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Schrödinger Policy on Clinical Trial Transparency & Protection of Clinical Trial Participants

I. Purpose

Schrödinger is dedicated to advancing science and improving patient outcomes through innovative drug discovery and development. We acknowledge the critical importance of transparency in clinical trials, ethical practices, and the protection of human rights, including informed consent and participant data protection. Schrödinger’s Policy on Clinical Trial Transparency and Subject Protection outlines our commitment to publicly posting ongoing clinical trials, sharing trial results, and adhering to best practices, regulatory requirements, and the principles of human rights in the context of human subject protection.

II. Scope

This policy applies to all clinical trials conducted or sponsored by Schrödinger, whether initiated internally or in collaboration with external partners, and regardless of geographic location. Furthermore, this policy applies to the Schrödinger Clinical Development Organization, including internal and external stakeholders, who are involved in the conduct and execution of Schrödinger’s clinical trials.

III. Policy

Ongoing Clinical Trials Transparency: Schrödinger ensures that all applicable clinical trials are registered on publicly accessible clinical trial registries, such as ClinicalTrials.gov, the European Clinical Trials Database (EudraCT), or other relevant platforms, in strict accordance with regional regulations and international standards. These registrations will include timely updates of trial information.

Clinical Trial Results Transparency: Schrödinger is committed to timely and comprehensive posting of completed clinical trial results in accordance with applicable regulations and industry standards. We disclose results for all interventional trials, regardless of whether they were successful, inconclusive, or negative. In addition to sharing results on publicly accessible platforms, Schrödinger facilitates data sharing for further research and scientific advancement by encouraging the publication of research findings in peer-reviewed journals.

Protection of Clinical Trial Participants and Their Data:
Schrödinger adheres to the highest standards of best practices and regulatory requirements for protecting the safety and ethics of anyone participating in Schrödinger sponsored clinical trials. This includes informed consent of trial participants that provides clear and understandable information about the trial’s purpose, risks, benefits, and alternatives to participation, while respecting the principles of human rights, including the right to autonomy, dignity, and protection from harm. All trial protocols involving human participants undergo review by an institutional review and/or ethics committee where the informed consent documents are thoroughly reviewed to ensure compliance with ethical principles, human rights standards, and regulatory guidelines. Furthermore, Schrödinger commits to comply with laws guiding data privacy in the jurisdiction in which we operate.

Compliance, Improvement and Oversight:
Schrödinger strictly adheres to all applicable local, national, and international regulations and guidelines related to clinical trial transparency and the protection of participants enrolled into clinical trials. Schrödinger is committed to continuously improving our clinical trial transparency practices and participant protection, including informed consent procedures, in accordance with evolving regulatory requirements, best practices, and human rights principles. The Chief Medical Officer (CMO) and the Clinical Development Team oversee the implementation of this policy and ensure that all employees and contractors involved in the conduct of Schrödinger clinical trials are aware of and adhere to these principles. Furthermore, Schrödinger provides regular updates on our transparency efforts, informed consent practices, and human rights commitments in Schrödinger’s annual reports, including the number of clinical trials registered, the status of results reporting, and any challenges encountered.