Compliance statement

The best way to ally market growth and compliance (with ethical principles and anti-corruption rules) is to develop innovative technology or products with healthcare professionals (HCPs).

Please see also our opinion paper on Healthcare compliance.

ClinSearch is committed to operating in a compliant and ethical manner in its customers’interests. To do so, we lead our services in compliance with the law as stated in the US Foreign Corrupt Practices Act of 1977, as amended, 15 U.S.C. §§ 78dd-1, et seq. ("FCPA") and the UK Bribery act 2010. But also according to the principles that have been enacted by Advamed, Eucomed and EDMA in their respective ethical codes in addition to the common principles that were ratified in May 2011 by nine medical device industry associations including the three mentioned above (Global Statement on Ethical Interactions Between Medical Technology Companies and healthcare Professionals). This document was first signed in May 2010 by Advamed, Eucomed and EDMA (Joint Trans-Atlantic Statement on Ethical Interactions Between Medical Technology Companies and healthcare Professionals).

In addition to these documents, a zero tolerance policy emerges both from the US Foreign Corrupt Practices Act 1977 (FCPA) which has already generated billions of dollars worth of penalties and from the UK Bribery act 2010 which will come into force in July 1st, 2011.

When the industry approaches HCPs, there systematically is the risk of developing biased relationships. However, the relationship between the industry and HCPs is necessary and legitimate in two situations — which lead to scientific improvement and medical knowledge:

1. Health product evaluation,
2. HCPs training and education.

Therefore, clinical evaluation, which cannot take place without the involvement of HCPs, appears as a major topic where ethical and anti-corruption principles should be applied (Figure 1).

It is the only way to prove your product’s innovation and therefore allow you to obtain not only CE conformity but also demonstrate clinical evidence that is now required as well as a robust file for pricing strategies and reimbursement file preparations.

ClinSearch offers solutions in clinical evaluation that meet compliance principles of the above-cited flowchart.

We are extremely vigilant concerning financial contract writing rules: financial agreements must be appropriate, fair and transparent. The contract is signed before the start of the research, and the payment is done only when an effective and quality work has been performed by HCPs.

Figure 1. Clinical evaluation: a solution to meet compliance.

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HCPs are committed to declaring conflicts of interest when they sign scientific publications in relation with the clinical research.

Additionally, we believe that compliance can be guaranteed if the different responsibilities are well distributed among actors of the clinical evaluation. Thus, for its clinical evaluation projects, ClinSearch recruits in-home resources as well as independent and qualified HCPs in terms of training and research.

Related links

• ClinSearch’s opinion paper on Healthcare compliance,
• Advamed Code of Ethics In a new window
• Eucomed Code of Ethical Business Practice In a new window
• EDMA Code of Ethics In a new window
• UK Bribery act In a new window
• US Foreign Corrupt Practices Act In a new window