When your business or practice is running clinical trials, quality assurance for patient safety is critical. Life sciences consulting experts are able to observe how your clinic runs its trials and make suggestions on how to improve processes and conditions in your facility. Consider these three ways in which the health sciences auditing process can help your clinical trial’s safety record.
Improving Your Quality Assurance
Consulting firms can come in at any time to check out your quality assurance program. The quality assurance setup for your trial may not cover everything that the auditors or regulatory experts think it should. The consulting firms can help you to set up helpful databases and make recommendations about what to track. They can also offer tips on ensuring that human errors are minimized by implementing a checking system for verification before any patient receives a medication or medical intervention.
Early Identification of Concerns
Sometimes in a trial for a new medication or new use of a medication or medical device, patients may begin to report side effects, new symptoms or a worsening of their conditions. With a life sciences consulting firm, issues such as toxicology will be brought to the forefront. These regulatory experts can review toxicology results and make recommendations about whether or not a certain participant should stop using the medication or if the person should halt treatment and drop out of the trial. The auditing might also find that certain types of toxicology results are missing from laboratory reports. Insufficient data is a common problem that plagues the health sciences and medical research. The auditing team may recommend that more tests be added in order to identify potential areas of concern.
Implementing Safety Recommendations
Clinical trials require strict safeguards and privacy guidelines to protect participants from harm. If the auditors and regulation experts discover any issues, they will write them up and provide your clinic with recommendations on how to make the situation safer for the participants. For example, the auditors may discover that a certain drug being tested in a clinical trial tends to cause sleepiness in people who take it. They may recommend that you tell participants in the trial to avoid driving or operating heavy machinery for a specific period of time after taking the medication. This keeps participants safe. It also allows the trial to continue progressing with a lesser risk of unintended injury or other consequences on the participants.