The success of any clinical trial depends on the accurate generation, gathering, and analysis of data. Because of the high stakes involved, pharmaceutical companies, medical device manufacturers, biologics, and other life sciences organizations turn to Clinical Data Management (CDM) solutions to ensure the quality of their data. At the same time, CDM solutions also help life sciences organizations secure and protect patient records and clinical trial participants’ data.
However, what exactly is CDM? Why is securing clinical data through CDM important for life sciences organizations? What are its benefits?
A Closer Look at CDM
CDM is defined by what it delivers for organizations: quality data and outcomes. It delivers answers to research questions and conclusions to hypotheses using data. It delivers results by building a database that is valid, statistically sound, and error-free.
CDM involves a three-step process:
Management of data.
The CDM process’ two main objectives are to gather the maximum amount of data for analysis and to ensure that the data is of the highest quality and integrity for statistical analysis by minimizing errors and instances of missing data. Throughout the entire CDM process, it is also important to keep in mind the strict regulatory requirements that life sciences organizations have to comply with.
The Importance of Securing Clinical Data
In the U.S. alone, 11 million cases of medical data security breaches were recorded in 2015. Criminals and hackers now recognize that medical data or sensitive personal health information (PHI) are more valuable than credit card data. In fact, medical information is considered to be ten times more expensive than credit card data, yet is 100 times easier for hackers to get their hands on.
While credit cards can easily be canceled and replaced, medical data is permanent. This gives criminals more time to use medical data to commit fraud. At the same time, medical data can be used to create fake IDs and forge documents that can then be used to file for expensive insurance claims and illegally buy drugs and medical devices.
Since life sciences organizations often use these sensitive personal health information in their clinical trials, they are required to make security a top priority to safeguard their patients’ medical data, protect insurance companies against fraudulent claims, and preserve the public’s trust in the life sciences industry.
It is also important for life sciences organizations such as pharmaceutical companies, medical device manufacturers, biologics developers, and biotech companies to secure their clinical data to comply with regulations established by government agencies. One of these agencies is the United States Food and Drug Administration (US FDA). Part 11 of Title 21 of the Code of Federal Regulations (commonly known as 21 CFR Part 11) established by the U.S. FDA requires life sciences organizations to implement controls over their electronic records and electronic signatures (ERES) to ensure the integrity, authenticity, and confidentiality of clinical data. These controls include systems validation, limiting access to systems to authorized individuals, and using secure and computerized audit trails.
Life sciences organizations are also covered by the stringent privacy and security requirements of the Health Insurance Portability and Accountability Act (HIPAA). HIPAA requires entities including life sciences organizations to establish administrative, physical, and technical safeguards for their clinical data such as the Electronic Protected Health Information (EPHI) they store in their systems. These safeguards include establishing data privacy policies, adopting written privacy procedures, designating a privacy officer, restricting system access, and authenticating entities with which they disclose information.
From a business perspective, securing clinical data is important for maintaining a competitive advantage. Life sciences organizations spend millions of dollars to research, develop, and test new drugs and medical devices. The results of their research, development, and testing are kept in their clinical trial records. If competitors get their hands on these clinical trial records, they can easily duplicate the organization’s efforts at a much lower cost and potentially be the first to market the new drug or medical device.
How CDM Secures Clinical Data
The first step to securing clinical data is ensuring that all critical information is accounted for. CDM solutions accomplish this by enabling life sciences organizations to obtain better visibility over their clinical data. CDM solutions allow voluminous trial data and research documents from disparate sources such as electronic health records in information systems, social sources, research partners, and public health data to be visible, easily accessed, discovered, verified, and thus protected.
CDM solutions are also capable of performing data analytics on massive amounts of data. Data analytics allow life sciences organizations to process dissimilar information for easy integration among applications and harmonize the information for consistency and ease of use. This empowers life sciences organizations to easily apply security measures for dissimilar data.
Other Benefits of CDM
In recent years, the adoption of CDM solutions and systems has been on the rise for life sciences companies, especially for multinational pharmaceutical corporations. With more massive clinical trial data and other medical information to maintain, CDM solutions are making it possible to handle complex trials and ensure data quality and integrity despite larger data volumes. In addition, CDM solutions are enabling life sciences organizations to reap other medical and business advantages such as the following.
Faster Time-to-Market and Commercialization
CDM solutions enable more accurate and timely clinical data to be generated and analyzed, thereby accelerating the decision-making process. CDM solutions also streamline different data management processes such as Data Collection, Case Report Form filing and tracking, Data Entry, and Data Validation. These across-the-board improvements lead to faster development, testing, and commercialization of drugs and medical devices.
Compliance With Global Regulatory Requirements
More clinical research and larger amounts of data mean complying with ever-increasing regulatory requirements of growing complexity. Furthermore, globalization of clinical trials performed by life sciences and pharmaceutical companies means international standards need to be met. This puts the onus on life sciences companies to establish higher standards and stricter safeguards.
A typical life sciences organization has to comply with standards from various local and international regulating bodies such as theSociety of Clinical Data Management (SCDM) which publishes the Good Clinical Data Management Practices (GCDMP) guidelines and the Clinical Data Interchange Standards Consortium (CDISC). Scalable CDM solutions enable life sciences organizations to keep track of regulatory requirements and ensure compliance in the midst of the increasing complexity of clinical trials and the exponentially increasing amounts of medical data.