COMMON POLICIES - AICROS Association of International CROs
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COMMON POLICIES

All AICROS members need to comply with the common quality policies of AICROS concerning:

AICROS considers its staff is the important capital of a CRO. Our staff is extremely highly educated. To make them even better we train our staff very frequently. According to the ISO9001 principles we also measure the effectiveness of our training to ensure that the competence of our teams increase continuously. We proactively provide our clients with all training documentation for their study teams so as to avoid any audit or inspection findings

Each AICROS member has agreed to be audited independently on a bi-yearly basis. The QM systems of the members must comply with applicable clinical research related quality standards (ICH GCP and ISO14155), the national legislations and ISO9001. If a member does not pass the audit the AICROS membership is withdrawn

  • Background Information

    Corrupt acts are simply not tolerated by AICROS. All member CROs expect their employees to have a clean criminal record and to avoid any conflict of interest. All AICROS staff should be informed regularly about anticorruption rules by line managers; additional related trainings would be performed according to a business partner request or depending on an actual need. This guideline refers to US federal law called FCPA (Foreign Corrupt Practices Act), which can be followed whenever applicable for AICROS member CROs’ employees or business partners.

    Definition

    Corruption and corrupt practices implies an act of any AICROS employee attempting to obtain an unauthorized advantage by unfair pressure, bribery or other unfair practice during AICROS business customer acquisition or maintenance. Such corrupt practices also include unauthorized advantage obtained through personal contacts and contractual relationships with state officials or and the creation of any conflict of interest through these practices.

    All AICROS and AICROS member CROs’ transactions are transparently recorded in accountancy documentation and other relevant documents. A system of regular internal accounting controls is maintained to verify that neither cost reimbursements nor any cash disbursements remain unaccounted for.

    Investigation of Suspected Corruption

    All AICROS staff should be motivated and supported by member CROs’ management to share any suspicion of corrupt practices with their line managers at all times. Additionally, it is also possible to anonymously report any corrupt activity in written form to relevant managers. Any suspicion that is raised by any employee and/or relevant line manager will give enough cause to initiate an internal meeting to discuss suspected corrupt activity. The participants of the internal meeting may consist of, but are not limited to: the person who raised the suspicion; His/hers Line Manager; HR Manager, Quality Control Manager and Managing Director.

    This meeting should be conducted within 3 working days after the first notification of suspicion. The outcome of this internal meeting will be recorded in writing by Line Manager or any other member delegated by the Managing Director. The line Manager is responsible for keeping the evidence (e-mail, letter etc.) of any information transfer regarding the suspected corrupt practice including meeting minutes copy to the AICROSmember CRO HR files in a strictly confidential manner.

    If any unlawful acts are suspected, the relevant state institutions are accordingly contacted by the Managing Director.

    If a suspicion is raised on a AICROS member CRO manager, this person is replaced by his/hers senior colleague or a person on similar job position for the duration of the investigation. The replacement is carried out by the Managing Director. All suspicions are to be investigated thoroughly and in a strictly confidential manner. Maximum efforts will be made to maintain the person’s anonymity who first raised the suspicion.

    Confirmed Corruption

    In case of a confirmed corrupt act, the perpetrating employee is handed a written admonition and/or the personal penalties including job dismissal based on seriousness and other relevant factors in a concrete situation. If any unlawful acting is confirmed, those relevant state institutions are informed by the Managing Director appropriately without delay.

    This common anticorruption policy is confirmed and signed by AICROS member CROs’ Managing Directors/CEOs/Chairmen of Board of Directors:

    For GCP Services: Andreas Grund, CEO

    For Leading Clinical Research: Jiri Paseka, Chairman of Board of Directors

All AICROS member CROs’ transactions are transparently recorded in accountancy documentation and other relevant documents. The AICROSmembers regularly publish their financial results so as to show their financial ability to cover all obligations resulting from AICROS business activities

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