A clinical research associate, otherwise known as a CRA, is a person whose job it is to ensure the success and smooth running of a clinical trial. As you probably already know, a clinical trial is the research process of proving that a certain medical treatment is safe and effective for human use. The trial involves carrying out a series of relevant tests to help determine these answers.
Once the trial has been completed, the results are used as an important and crucial part of the 510(k) clearance submission to be forwarded to the FDA. The clinical trial team will require an experienced CRA with experience in the associated area of study in order to effectively manage clinical data.
Importance of Controlled Trials
Clinical trials are essential if you want the associated new medical device or treatment to be cleared and approved by the FDA. Without FDA approval, your new treatment will never see the light of day in terms of marketing and human use etc.
Randomised controlled trials give medical researchers a unique and important way in which to determine the effectiveness of new treatments, helping them to decipher which of these treatments work and which fail to meet expectations.
Volunteers are needed to participate in these trials. Usually, the group involved are split up and one group receives the new treatment and the other will receive either a standard treatment or a placebo. This allows researchers to control the trial more efficiently, enabling them to compare the treatment as necessary with other existing treatments etc.
A major part of this process involves finding the right clinical research associate. So, how can you tell who is qualified and who isn’t?
CRA Credentials and Skills
Most researchers turn to clinical solution providers such as http://www.gandlscientific.com when searching for experienced and qualified Clinical Trial Associates. The most important roles of this member of staff includes, but is not limited, to the following:
- Trial protocol write-ups and development
- Trained in ICH/GCP guidelines
- CRF design experience and expertise
- Presentation of trail protocols to steering committees
- Management of regulatory authority approvals and applications
- Reviewing competitive landscapes and identifying other clinical trials as necessary
- Identifying and selecting appropriate investigators
- Preparing trial sites, final reports and manuscripts
- Identify any issues affecting recruitment, execution or patient retention