The ethica CRO Difference
Leaders in research ethics.
Since its inception in 2002, ethica CRO has dedicated its efforts to bringing a new dimension to the clinical research industry, the ethical dimension. Focused on integrating research participants as partners in research rather than simply subjects of research, ethica CRO places the research participant at the center of its standard operating procedures, research activities, and business pursuits.
ethica CRO offers small to mid-tier international pharmaceutical, biotechnology and medical device companies something no one else does, a participant-centric risk management platform.
The benefits to our clients
By placing the research participant at the heart of its activities, ethica CRO built a strong culture of responsible human research conduct at all levels of the organization. ethica CRO’s approach to clinical research provides numerous benefits to its clients, including:
Streamlined procedures, leading to increased efficiencies
Risk-reduction consciousness that results in a safer environment for research participants
Detailed and accurate record-keeping procedures
Less likelihood of downtime during regulatory inspections
Assurance that all federal and local regulations and guidelines are met or exceeded
Credible and reliable data that can support regulatory applications.
Avoid the common regulatory inspection pitfalls
Clinical research endeavours have inherent risks and uncertainties that can cause your research to fail if not appropriately addressed at project inception. Through its comprehensive and accredited Human Research Protection Program, ethica CRO is equipped to mitigate the known risks of your research, maximize research benefits, and help you manage unforeseen situations.
Common Sponsor/CRO FDA Inspection Deficiencies
Common Sponsor/CRO Health Canada Inspection Deficiencies
Between 2017 and 2019, the FDA conducted 370 Sponsor/CRO/Monitor inspections where an average of 30% of the findings involved non-compliant, objectionable conditions or practices. Over the past four years, failure to fulfill sponsor obligations represented on average 66.5% of Health Canada’s inspection findings.
ethica CRO’s proven method
ethica CRO services are rooted in a comprehensive risk-management system that is fortified by continuous quality assurance auditing.
ethica CRO was the first Contract Research Organization (CRO) in the world to be accredited for its Human Research Protection Program in 2006. It is the only CRO in the world to have achieved accreditation from three different accrediting bodies.
Human Research Protection Program (HRPP) accreditation by an independent, industry-recognized organization confirms that ethica CRO’s processes safeguard the respect and protection of research participants, and that its services meet or exceed industry standards.
ethica CRO’s accredited Human Research Protection Program withstands the scrutiny of regulatory inspections. Through flawless regulatory inspections the Food and Drug Administration and Health Canada have attested to the quality of ethica CRO’s research. In support of the preapproval process of a client’s therapeutic product, ethica CRO recently underwent an FDA Bioresearch Monitoring (BIMO) inspection of a four-year research program involving two pivotal studies. The four-day on-site inspection involved a comprehensive review of the conduct, data analysis, and reporting of the studies and resulted in no FDA Form 483 issued.
ethica CRO’s singular purpose is bringing therapies to market that will improve the standard of care. ethica achieves its purpose through advanced study designs, trial procedures, data analyses, and its participant-centric risk management platform. This is the ethica CRO difference!
ethica CRO’s HRPP Mission
The mission of ethica CRO’s Human Research Protection Program is to protect the rights, dignity, welfare, and privacy of humans who participate in research projects under its supervision.
ethica CRO’s Guiding Ethical Principles
ethica CRO holds humans in high esteem and recognizes that their interests are multiple and interdependent, and their fundamental freedoms are to be fully respected. ethica CRO believes that the interests and welfare of the individual have priority over the sole interest of science or society.
ethica CRO’s guiding ethical principles:
Bring More Good than Harm
Ensure Scientific Validity and Pertinence
Respect Individual Autonomy
Respect Vulnerable Persons
Respect the Principle of Justice
Ensure the Non-Commercialization of the Human Body
Respect Privacy and Confidentiality
Guided by these principles, ethica CRO may suggest modifications to a client’s proposed study design or decline a request for proposal if the research project compromises the protection of research participants’ rights and welfare.
Make a difference with ethica CRO
Have any questions about how ethica CRO can make a difference for your clinical study or want to submit a request for proposal from our CRO? Get in touch via our contact page we will get back to you as quickly as possible.