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Exploring Paperless eClinical Solutions and How They Address Problems with Paper Data Collection
Paper data collection is known as a tried and tested method of collecting and handling information. However, its use poses a number of data security and integrity problems.
Regulatory standards, such as those established by HIPAA, require that individually identifiable health information is kept safe from unauthorized persons. But as pharmaceutical companies, Clinical Research Organizations (CROs), and medical device companies continue to collect and manage increasing amounts of clinical information, it becomes harder to keep them properly secure. This is especially the case with traditional physical documents that could easily be destroyed or seen by unauthorized persons.
As for maintaining data integrity, paper-based Case Report Forms (CRFs) can be difficult to record because of the complexity of the collection process. Discrepancies in the data may also affect the integrity of the research.
Another problem with using paper for data collection relates to how much it impacts the environment. Although more researchers today have adopted electronic mediums for their data, paper still remains as a popular primary tool. But due to the vast amount of data collected from clinical trials, a great amount of resources is used. There is also the issue of transporting this physical data, which also consumes more time and energy.
To address these problems, researchers can look at two options for a paperless eClinical solution:
Installed Electronic Data Capture (EDC) software provides a unified database that makes use of the company's own IT resources. Because the data is kept within their physical reach, it gives the company peace of mind. It also cuts down on the need for paper documents. Making a complete transition from paper-based data, however, can be daunting hurdle to overcome.
Because this software is all their own, companies may need to shell out a great expense for licensing and the ongoing maintenance fees. Researchers must also learn how to work with the tools given to them by the software. If they wish to change anything to better suit their goals, they will need to speak with the programmers behind it. Implementing any changes may also take up too much time, which may not be ideal for the highly competitive nature of drug and medical device development.
Cloud-based eClinical software is another option companies can consider as an alternative to paper data collection. In contrast with the expensive and inflexible nature of traditional installed EDC software, cloud-based software as a service (SaaS) allows companies to enjoy a subscription-based model with no need for additional IT resources beyond a computer connected to the Internet.
Because the information is not stored within the company's own resources, researchers may have concerns regarding how secure their data is on a cloud-based service. This all depends on the eClinical software provider. The best software offered as a service is built on a validated environment which is fully compliant with the regulatory standards essential to conducting clinical trials such as 21 CFR 11, Annex 11, EU Safe Harbor, Good Clinical Practice, and HIPAA.
As for accommodating changes to suit the particular needs of a study, a customizable interface eliminates their reliance on a software programmer. Also, because the cloud updates in real time, there is no need to wait for software updates. This improved flexibility also allows researchers to freely make mid-study changes.
Depending on the company or organization's goals and resources, their preferred option for an alternative to paper data collection may vary. But the cost benefits and flexibility of cloud-based clinical trial software SaaS make it a strong contender in the highly competitive arena of drug and medical device development. For more info, please visit Our Company