Clinical Research
Driven by science,
inspired by patients
Guided by physicians at clinical sites worldwide
We conduct vigorous and streamlined clinical studies, forging new paths of knowledge and shaping the future of healthcare. Learn more about our clinical research program, gain insights, and explore our completed trials, ongoing studies, and postmarketing commitments.
Clinical Trials & Results
We support transparent and responsible scientific disclosure. Endo registers all applicable clinical trials on clinicaltrials.gov, provides status updates, and shares study results.
Following the completion of a clinical trial, we disclose relevant study results through scientific publications.
Find information and results for completed and ongoing studies at clinicaltrials.gov or follow the links in the studies sections linked below.
For inquiries about our ongoing clinical trials, please contact us at clinicaltrials@endo.com.
Clinical Trial Conduct
We run studies with a dedication to the highest quality and safety standards at the core. Our clinical studies are performed in compliance with current Good Clinical Practices, including the ICH E6 guidance. In addition, the Endo Generics business unit follows all applicable regulations for generic drug development issued by the Office of Generics (OGD).
Key elements of our process include:
Training
All R&D team members go through robust annual training aligned with the ICH E6 Good Clinical Practice training and Good Manufacturing Practice Compliance training, as well as Endo’s Standard Operating Procedure on the Protection of Human Subjects: Ethics and Advertising Approvals.
Oversight
All phase 1-4 clinical study protocols are reviewed and approved by an established internal committee called the Protocol Approval Committee. This cross-functional team evaluates protocol concepts/synopses to determine scientific merit and approvability and assesses the ethical implications of the study.
Risk-Based Management
Our Risk Assessment and Management process begins at the planning stage and extends through the execution of clinical studies. Through this process, we identify all potential risks and establish a plan to manage them.
Patient Protections
Our standard operating procedures require that we follow all applicable regulations around vulnerable participants, including but not limited to children, prisoners, and pregnant women. All trials follow applicable privacy laws and regulations to maintain patient privacy.
Proactive Quality Management
We employ Quality by Design (QbD) principles 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 that arise.
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 of 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, system, investigator, and regulatory audits. We audit our clinical trial sites throughout the course of studies using a risk-based approach and use standard monitoring processes. All applicable vendors used in the clinical trial process are audited prior to the start of their work to support our clinical trials.
Pre-Clinical Work
We approach the use of animals with humane and ethical concern. Our R&D efforts are primarily focused on phases 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, Endo aims to limit animal testing. Alternatives are used whenever they are scientifically valid and acceptable to regulators. Endo only contracts with companies with bioethical standards in line with our own policies.
Postmarketing Commitments & Requirements
Postmarketing commitments (PMCs) and requirements (PMRs) refer to studies and clinical trials that sponsors conduct after FDA approval to gather additional information about a product's safety, efficacy, or optimal use. Some studies and clinical trials may be required by the FDA, and others may be necessary because of our commitment to conduct ongoing research. Additional information about these studies can be found on the FDA website.
