Importance of Patient Safety
At Équilibre Biopharmaceuticals Corp., we view patients as our primary focus. We strive to understand their unique journeys and individual needs. The benefit of patients and their families is our inspiration. As such, the safety of patients is focal to our work.
We are committed to complete and timely evaluation of the benefits and risks of our therapies, and communicating this and other educational information to help healthcare professionals and patients make informed treatment choices.
Our investigational therapies are subject to rigorous testing. Before a medicine is initially given to patients, our findings from pre-clinical studies (before entry into humans) are carefully analyzed and discussed with regulatory authorities. The medicine then undergoes a long process of investigation using well-designed clinical trials to help determine the safety and efficacy of the investigational therapy.
During clinical trials, we collect information regarding side effects and health problems (also known as “adverse events”) and other safety information from patients, caregivers and healthcare professionals, among others, on an ongoing basis. Our employees and those who support us undergo training on what an adverse event is, how to recognize one and how to report adverse events. To report an adverse event or a product complaint click here and complete the submission form, or contact us by calling +1 332-400-0300.
Our pharmacovigilance and medical affairs teams review adverse events and safety information received for our investigational therapies and determines what actions, if any, may need to be taken with regard to any potential evolving safety profile of our therapies.
As a biotechnology company researching new neurological therapies, it is our responsibility to keep patient safety at the core of our mission to create a world where no life is limited by neurodegenerative diseases.
For information or inquiries about our clinical trial programs, please contact us as email@example.com.
Équilibre Biopharmaceuticals Corp. is committed to expeditiously developing safe and effective therapies to transform the lives of patients with neurodegenerative diseases. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.
Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. Expanded Access is different from a clinical trial, where more comprehensive safety and efficacy data are collected. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.
Équilibre Biopharmaceuticals Corp. is a biopharmaceutical company committed to discovering and developing novel treatments for patients. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug.
Requests should be submitted by the treating licensed physician and should include sufficient supporting detail to enable Équilibre to evaluate the expanded access request. Please include contact information so that Équilibre can follow-up with the physician directly (i.e., address, phone number, e-mail).
Requests for expanded access need to be made by the physician responsible for treating the patient, and each request needs to relate to a single patient. Submit sufficient supporting detail to enable Équilibre to evaluate the expanded access request. The requesting physician would be expected to submit an Investigator IND, if appropriate, after Équilibre reviews all provided information. Équilibre could provide the investigational drug necessary to support single-person expanded access if such provision does not hinder Équilibre’s on-going clinical trials.
Équilibre will endeavor to acknowledge receipt of any expanded access questions or requests within 5-10 business days of receipt.
A treating physician may submit questions or requests regarding expanded access to the following: firstname.lastname@example.org.
Additional information may be obtained from the U.S. Food and Drug Administration at www.fda.gov.
This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.
As authorized by the 21st Century Cures Act, Équilibre may revise this expanded access policy at any time. Additionally, the posting of the policy by Équilibre shall not serve as a guarantee of access to any specific investigational drug for any patient. patients make informed treatment choices.