our servers for an indefinite period of time, not linked to your personal information (it will be fully anonymized).
Can you withdraw your consent if you change your mind later?
You can withdraw your consent at any time if you change your mind about the personal data you entered in the CTCC software application.
However, the clinical trial data entered, which we use to calculate the budgets, will indefinitely remain in our systems.
Once you unsubscribe from the CTCC, your personal data will be erased, and the clinical trial data will remain stored in our servers but not associated to your personal information (it will be anonymized).
Do we build profiles about you?
For service or marketing purposes, we may need to develop information profiles about you.
An example would be the use of your CTCC software use history to enable us to offer you products or services tailored to your tastes or needs.
In these cases, we will apply effective security measures to protect your clinical trial data at all times against unauthorized persons intending to use it for their own benefit.
Do we use your clinical trial data for other purposes?
Our policy is not to use your clinical trial data for any purposes other than those that we have explained. However, if we need to use your clinical trial data for another purpose, we will always ask your permission beforehand, providing you with clear options that will allow you to decide.