Element Technologies

Clinical data management (CDM) is the process of collecting and managing research data following regulatory standards to obtain complete and error-free quality information. Keeping federal, state, and local regulations in mind, the goal is to collect as much data as possible for analysis.

 

Clinical data management (CDM) emerged because of demands from both the pharmaceutical industry and regulatory authorities. As the pressure to “speed up” the development of pharmaceutical products grows, regulatory bodies have responded by requiring quality-assurance standards to be met when collecting data for the drug evaluation process.

 

Why is clinical data management important?

 

From an ethical standpoint, drug developers want to ensure that the data delivered to regulatory bodies is reliable; clinical data inform treatment decisions and, ultimately, patient health. Clinical data quality and integrity are crucial for both of these reasons. Although it may seem that data management begins only after the data is collected, the process actually starts before the study protocol is finalized.

 

In a pharmaceutical company, CDM is one of the most important and valuable assets. Throughout the medical research life cycle, massive amounts of data are collected. The CDM process follows a well-defined structure and system to prevent huge financial loss or valuable resources. The data authentication and catalog process can be validated at each stage to avoid irreparable errors. 

 

Pharmacovigilance (PV) is “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.”

 

Pharmacovigilance begins with clinical trials, which provide information about a drug’s benefits and risks. In clinical research, pharmacovigilance aims to analyze whether the benefits outweigh the risks; if they do, drug manufacturers take steps to gain approval to market the new drug.

 

Why is Pharmacovigilance important?

 

While it may seem obvious that drugs should be thoroughly tested and monitored for safety, the process was not formalized until the 1960s, after the infamous thalidomide incident. Thalidomide was introduced in 1957 as a sedative for sleeplessness and was deemed safe for pregnant women to use. Because the drug helped relieve morning sickness, it quickly gained popularity among expectant mothers.

 

Fast forward to 1962, and the drug’s true effects were revealed. It was discovered to be a teratogen, causing deformities in thousands of children. Therefore, new stringent testing laws were introduced, giving rise to what is now known as pharmacovigilance.

 

PV is important during the clinical research phase of drug development to ensure the drug is safe for distribution. Still, it is also important to monitor the drug continuously. Post-market safety monitoring is the only way to get a complete picture of a drug’s safety and ensure that adverse events are properly reported for review, such as through the FDA’s MedWatch portal.

 

Which is better clinical data management or Pharmacovigilance?

 

PV is nearing saturation with many Pharma companies making decisions because pharmacovigilance is an expense rather than an investment for Pharma companies. No one wants to invest because there aren’t many profits from Pharmacovigilance activities for pharma companies. 

 

On the other hand, clinical Data Management is an investment (as part of clinical trials) with much higher profits than Pharmacovigilance (which may be indirect). Many IT firms are taking on clinical data management projects, which will create more opportunities and vacancies.

 

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