Safety

The safety of our study participants is our number one priority.  To ensure this commitment, Celerion takes numerous steps to maintain the safety of all study participants.  

However, in completing medical research there is always a potential risk of an adverse reaction.  Celerion goes to great lengths to limit the risks associated with participating in medical research by taking the steps outlined below:

  1. Once an investigational drug or biological study has been proposed, the sponsor must submit an application to the Food and Drug Administration (FDA) for review.  If there is no apparent reason the proposed study should not be conducted, the investigational process will continue.
     
  2. After the application has undergone an initial review, an Institutional Review Board (IRB) or a Research Ethics Committee (REC) evaluates the study to ensure it is being conducted in a manner that protects the rights and welfare of participants.  The IRB/REC includes members of the community not associated with Celerion.  The group includes both medical and non-medical professionals.    
     
  3. Celerions' physicians and scientists review each study to ensure participant safety.  Our physicians have over 33 years of combined experience conducting clinical research.
     
  4. Prior to study participation each participant is given an Informed Consent Form (ICF).  The ICF includes the name of the pharmaceutical 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 any questions they have regarding participation.  
     
  5. Participants are required to provide a detailed explanation of their medical history and undergo a complete physical examination including lab work, prior to participation in a study.  For participant safety, it is essential that participants provide information regarding all prescription medicines, nonprescription medicines and dietary supplements being used.   Each participant's medical information is reviewed by the study physician to ensure that only qualified, healthy participants are enrolled in a study.  
     
  6. Every study is conducted under complete medical supervision and qualified medical professionals are available at all times.  If a side-effect does occur, a medical professional will assist the participant.  Side-effects are generally mild, for example a participant may experience a headache following the dosing of a study medication.  All side-effects are followed until resolution is complete.