CliniRx Research Private Limited together with its affiliates and subsidiaries (“CliniRx”, “we”, “us” or “our”) is committed to conducting clinical research and business operations with uncompromising integrity. Our work touches human lives, and every decision we make reflects our responsibility to protect participants, serve science, support our partners, and uphold the trust placed in us by sponsors, vendors investigators, regulators, ethics committees, participants and communities.
This Code of Ethics outlines the principles that guide all our activities and defines the standards of behavior expected from everyone who represents CliniRx.
1. Purpose of the Code
This Code establishes the ethical foundation for how we plan, conduct, monitor, analyze, and report clinical research and manage all associated business operations. It reflects international ethical norms and ensures that all CliniRx activities are carried out with professionalism, respect, and scientific rigor.
2. Who Must Follow This Code
This Code applies to:
- All CliniRx employees
- Contractors and consultants
- Third-party vendors, partners, and service providers acting on behalf of CliniRx
Compliance with this Code is a condition of engagement with our organization.
3. Our Guiding Ethical Principles
Our ethical responsibilities extend beyond research participants; they encompass how we treat our colleagues, partners, investigators, sponsors, vendors, regulators, and society at large. Every CliniRx representative is expected to act in accordance with the following principles:
3.1 Respect for Persons and Communities
We uphold the dignity, rights, and diversity of every individual we engage with; participants, investigators, employees, and community members. We maintain an inclusive, harassment-free, and respectful workplace and ensure informed, compassionate communication with all stakeholders.
3.2 Beneficence and Scientific Responsibility
We conduct and support research that advances science responsibly, maximizing potential benefits while minimizing harm. Patient safety, data quality, and public health interests take precedence over commercial or operational pressures.
3.3 Justice and Fairness
We ensure fairness in our professional dealings; equitable selection of research participants, impartial investigator engagement, transparent vendor selection, and merit-based employee opportunities. We oppose all forms of discrimination, bias, or exploitation.
3.4 Integrity and Honesty
We uphold truthfulness, accuracy, and accountability in all operations; from clinical data to financial records, from regulatory submissions to internal communications. Misrepresentation, falsification, or omission of facts is never acceptable.
3.5 Professional Independence and Objectivity
We maintain independence of professional judgment. Decisions are based on science, ethics, and regulatory standards; not personal interest or external influence.
We avoid conflicts of interest and disclose any situation that could compromise impartiality.
3.6 Transparency and Compliance
We communicate openly with sponsors, regulators, investigators, and partners, ensuring full, accurate, and timely disclosure of relevant information.
We comply with all applicable laws and standards, including those related to anti-bribery, data protection, labor practices, and environmental stewardship.
3.7 Accountability and Stewardship
We recognize our responsibility as stewards of entrusted resources; human, financial, and informational. We use company and client resources responsibly, maintain confidentiality, and protect proprietary and personal data.
3.8 Respect for the Environment and Society
CliniRx recognizes that responsible research and business operations must respect both the environment and the communities we serve. We are committed to sustainable practices that protect natural resources, promote safe and healthy workplaces, and contribute positively to society.
We will:
- Operate our offices, and trial-related activities in an environmentally responsible manner, striving to reduce waste, conserve energy and water, and minimize our carbon footprint.
- Ensure that all work environments are safe, healthy, and compliant with applicable environmental, occupational-health, and safety standards.
- Promote diversity, inclusion, and fairness in our workforce and with all external partners.
- Encourage suppliers and collaborators to adopt similar environmental and social responsibility standards.
- Support community development, education, and healthcare initiatives that align with our mission and values.
- Continuously review and improve our sustainability performance as part of our quality and compliance systems.
Through these commitments, CliniRx aims not only to meet regulatory expectations wherever we operate but also to uphold a broader ethical responsibility toward people, the planet, and future generations.
4. Regulatory and Ethical Compliance
CliniRx adheres to globally recognized ethical and regulatory frameworks, including:
- International Council for Harmonisation – Good Clinical Practice (ICH-GCP).
- The Declaration of Helsinki.
- All applicable national and international clinical research laws and regulations.
Compliance is not optional; it is integral to who we are.
5. Informed Consent
CliniRx ensures that:
- Informed consent is obtained freely and without coercion.
- Participants or their legally authorized representatives receive clear, accurate, and understandable information.
- Consent is appropriately documented and updated when new information emerges.
We honor the participant’s right to choose at all times.
6. Confidentiality and Data Protection
We protect personal data with the highest level of care and comply with all relevant data protection laws, including the EU GDPR, UK GDPR, and applicable local privacy regulations.
Participant, investigator, sponsor, vendor, and employee information is accessed strictly on a need-to-know basis and processed in accordance with our Data Protection and Privacy Policies.
7. Scientific and Data Integrity
CliniRx upholds uncompromising standards in scientific conduct and documentation:
- Data must be collected, processed, analyzed, and reported with accuracy and transparency.
- Any fabrication, falsification, or misrepresentation of data is strictly prohibited.
- Study records must be complete, contemporaneous, traceable, and verifiable.
- All staff are expected to follow Good Documentation Practice (GDP) principles in every aspect of data creation and maintenance.
We safeguard the reliability of every scientific conclusion drawn from the work we support.
8. Conflicts of Interest
All employees, consultants, and partners must identify and disclose:
- Any personal or financial interests that could influence professional judgment.
- Any relationship that could appear to compromise impartiality.
CliniRx implements measures to eliminate or appropriately manage such conflicts in alignment with applicable laws and company policy.
9. Training and Competency
We ensure that all relevant team members receive:
- Regular Good Clinical Practice (GCP) and ethics training.
- Role-appropriate technical and regulatory training.
- Ongoing competency assessments.
Training records are maintained and reviewed as part of our quality system.
10. Reporting Concerns and Whistleblower Protection
CliniRx encourages everyone to report suspected ethical, scientific, or regulatory violations/issues. Reports may be made confidentially and without fear of retaliation.
All concerns are investigated promptly, fairly, and objectively, and corrective or preventive measures are implemented where appropriate.
11. Commitment to Continuous Improvement
We reinforce ethical conduct through:
- Routine internal audits.
- Quality reviews.
- Periodic updates to procedures, training, and systems.
Ethical excellence is part of our continuous improvement journey.
12. Our Promise
CliniRx’s mission is rooted in trust; the trust of patients who volunteer for research, the trust of our sponsors, and the trust of regulators who oversee clinical development.
This Code of Ethics reflects our commitment to honor that trust in every study, every interaction, and every decision.
13. Amendment Clause
This Code of Ethics may be amended or updated from time to time to reflect evolving ethical standards, regulatory requirements, and organizational practices. The latest version will always be published on the official CliniRx website and shall supersede all previous versions. Employees and partners will be notified of significant revisions and are expected to familiarize themselves with the most current version.