Clinical Trial Conduct
Endo is committed to running studies with the highest quality. Our clinical studies are performed in compliance with current Good Clinical Practices, including the ICH E6 R2 guidance. In addition, the Endo Generics Division follows all applicable regulations for generic drug development issued by Office of Generics (OGD).
Key elements of our process include:
| Training |
All R&D team members go through robust annual training aligned to the ICH E6 Good Clinical Practice training as well as Good Manufacturing Practice Compliance training. The R&D team is also trained on the Company’s Standard Operating Procedure on the Protection of Human Subjects: Ethics and Advertising Approvals. |
| Oversight |
All clinical study protocols at Endo are reviewed and approved by an established internal committee called the Protocol Approval Committee (PAC). This committee is a cross-functional team that reviews and evaluates protocol concepts/synopses to determine scientific merit and approvability as well as accessing the ethical implications of the study. |
| Risk-Based Management |
Endo has implemented a Risk Assessment and Management process that begins at the planning stage and extends through the execution of clinical studies. All potential risks are identified and a plan to manage against them is established. |
| Patient Protections |
Standard operating procedures are in place to address vulnerable subjects, including but not limited to children, prisoners and pregnant women, which requires the Company to follow all applicable regulations around vulnerable participants. All trials also follow the Health Insurance Portability and Accountability Act regulations to maintain patient privacy. |
| Proactive Quality Management |
Quality by Design (QbD) principles are used when initiating and monitoring our clinical trials. A dedicated team plans and reviews the execution of all studies and works with the R&D Leadership Team to investigate and address any issues should they come up. |
| Electronic Systems & Documentation |
Electronic systems support the validation and quality control of all users, and track and document all data entries required over the course of any given trial, in support the ALCOA+C principles of quality documentation. ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate and Complete. |
| Auditing |
We have clear Standard Operating Procedures in place to support additional auditing efforts including vendor audits, system audits, investigator and regulatory audits. We work to audit our clinical trials sites throughout the course of studies using a risk-based approach and use standard monitoring processes as well. All applicable vendors used in the clinical trial process are audited prior to the start of their work to support our clinical trials. |
| Animal Welfare |
At Endo, we approach the use of animals with humane and ethical concern for those animals. Our R&D efforts are primarily focused on phase 1-3, as well as post-marketing studies and label extension studies. Therefore, our use of animals in research is limited. When pre-clinical work is required, the Company aims to limit animal testing. We always seek to replace animals if possible, reduce the numbers of animals used or refine procedures to minimize distress. Alternatives are used whenever they are scientifically valid and acceptable to regulators. Endo only contracts with companies with bioethical standards in line with Endo’s policies. Any animal study is also subject to approval through Endo’s own internal processes. |