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Computer System Validation in Clinical Trials

surgeon looking at mri scan on computer

Clinical trials evaluate the safety and efficacy of an investigational product is used to treat, cure and manage diseases that affect human race and assess health outcomes. ICH GCP (International Conference of Harmonization Good Clinical Practice), defines clinical trials as “Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.”

There is an ever-increasing need for newer, better and safer drugs to combat the ever-evolving disease landscape, such as in case of antibiotics, emergence of new bacteria and viruses and evolution of old ones has demanded better antibiotic treatment as the effects of old ones diminish. There is a constant pressure on the industry from business, governments, civilian groups, and patient advocacy groups to cut down the cost of newer medicines, and make it available in a short period of time. Drug development is marred with delays and redundant processes. The pharmaceutical industry is finding innovative ways using advanced technology to improve their business processes and operations to curb costs, reduce time-to-market and meet demands.

Recently, pharma and contract research organizations are focusing their attention to emerging technologies to improve their processes, thereby pushing regulators to evolve and upgrade existing regulations, and showing a broader outlook towards use of technologies in clinical trials and drug development. It is crucial for organizations to implement advanced technologies to keep pace with the ever-changing disease landscape and participation of patients and other stakeholder in clinical trials.

The business and operational processes of clinical trials have been slow to catch up with emerging technology and it’s imperative for pharma and contract research organizations to adapt these changing technologies for business transformation in this today’s digital age. Embracing technologies often brings its own set of complexities, often exacerbated by strict regulations in clinical trials and drug development, and new tools and technology need to meet all regulatory mandates before using for clinical trials.

A process critical step in using technology platforms in clinical trials is the computer system validation of these tools to ascertain the functionalities and applications of the systems are on par with the mandate and requirement standards. There are three important areas that these technologies need validation for – regulation, technology and security.

figure showing key figures in validation of clinical trials

Fig. Key Elements in Computer System Validation of Clinical Trials

Technology and Regulation

It is important that these computer systems comply to the most recent regulatory standards when it comes to implementing them in clinical trials. Both USFDA (United Stated Food and Drug Administration) and EMA (European Medicines Agency) have very robust requirements for systems operations and privacy of patient data. It is important for the vendors of these systems to be aware and understand the most current regulatory requirements when it comes to computer systems validation. Stringent adherence to 21 CFR (Code of Federal Regulation) part 11, cGMP (Current Good Manufacturing Practice), GLP (Good Laboratory Practice), GAMP (Good Automated Manufacturing Practice), HIPAA, and GDPR are mandatory. All vendor teams involved need to be trained on domain as well as regulations for awareness and compliance before validating computer systems. The advanced technologies used in clinical trials space and drug testing industry have had a positive impact on various operational hurdles such as patient recruitment, site selection, investigator selection, trial forecasting and optimization, etc. It is very important to assess that right systems be used for the right purpose and systems should be “Fit for Purpose”. Computer systems validation allows pharma and the contract research organizations understand the applicability and functionality of the systems for an intended purpose, wherein changes can be incorporated as per requirement.

Data Security

The platforms used in clinical trials settings contain critical patient information. These systems keep exchanging patient data continuously over the internet and need to be protected. GAMP (Good Automated Manufacturing Practice) principles outline the requirements for patient safety, records and data integrity while employing computer systems validation which plays a key role in the overall integrity of data and the systems. It is critical to validate the consistency of these systems and understand the security of patient data. It is important to secure patient data via encryption at different point of times. Validation teams involved in sprints, testing, validation, deployment should have an in-depth understanding of these eSystems and its application in clinical trials to recognize the overall criticality of the process.

Although pharma/CROs are responsible for the validation activities and ensure that validation vendors serve their clients suitably, vendors are also liable to audits and inspections from Pharma/CROs and regulatory authorities respectively. It’s important for vendors and their teams to have a thorough understanding of computer systems validation under GxP (Good Practice) and should have a robust internal management system for a seamless validation workflow. The vendor follow proper documentation practices, trainings, and quality management system, CitiusTech has robust capabilities in this regard with relevant ISO certifications and a well-established QMS workflows when it comes to handling sensitive patient data.

A vendor that provides services to pharma/CRO in terms of validation should have an internal SOP management system for various procedures in developing, testing, validating, and deploying computer systems to be used in clinical trials. A final specification document and in-depth understanding of business requirements is also necessary. All tests should have fully executed test scripts, a follow-up test scripts (if the test fails), documents highlighting retesting, documentation on removal of functionalities. Complete user testing specification should be documented, and any remedial actions should have appropriate approvals and signoffs. The system and regulator should be kept in mind before conducting any computer validation. There should be a completely evident documented chain of events available for a vendor audit or inspection by regulatory authorities concerning specific validation process such as change management for systems, traceability to the requirements, version control for the entities managed by other systems. There should not be any missing information which may create ambiguity, for instance a part of the system is live without testing and validation, which could compromise the integrity and security of data.

Computer system validation is a mission critical process in harnessing the power of technology in clinical trials and drug development, and should be conducted in a robust manner by appropriate stakeholders and host the right team for such critical and sensitive activity.


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