Connected Clinical Trials Security Challenges and Solutioning

The primary purpose of a clinical trial is to identify drug efficacy and safety parameters in humans. The timely completion of a trial depends on numerous factors, including site performance, timely recruitment of patients, dropout rate, patient adherence and compliance to the treatment, and the ability to take related decisions faster. As patient-specific factors can lead to delays during trials, a strong digital connect presents an opportunity to build trust with patients.
Connected Clinical Trials is a unified stand that enables digitization of clinical trial processes, resulting in many fold enhancement to trial supply tracking, adherence to treatment schedule and overall patient engagement and retention during a clinical trial. In spite of many challenges, this platform aims to improve patient engagement, enhance medication adherence, expedite information processing and a big step to maintain tracking of medication processes.
The most of the healthcare ecosystem is sprouting speedily, resulting in amplified potentials from pharmaceutical entities. This is the innovative approach of providing clinical trial processes. Below figures indicate stakeholders, expectations, and opportunities for clinical trials.

Security Challenges:

Below are the security challenges, which needs to be responded inappropriate way during architecture and design:
  • Secure and Trusted Identities : allows clinical investigators to have one trusted digital identity to use
  • access governance, federation, and single sign-on software, help simplify user roles
  • Governance, Risk, and Compliance 
  • Lightweight dynamic encryption algorithm (field/pattern cipher/decipher) for mobile phones
  • Mobility access challenges
  • Data Privacy
  • Data impersonation
  • PHI data storage
  • App verification

Security Solutioning Roadmap

Security Deployment

Below diagram depicts the deployment scenarios for zeroing security compromises. 


It improves secure and trusted Identities, access governance, federation and single sign-on, governance risk & compliance (GRC), ciphering & de-ciphering, mobility access challenges.
Data in motion, data in use and data in transit should be protected by deploying appropriate encryption algorithms.


Digital clinical trials influence cutting-edge & prognostic analytics to generate evidential advantage of drugs, patient performance, and the genetic outcomes. It also indicates drug performance as well as its cost-effectiveness in a clinical situation. Auto report generation is based on analysis of metadata and outcome. This can be further leveraged to generate artificial intelligence logic. 
Authored By- Anil Kumar Dubey
TCS Enterprise Security and Risk Management


Rate this article: 
Average: 1 (22 votes)
Article category: