Kyntra Bio Global Code of Ethics for Clinical Trials
Kyntra Bio’s mission is to improve the lives of people globally by developing innovative therapies anchored in high-quality science and our passion for patients. We treat patient safety as a top priority and hold ourselves accountable to the highest ethical principles and standards in our clinical trials, whether independently or in collaboration with partners, contract research organizations, or other third parties. All Kyntra Bio-sponsored clinical trials are conducted in accordance with the applicable regulations, Health Authority standards, and Good Clinical Practice (GCP) guidelines. Kyntra Bio maintains internal procedures to ensure compliance with the applicable clinical trial standards as it pertains to:
Appropriateness
All research should be designed to address a legitimate scientific question or need.
Selection of Investigators
Kyntra Bio selects clinical investigators who possess the necessary qualifications, training, research, and clinical expertise, as well as the potential to recruit research participants. The independence of clinical investigators and others involved in clinical research is critical to protect the best interest of research participants. Kyntra Bio does not engage any clinical investigators who have been debarred, disqualified, or restricted from participating in clinical research.
Ethical Review
Kyntra Bio-sponsored trials undergo an ethical review by a qualified independent committee (Institutional Review Board/Independent Ethics Committee) prior to study initiation.
Privacy
Kyntra Bio is committed to protecting patients’ privacy, collecting minimal subject identifiers, and complying with all applicable privacy laws and regulations.
Integrity of Clinical Data
Kyntra Bio ensures data are reliable, processed accurately, and reported in accordance with established data integrity standards.
Informed Consent
Kyntra Bio requires voluntary informed consent from all research participants. Consent materials outline known benefits and risks of the trial, and additional safeguards are implemented to protect minors.
Safety Monitoring
Kyntra Bio monitors patient safety throughout the duration of clinical trials, including long-term follow-up when appropriate. Adverse event information is collected, processed, reported, analyzed, and communicated in a timely manner. Clinical investigators are expected to report adverse events and provide timely updates to participants and others, as appropriate.
Compensation
We ensure that any payments, injury compensation, and other benefits provided to research participants are appropriate and do not unduly influence their decision to participate in a clinical research study. Investigator payments are based on services rendered and must align with Fair Market Value (FMV) and Kyntra Bio’s HCP/FMV policy, as well as local regulations.
Investigator Meetings
Kyntra Bio ensures that investigator meetings are modest in location and cost for the purpose of training study staff on participating in a Kyntra Bio clinical trial. Investigators are not paid for their time, but Kyntra Bio provides reasonable accommodations in compliance with Kyntra Bio’s HCP/FMV policy and local country requirements.
Transparency
Kyntra Bio publicly discloses information about its clinical trials in compliance with the applicable regulations, Health Authority standards, and GCP guidelines. We are also committed to publishing clinical trial results, regardless of outcome or regulatory approval.
Diversity
Kyntra Bio strives to conduct clinical trials without bias. We are committed to identifying and reducing the potential barriers to clinical trial access and participation. We strive to improve subject recruitment, enrollment, and retention processes to ensure disease-appropriate subject representation and greater inclusion of patients across racial, ethnic, gender, age, and socioeconomic groups.