Clinical Trial Monitoring

Clinical Trial Monitoring

The global epidemic presented difficulties that the healthcare sector had not anticipated. However, it also provided a platform for trial-related innovation. Clinical research has never before used virtual technology or digitalized processes, particularly in monitoring, thanks to the pandemic’s impetus for using new technology in a field that is frequently cautious and slow to adapt.

Acceptance and quick integration of remote and centralized monitoring and advanced analytics in place of more conventional on-site procedures is one such trend.

Running an effective and compliant clinical trial requires careful monitoring. The site monitoring approach is currently laborious, expensive, and vulnerable to problems with data quality. A clinical trial’s monitoring costs are typically 25% to 30% of the total cost. More crucially, improved clinical outcomes are made possible by effective monitoring. Transforming clinical trial monitoring will quicken the trial process while increasing effectiveness and cutting expenses.

Monitoring makes sure that

  1. We follow the trial protocols.
  2. Data relevant to various components of the study, such as adverse events and dosage information, is collected.
  3. The human rights of patients participating in clinical trials are respected.
  4. The clinical trial site’s data collection and submission are accurate.

A site monitor, the Clinical Research Associate (CRA), conducts several checks ups that are currently done manually and on-site to guarantee the human rights of the patients engaged. 

As an example

  1. By looking to see if patients have signed, the site monitor confirms that all Informed Consent Forms (ICFs) have been read and understood by patients.
  2. The monitor also guarantees that all subjects (patients) are qualified for the experiment by verifying the eligibility requirements.
  3. The monitor confirms that website reports any undesirable occurrences validating the source systems and the reports.

Transforming site monitoring does the same thing in an easier and different way.

Modernizing monitoring 

We can notice the technology’s ability to enable change in trial monitoring in several ways, such as;

  1. Automated key risk indicator (KRI) management
  2. Early signal detection in patient safety and eligibility
  3. Workflows that can be thoroughly audited and tracked to manage risks at the study, site, and patient levels.

When considering monitoring modernization in small steps, sponsors may define integration as:

Level 1

Delivering RBM using risk-based tactics and centralized monitoring can reduce the requirement for clinical research associates (CRAs) to conduct on-site monitoring visits.

Level 2

Remote patient and site management is made possible by linking RBM and decentralized trials (DCT) with integrated monitoring capabilities and a developing DCT technology framework. 

Cutting back on onsite-specific activities frees up time and focus on patient needs.

Level 3

Use patient-generated data from remote monitoring data gathering to improve direct-to-patient tools and procedures and further alter clinical monitoring.

Integrated technologies

Sponsors should confirm that necessary information is accessible and available to transition to remotely-managed sites. Trial design and process, including streamlined protocols and fit-for-purpose Electronic Data Capture (EDC) design, are crucial elements to guarantee that data integration enhances downstream processes without adding to the constraints placed on patients and sites.

Learn about different types of clinical trial monitoring

Data collection (EDC, eTMF, EHR)

  1. You can read text from scanned manuscripts and patiently save it in the available specialized software. 
  2. Choose to have files for various patient files from several places. 
  3. Use eConsent to validate signatures with a legitimate identity for informed consent.
  4. It is possible to store data from an electronic health record (EHR).
  5. You can use EDC and eTMF to collect and store data.

Transcription of data

You can use software to translate speech to text for doctor-patient talks and store the data.

Data analytics (EDC, eTMF, EHR)

Using software to combine clinical trial data has benefits over the experiment and clinical trial monitoring. In addition to storing the structured and semi-structured data, the program also allows for the analysis and creation of structured data sets. 


The monitor must indicate that the investigator’s office has received the information brochure. It is possible to accomplish this by centrally storing the brochure, emailing a link, and requesting read confirmations from trail participants at the investigator’s office. Any one can track deviations and report.

Understanding the benefits

Despite the shifting clinical development landscape, emphasizing patient safety and improving patient outcomes—where data quality plays a critical role—remains the one constant for all industry stakeholders. 

Understanding the “why” of modifying a sponsor’s approach to monitoring is necessary as they evaluate contemporary ways of observation. RBM and centralized monitoring provide several advantages, such as:

Making all patients achievable in the future

By more effectively integrating systems and using previously available capabilities, we can make all patients achievable in the future. We must take into account the patients who have limited access to health information, who are underinsured, who lack access to health care professionals, or whose doctors are unfamiliar with or do not have access to clinical trials or innovative treatments. 

All patients must have access and understanding, information, choices, and care, whether or not they have smartphones or internet connections. By collaborating with dependable communication hubs, health care research access and providing cutting-edge cures must penetrate more deeply into local communities. 

Advancing patient input

Finding the best diagnoses, therapies, or clinical trials might be difficult for patients today. Understanding and overcoming these difficulties have been made much easier with the help of patient participation. 

A more effective way to translate research into practice would be to better coordinate objectives for patient involvement in medical product research and development with regulatory decision-making about early disease identification, disease management, and treatment. Moreover, transforming formerly anecdotal patient feedback into rigorous, reliable evidence for use by stakeholders could enhance patients’ experiences and results in clinical research and care.

A path forward

  1. Give participants a chance to involve in clinical research, stay in touch, and get long-term follow-ups.
  2. Create and encourage more opportunities for the network of researchers and healthcare providers to participate in clinical research.
  3. Create An Open Discussion For Patients And Healthcare Professionals To Address Queries And Concerns Regarding The Disparities Between Research And Clinical Care

Automated detection and real-time monitoring of

  1. Keep an eye on insights to make timely adjustments.
  2. Possibility for reducing the frequency of probable errors 

Early signal identification and assessment of data at the subject level

  1. aids in achieving high data integrity and quality, preventing end-of-study delays.

Using automation to speed up operations can

  1. Facilitate the reporting of study outcomes.
  2. Slash overall timeframes to bring medicines to market sooner.

Regulatory background (FDA, HIPPA and GCP)

As part of compliance, protecting and encrypting patient data is crucial. The design users must ensure full traceability, monitoring, and encryption of personally identifiable information.  

  1. The FDA 21 Code of Federal Regulations (CFR) Part 11 mentions the rules for clinical studies utilizing electronic records and signatures. You must be aware of your electronic record system’s characteristics and the steps you must take to use it to comply with Part 11.
  2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) forbade the disclosure of private patient health information without the agreement or knowledge of the patient. The two core elements of HIPAA are privacy regulation and the security rule.
  3. GDPR safeguards the people’s rights to reasonable control and better information. To do this, the GDPR increases the legal justification for handling personal data and gives data controllers and processors new responsibilities.


Helping pharmaceutical companies and Contract Research Organizations (CROs) transition to a centralized risk-based hybrid (remote or hybrid) monitoring approach was necessay during COVID-19 situation. 

This method helps technology to automate many of the laborious and manual tasks carried out by site monitors, allowing them to concentrate their attention on the caliber of the trials while being more effective and efficient. 

Additionally, this automation reduces errors, enhances data quality, and ultimately increases patient safety in clinical trials.

Do You Have Any Questions For Digital Monitoring?

Digital tools are becoming necessary to manage and monitor clinical trials effectively and efficiently. Clinvigilant offers its expert services in transforming your clinical trials to digital. Provide your details below to connect with us.

Provide your questions or brief info about what kind of support you are looking for
Provide your work email