All Drug Trials are Identical

Clinical trials for drugs and vaccines are quite similar on the operational side but much different on the disease side. The goals for a vaccine trial are looking at certain things which are different from what a drug would do.

However, from an operational side, they are pretty much identical.

Professional clinical trials specialize based on the nuances of the disease. In cancer trials, technicians understand their patients and the physicians who work with those patients. But, when it comes to the operational side, the clinical trial processes look the same.

So, when technicians specialize in certain diseases, it means that they have done more trials in that particular disease. They can probably do trials in other diseases but they have more experience in the disease.

Additionally, clinical trials have certain standards to assure safety of the people participating in them. The core quality standards for clinical trials are described in “Good Clinical Practices” or GCP. Each country has their own rules, too. For example, the core competencies rules are similar to doing a trial in Israel. Israel also has some additional rules for clinical trials testing. Bottom line: Quality standards are international in nature and their intentions are all the same: protect trial subjects from harm.

Lastly, the best way to take advantage of the operational similarity across these clinical trials is to do it the same way and follow the same standards in the same sequence by making it automated. Most clinical trial operations are routine.  Technicians should not be required to remember and try to solve the problem every single time.

Using standardized systems through automation, will reduce what it takes to start a trial and execute it. It also reduces errors. There is no need to reinvent the wheel every time.

DLTA, Drug Lifecycle Tracking Application maps the end-to-end drug approval process. It offers a one stop shop to manage Drug Lifecycle and Regulatory Review process. The application includes built-in tasks, durations, dependencies, key milestones and forms to capture relevant meta-data for each step. And DLTA also provides reports to show complete visibility of all drug approval tasks, their priorities and progress. For more information call (240) 753-8282 or email info@druglifecycle.com.

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