Importance of eSignature in Clinical Trials – Check Pros & Cons!

March 01, 2022
Importance of eSignature in Clinical Trials – Check Pros & Cons!

In recent years, the healthcare industry has gone through significant changes to improve work processes, increase compliance, privacy, and ensure utmost patient satisfaction. With the HITECH Act in place, the industry has witnessed a rising movement to build a national health infrastructure to enhance patient care, reduce costs, prevent errors and losses of records.

To ensure that the treatment is done more appropriately, it’s essential for the healthcare providers to rely on more accurate and authentic medical records fetched from the clinical trials management system to diagnose the cause of illness and disease more effectively.

To overcome this problem, the Healthcare industries have centrally focused on modernizing expensive and outdated paper-intensive business processes that are fully complied with standard regulations and laws too. On the other hand, implementing eSignature solutions to the clinical trial software could also be the perfect way to enhance the healthcare services. This not only helps healthcare providers to meet all compliance requirements but also helps them maintain self-privacy. 

Moreover, all the electronically signed documents in clinical management software come with a timestamp, an audit trail, and a tamper-proof seal that proves to be strong legal evidence in a court of law. 

How e-Signature Works in Any CTMS (Clinical Trial Management Software)?

Enabling e-Signature in Clinical Research Management ensures end-to-end electronic medical record processing in which the important documents of the patient get routed for automatic authentication and signature using eSignature solutions. 

The entire process is done within the computers or even the mobile devices. While handwritten notes have been painful for doctors and patients to maintain, the use of e-Sign enabled CTMS can be a stress-buster.

It helps healthcare providers to be on the move or see patients in their homes itself. Once they meet the patient, understand about their problems, and diagnose the causes of disease, their report documents will be automatically sent to their back-end system. Hence, it remains saved with patients as well as the doctors.

That’s where the system closes the loop and automates the entire process.

E-signature offers high-end security along with increased automation efficiency in the  registration areas, ER, and even at the bedside. Due to the tight integration between the eSignature solution and the EHR, this technology has a proven record to complement and enhance existing systems. It also helps maximize the ROI for the clinical platforms. There are many more benefits of having e-Signature in Clinical Trials. However, there are cons too. So, let’s dig deeper into both pros and cons of e-Signature in Clinical Trials.

Pros of E-Signature in Clinical Trials

  • Prevention from documentation errors. 
  • Lost documents are a headache no more.
  • Increased focus on patient care resulting in improved quality outcomes.
  • Increased visibility of forms.
  • Increased productivity in admission areas.
  • No scanning needed as e-Signed documents can be instantly archived.
  • Accelerated process.


  • Compromised security of the documents when the platform is not encrypted.
  • The e-signature needs verification which can’t be stipulated through any legal way.
  • The process of using an e-signature is difficult to understand.
  • Hardware and software may be obsolete.

If you’re also looking forward to implementing e-sign in your clinical trials, connect with us. We can help you understand the entire process and ensure seamless implementation with no hassles. Drop us an email or share your comments below.

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