The success of clinical trials usually depend on the accurate creation, gathering, and analysis of the available data. There are high stakeholders involved in these trials like medical device manufacturers, biologics, pharmaceutical companies, and many other life sciences firms, so it makes sense to use clinical data management solutions to make sure the quality of the data from clinical trials is good.
Besides, clinical data management solutions can also assist life science organizations to protect and secure patient records and even the data for the clinical trial participants. This post will discuss the importance of having good clinical data management.
Understanding clinical data management
Clinical data management refers to what it offers the organizations, which are high-quality data and outcomes. Well, clinical data management can provide answers to most research questions and conclusions based on hypotheses using data. If offers results by creating a database that is considered valid, statistically good, and error-free. In short, clinical data management has a three-step process, which is collection, cleaning, and management of data.
The two major objectives of clinical data management are to collect enough data for analysis and to make sure that this data is of high-quality and integrity. This data can be utilized for statistical analysis by reducing errors and cases of missing data. The clinical data management process needs to follow strict regulatory requirements that must be complied by life sciences organizations.
There are millions of cases involving medical data security breaches around the world. Hackers and criminals now know that sensitive personal information or medical data are considered to be more useful than credit card data. After all, medical information is regarded to be more expensive than credit card data, though it’s easier for hackers to access it.
Besides, you can cancel and replace a credit card while medical data is permanent. As a result, this gives criminals and hackers enough time to use medical information to commit fraud. Aside from this, they can use medical data to create fake IDs and even forge documents. They can then use these to buy expensive medical devices and file for insurance claims.
Life science organizations usually use the sensitive personal health information in the clinical trials, so they need to make security a top priority to protect insurance companies from fraudulent claims, patients’ medical data, and preserve the trust they have from the public.
Also, life sciences firms like medical device manufacturers, pharmaceutical companies, biotech companies, and biologics developers need to secure their clinical data so that they can comply with regulations that were established by government agencies. There are many agencies out there including the United States Food and Drug Administration that regulate clinical data.
For example, the United States Food and Drug Administration required life sciences firms to implement the right controls over their electronic signatures and electronic records. In this way, there can be authenticity, integrity, and confidentiality of clinical data. Keep in mind that these controls include limiting access to your systems so that only authorized people can have access, systems validation, and using computerized and secure audit trails.
The benefits of clinical data management
Besides the above controls, it’s worth noting that life sciences firms are also covered by rigorous security and privacy requirements of the HIPAA. HIPAA needs organizations including life sciences firms to establish physical, administrative, and technical protection for the clinical data like the Electronic Protected Health Information they keep in their systems.
This protection includes establishing data privacy policies, designating a privacy officer, having written privacy procedures, authenticating companies with which you disclose information, and restricting system access.
From a business perspective, it’s important to get in touch with life science consulting companies so that you can secure clinical data as it gives you a competitive advantage. Remember that life sciences firms spend tons of money to research, develop, test new medical devices and drugs.
The results of this research, development as well as testing are stored in the clinical trial records. Therefore, if your competitors were to get their hands on the clinical trial records, they may duplicate your company’s efforts at a lower cost and even be the first to take the new medical device or drug on the market.
That said, the first step you can take to secure clinical data is to make sure that the critical information is all accounted for. Clinical data management solutions do this by helping life sciences firms to get better visibility on their clinical data. These solutions allow large volumes of trial data and even research documents from various sources like social sources, electronic health records, research partners, and many more to be easily accessed, visible, uncovered, verified, and protected.
Clinical data management solutions can also do data analytics on large amounts of data. Data analytics enables life sciences firms to process information to make it easy for integration on applications and gather the information for ease of use and consistency. This can empower life sciences companies to easily use security measures when there is dissimilar data.
Recently, the clinical data management solutions are increasingly being adopted by various life sciences companies, especially pharmaceutical companies. These large companies that it’s important to maintain large clinical data as well as other medical information. So clinical data information comes in handy as it can handle complex trials and make sure that data integrity and quality are maintained despite huge data volumes.
Even better, clinical data solutions make sure that there is timely and accurate clinical data that needs to be generated and analyzed. This tends to accelerate the decision making process.
Therefore, clinical data management is known for streamlining various data management processes like case report form tracking and filing, data collection, data entry, and even data validation. Hence, all these across-the-board improvements may cause faster development, testing, and faster-time-to-market of drugs and medical devices.
As explained before, clinical research and the use of large amounts of patients’ data for clinical trials attracts stringent regulatory requirements. Also, globalization of these clinical trials done by pharmaceutical and life sciences companies means that you have to establish stricter safeguards and higher standards.