Drug or treatment discovery is an extremely long, expensive, and complicated process. This form of discovery requires identification of treatment or drug compounds and screening for therapeutic safety and efficiency. Clinical research trials are research studies that explore a new drug or treatment in detail to determine their safety profile. Clinical data management (CDM) is a methodology of handling the data acquired during the clinical research trial. This data is one of the most valuable data forms for any sponsored research and pharmaceutical product manufactures. CDM is a critical phase of any trial. This phase leads to the production of high-quality data that is extremely reliable and statistically accurate. Learn More: clinical research training
In today's world, clinical research is almost impossible without an efficient clinical data management. The CDM is solely responsible for handling the increasing data acquired from the clinical trials. Conventional forms of data recording included writing them up on sheets in the form of reports. However, modern methods use electronic data capture systems (EDCs) for data entry. Data entry and data assessment processes are moving toward automation and software to develop technology to obtain more accurate results and reliable data records. EDCs are extremely popular as they are quicker and more reliable to access data in random order.
Importance of securing Clinical Data
A large amount of data security breaches are recorded every day. Most criminals and hackers now recognize sensitive personal health information and medical data as more valuable than the monetary data. As credit cards and monetary data can easily be replaced or canceled, an individual's medical data is personal and irreplaceable. It gives these hackers an edge to use this sensitive data to commit fraud. Medical data can also be used to fabricate fake IDs and documents, which can claim insurance and illegally buy drugs and other medications.
As CROs use this form of personal and sensitive data, they must secure their data to ensure that it does not get into the wrong hands. CROs have to comply with the regulations set by the concerned authorities and the government. These authorities implement control regulations on the electronic records of data to ensure their authority, integrity, authenticity, and confidentiality of this clinical data acquired through the clinical research trials. These controls mainly include limiting the access of these records to authorized individuals only, system validation, and the use of secure and computerized audit trials. Know More About: Clinical Research Courses
How does clinical data management (CDM) secure data?
The initial step in securing clinical data is making sure that all the vital information is accounted for. CDM processes accomplish this by allowing clinical research organizations to better understand their clinical data. CDM solutions also allow the large trial data and research studies documents from various sources such as EDCs in social sources, information systems, and public health data to be visible, and research partners, which are easily accessed and verified. Therefore, the data acquired by the clinical research trials protected through CDM.