Are clinical trials safe? Clinical trial safety standards are strictly enforced to protect participants in medical research. Every study follows a rigid protocol monitored by regulatory agencies like the FDA and independent Institutional Review Boards (IRB) to minimize risks and ensure continuous medical supervision.

Celerion’s utmost concern is for the safety and well being of participants in clinical studies under our management and care. To ensure this commitment, Celerion takes numerous steps to maintain the safety of all clinical trial and research study participants. If you have more questions or concerns about Clinical Trials or about what we do here at Celerion, please make sure to Contact Us. 

The Protocol for Participant Safety in Medical Research

Celerion goes to great lengths to limit the risks associated with participating in medical research by taking the steps outlined below:

• Once a new medicine (investigational drug) has been discovered, the pharmaceutical or biotechnology company submits an application for their clinical study to the country’s regulatory agency for review. In the United States it is the Food and Drug Administration (FDA) and in the United Kingdom it is the Medical Healthcare and Products Regulatory Agency (MHRA). The regulatory agency then reviews the application for clinical research to assure the safety and rights of the participants is adequate.
  
  
• Once it has been determined that the application contains the necessary information, and a clinical study has been deemed safe, it may be conducted. The study then undergoes full review by an Institutional Review Board (IRB) or a Research Ethics Committee (REC) to ensure it is being conducted in a manner that protects the rights and welfare of participants. The IRB/REC is made up of individuals not associated with Celerion. The group includes both medical and non-medical professionals.
  
  
• Celerion’s physicians and scientists also review each study to ensure participant safety for the clinical trials. Our physicians have extensive experience in clinical research and have diverse medical backgrounds.
  
  
• Prior to taking part in the study, each study participant is given an Informed Consent Form (ICF). The ICF includes the name of the pharmaceutical or biotechnology company sponsoring the research, information about the medication being tested, potential side effects, and the expected payment for study participation. After reading the ICF, participants will meet with a Celerion representative to review the information. During that time, study procedures are explained and participants are encouraged to ask questions.
  
  
• Participants are required to provide a detailed explanation of their medical history and undergo a complete physical examination including laboratory work, prior to enrolling in a study. For participant safety in the upcoming clinic study, information regarding all prescription medicines, nonprescription medicines and dietary supplements being used must be provided. The medical information is reviewed by the study physician to ensure that only qualified, healthy participants are enrolled in a study.
  
  
• Each study is conducted under complete medical supervision with qualified medical professionals available at all times. Our physicians oversee all studies and are supported by on-site nursing staff that are available 24-hours a day. If a side-effect does occur, a medical professional will assist the participant. All side-effects are followed until resolution is complete.

Frequently Asked Questions About Clinical Trial Safety

What regulations ensure the safety of clinical trials?

Celerion follows strict clinical trial safety guidelines. Every study undergoes a comprehensive review by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States or the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, alongside independent Institutional Review Boards (IRB).

How is participant safety monitored during a study?

Each study is conducted under complete medical supervision by qualified medical professionals. Celerion's physicians and scientists oversee all studies, supported by an on-site nursing staff available 24 hours a day to follow up on any side effects until resolution is complete.