Safety

Safety of study participants is our number one priority.  Due to this commitment, Celerion takes numerous steps to maintain the safety of study participants.  However, in doing 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:

Step One:  The Food and Drug Administration (FDA) must deem the study safe prior to Celerion conducting the study.

Step Two:  Once approved by the FDA, an Institutional Review Board (IRB) reviews the study for safety. Each study is evaluated to determine that it complies with international regulatory guidelines to ensure participant safety and well-being. The IRB is made up of members of the community not associated with Celerion. The group includes both medical and non-medical professionals.  

Step Three:  Celerion physicians and scientists review each study to ensure participant safety.  Our physicians have over 33 years of combined experience conducting clinical research.

Step Four:  Prior to study participation each participant is given a study specific Informed Consent Form (ICF) to read.  The ICF will include the name of the pharmaceutical company sponsoring the research, the medication name, the potential side effects, what measurements will be taken, and payment for study participation.  After the participant reads the ICF they will meet with a Celerion representative to review the information they have read.  During that time study procedures are explained and participants are encouraged to ask any questions they have regarding participation.

Step Five:  Participants are required to provide a detailed explanation of their medical history and undergo a complete physical examination including labwork prior to participation on a study.  For participant safety, it is essential that participants provide information regarding all prescription and nonprescription medicines and dietary supplements they are taking.  Each participant's medical information will be reviewed by the study physician to ensure that only qualified healthy participants are enrolled on a study.

Step Six:  Every study is conducted under complete medical supervision.  There is a qualified medical professional available at all times during a study.  If a side-effect does occur a medical professional will assist the participant. All side-effects are followed until resolution.