High qualifications

MEDSHARING's only aim is to provide quality Internet tools within predefined and respected budgets.

To meet our commitment, MEDSHARING maintains and continuously improves its Quality Management System that supports our core business. Our Quality Management System was developed to ensure high quality and a consistent supply of products and services by implementing the recommendations related to our business areas.

• MEDSHARING commits itself to a process of continuous quality improvement.
• MEDSHARING is ISO 9001 certified for all its management and engineering processes.
• MEDSHARING is compliant with FDA 21 CFR part 11 (U.S. regulations).
• MEDSHARING meets the French and European regulations (Directive 2001/20/EC of April 4, 2001 and the Act of August 9, 2004)
• Medsahring meets GDPR requirements on personal and sensitive data.

Compliance with the CFR PART 11 standard

Access management:

• Application of the rules for open system;
• Access refused after a configurable number of attempts;
• "ID/signature" unique per user;
• Encrypted signature in the database;
• On first access, a provisional signature is sent which must be customised by the owner as soon as he accesses the system;
• In case of loss of signature, a new temporary password is assigned to him which must be customised by the owner as soon as he accesses system;
• It is not possible to have the same signature for two different profiles;
• System prohibits obvious signatures by adding a three characters key defined by the system;
• Possibility to block access to a user;
• It is not possible to delete an account if data is associated to it;
• Traceability of all kinds of access, unsuccessful ones included;
• Unauthorised access for those who have no ID, or those who have a disabled account;
• Unable to connect simultaneously with the same account.

Management of passwords:

• The administrator of the study is the only authority who can create, enable, disable and delete user accounts;
• The administrator can not in any way delete an account in which data has already been entered;
• When creating an account, a provisional signature is sent by mail to the end user;
• The end user must be able to customise it to enter or include patients in his study;
• When he loses his ID, the end user must report to the administrator who will apply for reallocation of signature;
• At the request of reassignment, a new temporary signature is automatically generated and sent by mail to the end user who must customise it again.

Integrity and authenticity of data:

• Ensuring the integrity of data through the SQL Server;
• Ensuring the integrity of data through the work methods and procedures.
  

Audit trail and electronic signature:

• The database access is limited according to the different rights and accounts. From the website, the SQL account used to access the database is restricted to actions that strictly need it;
• All data registration is preceded by the user's signature;
• Each change is tracked in a separate table (Audit Trail) with the unique user ID, date and time of the change;
• At each recording of medical data of the database, the unique user ID is associated with the date and time of the entry;
• The ID associated and the user cannot be deleted or modified if data has been entered;
• The time Stamp Indication is carried out by the servers that are synchronised to the atomic clock via NTP (Network Time Protocol).

• Your project
• An all-inclusive package budget
• A well-tried methodology
• Designing your study
• A site dedicated to training

• Our e-CRF solutions
• EOL, e-crf 100% internet
• Handling your study
• Data collection
• Monitoring and validation
• Exporting to your tools

• Our randomization solutions
• IPhone/IPad Randomization
• IWRS Randomization
• Randomization algorithm
• Allocation of treatments
• Vocal server IVRS

• references
• Public References
• Laboratory references
• Associations references
• Customer testimonials
• Our achievements

• security and quality
• Your data secure
• High qualifications
• Unfailing availability
• Our healthcare host

• The e-crf advantages
• Quality data
• Optimal communication
• Traceability and confidentiality
• Optimized costs

EOL, the e-CRF solution

An e-CRF solution for the complete on-line management of clinical studies available on the Internet (tests, cohorts, health monitoring)

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