Quality policy

ClinSearch is committed to providing high quality services to its clients. ClinSearch thus maintains a well defined Quality System that is orientated towards international quality standards.

Our standards are based on:

  • Legal and regulatory requirements;
  • ICH — Good Clinical Practice;
  • MEDDEV;
  • AHWP guidance;
  • Good Epidemiological Practice.

Our standards are based on:

  • ISO 9001;
  • ISO 19011;
  • ISO 14155;
  • ISO 13485;
  • ISO 14971.

 

In this framework ClinSearch defines its quality policy as follows:

Quality through client focus

ClinSearch seeks excellence in all its services by closely supporting clients in the realization of their research projects.

Quality through compliance with regulations, ethical and deontological rules

ClinSearch seeks to comply with common values, fairness, and ethical rules and regulations at every level of its organization and management.

Quality through management and resource allocation

ClinSearch manages its activities-related operations by planning its resource allocation in the most efficient manner.

Quality through involvement of every employee and regular training

ClinSearch ensures high-quality service by fully engaging employees at all levels in continuous training and development.

Quality through internal and external communication on QMS and activities’ efficiency

ClinSearch ensures the development of internal and external communication on its quality management activities by producing information and awareness tools and regularly organizing meetings on issues related to quality.

Quality through continuous improvement, to constantly develop QMS efficiency

ClinSearch uses the principle of continuous improvement to develop its services and quality system.

Quality through involvement in R&D

ClinSearch invests significantly in R&D and innovation by hosting PhDs and funding their thesis work.

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 our 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 and also according to the principles that have been enacted by AdvamedEucomed 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 from both the US Foreign Corrupt Practices Act 1977 (FCPA), which has already generated billions of dollars worth of penalties, and the UK Bribery Act 2010, which came into force on July 1st, 2011.

When the industry approaches HCPs, it is in the presence of a systemic 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 evaluations, which cannot take place without the involvement of HCPs, appear as a major topic where ethical and anti-corruption principles should be applied (Figure 1).

Clinical evaluations are the only way to prove your product’s innovation: not only to obtain CE conformity but also to collect the clinical evidence that is now required for the robust file for pricing strategies and reimbursement.

ClinSearch offers solutions for clinical evaluations 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 processed only when the HCPs have performed high-quality work. In addition, HCPs are committed to declaring a conflict of interest when they are involved in scientific publications in relation to the clinical research.

Additionally, we believe that compliance can be guaranteed if the different responsibilities are well distributed among stake-holders in the clinical evaluation. Thus, for our clinical evaluation projects, ClinSearch uses in-house resources as well as independent and qualified HCPs.

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