Values and commitments

/Values and commitments
Values and commitments Emmanuel Sanchez 2018-04-14T10:55:17+00:00

VALUES AND COMMITMENTS

QUALITY POLICY

ITEC Services is committed to respecting the regulations in force in the Clinical Research with a monthly and solid regulatory monitoring conducted at the French, European and International levels :

  • This watch allows us to perform an impact analysis on all of our standard operating procedures and procedures in order to maintain the regulatory compliance of our services in terms of Good Clinical Practice (ICH E6 R2), Good Epidemiological Practices (ENCePP Guides ), Good Pharmacovigilance Practices and Good Data Management Practices.
  • Annual training on PCBs / BPE is conducted, as well as annual training on pharmacovigilance.

Our regulatory watch also includes all other regulations relating to the good conduct of a company, in accordance with the commitments defined by:

  • Our Quality Management System (ISO 9001: 2015)
  • Our Information Security Management System “ISO 27001/21 CFR Part 11 / RGPD and CNIL”,
  • Our ETHICAL CODE,
  • Our HR Policy and our commitment to Respect People
  • Our DRIVING POLICY, ANTI-CORRUPTION COMMITMENT
  • Our Policy of PREVENTING CONFLICTS OF INTEREST

The objectives of the ITEC Service Quality Policy are :

Set up Research involving human subjects, intervention, at-risks and low constraints studies and non-interventional, in accordance with applicable regulations and with the Good Professional Practices (GCP, GEP…), especially respecting patient’s rights and safety.

SAFETY

Design clinical development plans with strong scientific rigor, set up specific plans for each project and ensure the qualification and training of team involved to ensure data reliability and the integrity of the results of our studies.

 

INTEGRITY

Ensure compliance with applicable regulations in clinical development and during health products life, protocols and study plans, applicable standard operating procedures, specifications and contracts.

 

COMPLIANCE

To set up and ensure the continuous improvement of our quality system, ITEC Services has chosen the ISO 9001 standards for its “Quality Management System” and ISO 27001 for its “Information Security Management System” (based on risk approach).

INFORMATION SECURITY

The Information Security Management System (ISMS) policy is to protect all information exchanged with our customers, employees, subcontractors, service providers and other stakeholders.

Services are providing in compliance with ISO 27001, 21 CFR Part 11, RGDP and CNIL requirements.

ETHICAL CODE

We do not compromise on our integrity. To preserve it and preserve our durability, we :

  • We are honest, and we respect laws and human rights
  • Do not act in a way that could lead us to depend on other parties and obstruct our integrity and impartiality
  • Do not release any confidential information
  • Do not offer or accept gifts or other benefits that might be perceived as influencing our impartiality or behavior
  • Will not use any confidential information for personal profit
  • Will only use subcontractors who share our ethical values

All our employees receive these information during their integration process and the means needed to act responsibly and in accordance with the ITEC Services SAS Ethic Codes and Anticorruption instructions.

Our Ethical codes must commit us to respect the following fundamental principles :

  • Integrity
    Our employee’s integrity is the basis in the confidence and credibility given to their judgment. They must carry out their activities with honesty, diligence and responsibility. They must comply with the law and must not engage in fraudulent activities or engage in acts of dishonor to the profession and to ITEC Services SAS.
  • Impartiality
    Employees must carry out their activities without being influenced in their judgment by their own interests or by others. Anything that may affect their judgment must be reported to their supervisor or to the Head of ITEC Services SAS.employees respect the value and ownership of the information they receive from each promoter, site and other stakeholder. This information is divulged only with required authorization.
  • Confidentiality
    ITEC Services SAS employees respect the value and ownership of the information they receive from each promoter, site and other stakeholder. This information is divulged only with required authorization.
  • Expertise
    ITEC Services SAS employees are recruited according to the required level of competence and use their knowledge, expertise and experiences to carry out their activities. Training is a priority for developing and to adapt internal competence level.

RESPECT FOR PEOPLE

ITEC Services is committed and ensure to keep a stimulating, creative and non-discriminatory work environment for all employees, while respecting people’s diversity and dignity.

ITEC Services prohibits all forms of discrimination based on gender, age, origin, religion, sexual orientation, physical appearance, state of health, disability, and any behavior that may affect people’s dignity.

HUMAN RESOURCES POLICY

ITEC Services HR Policy ensures a constant match between the skills needs and the available human resources. ITEC Services ensures that each new employee has the required skills and is selected in accordance with his values ​​and ethical code.

ANTI-BRIBERY POLICY

Corrupt practices are a serious risk for the business durability and the company’s independence. Corruption is totally in contrary to ITEC Services values, and the involvement of any employee in corruption or fraud is unacceptable and formally prohibited.

ITEC Services has developed anti-corruption instructions aligned with Transparency International’s recommendations and guidelines.

ITEC Services is committed to fighting corruption in all its forms. Employees are expected to not accept or offer, while performing their duties : payments, gifts, services or any type of benefit.

PREVENTING CONFLICTS OF INTEREST BETWEEN ITEC SERVICES AND ITS EMPLOYEES AND/OR BETWEEN ITEC SERVICES, ITS EMPLOYEES AND CUSTOMERS

Employees may be faced with situations where their personal interests may conflict with those of ITEC Services and/or its customers. Anything that may appear as a conflict of interest can cause problems and damage ITEC Services and/or customers reputation.

To prevent situations of conflict of interest, employees must be aware of situations in which the objectivity of their professional decisions may be impaired.