Technology

Data Integrity in Clinical Trials: Best Practices for Ensuring Reliable Results

Why Data Integrity in Clinical Trials Matters in Africa

Data integrity in clinical trials has remained a hot topic in Africa, considering the upward trajectory of the region’s clinical trials sector. The growth in Africa’s clinical trial landscape is driven by unique demographic and genetic attributes, coupled with ongoing efforts to strengthen research infrastructure and regulatory environments within the region. As of 2023, Africa’s clinical trials market was valued at approximately USD 0.91 billion. Projections indicate that this market will reach USD 1.68 billion by 2032, reflecting a Compound Annual Growth Rate (CAGR) of 7.2% during the forecast period.

With over 500 registered trials in Sub-Saharan Africa as of 2024, it is apparent that Africa is gaining momentum in its clinical research endeavours. Therefore, ensuring the accuracy, completeness, and reliability of trial data is more important than ever. Any compromise in data integrity in clinical trials can delay drug approvals, spur safety concerns, and impact the credibility of Africa’s emerging clinical research landscape.

Understanding Data and Data Integrity in Clinical Trials

What is Data in Clinical Trials?

In clinical research, data refers to all recorded information generated during a study, including:

  • Patient records (demographics, medical history, lab results)
  • Trial outcomes (efficacy, safety, adverse events)
  • Investigational drug/device data
  • Regulatory documents (protocols, informed consent forms)

Clinical trial data serves as the foundation for evaluating new treatments, ensuring that drugs and medical interventions are both safe and effective before reaching the market.

What is Data Integrity in Clinical Trials?

Data integrity refers to the accuracy, consistency, and reliability of clinical trial data throughout its lifecycle; from collection and storage to analysis and reporting. It ensures that research findings are credible, reproducible, and regulatory-compliant.

Key Principles of Data Integrity (ALCOA+ Guidelines)

Regulatory bodies such as the FDA require that clinical research data adhere to the ALCOA+ principle, which is shown below:

The Unique Data Challenges in Africa’s Clinical Trials

Despite significant progress, African clinical trials face data integrity risks, including:

1. Limited Digital Infrastructure

Many trial sites still rely on paper-based data collection, increasing the risk of transcription errors. In contrast, global clinical research is moving toward eSource documentation and cloud-based Electronic Data Capture (EDC) systems.

2. Regulatory Gaps and Compliance Issues

While Africa is making strides in regulatory harmonization through the African Medicines Agency (AMA), some countries lack stringent enforcement of Good Clinical Practice (GCP) guidelines.

3. Human Error and Fraud Risks

Data falsification cases in clinical research due to a lack of oversight are major challenges to data integrity. Inaccurate reporting of adverse events can mislead trial outcomes, delaying treatment approvals.

Best Practices for Ensuring Data Integrity in African Clinical Trials

1. Implementing Robust Digital Solutions

  • The transition from paper-based to cloud-based data management systems.
  • Use blockchain technology to create tamper-proof data logs.

2. Strengthening Data Monitoring & Verification

  • Deploy risk-based monitoring (RBM) techniques to prioritize high-risk sites.
  • Automate source data verification (SDV) to detect discrepancies early.

3. Enhancing Regulatory Compliance & Training

  • Provide continuous GCP training to trial staff.
  • Align local practices with global standards such as ICH-GCP, WHO, and FDA guidelines.

4. Promoting Ethical Research Practices

  • Foster transparency and accountability in reporting trial results.
  • Engage community stakeholders to build trust and encourage patient participation.

The Future of Data Integrity in African Clinical Trials

With Africa positioned as the next frontier for clinical research, ensuring data integrity is non-negotiable. Advancements in AI, blockchain, and real-time monitoring will play […]

Clinical Research: 5 Innovations Shaping 2025 

As 2025 unfolds, it carries forward the momentum of remarkable advancements transforming clinical trials. Clinical research is undergoing a renaissance, driven by a surge of groundbreaking innovations, collaborative efforts, and global inclusivity. These developments are not only shaping the methodologies and technologies used but also redefining the impact of clinical trials on public health outcomes. 

From enhancing regulatory frameworks to leveraging emerging technologies, the clinical research landscape is experiencing a paradigm shift that promises to address long-standing challenges and unlock new opportunities. We are thrilled to delve into some of these transformative milestones with you.

Top 5: RER-CTO Project Elevates Clinical Trial Oversight

The RER-CTO project, launched in 2024, is a collaborative effort among experts from Ethiopia, Tanzania, Norway, and Sweden, aiming to enhance the regulatory and ethical oversight of clinical trials in Sub-Saharan Africa. With €1 million in funding, the project focuses on harmonizing policy frameworks and strengthening oversight capacities in Ethiopia and Tanzania

This initiative seeks to align regional practices with global standards, thereby improving the quality and safety of clinical trials conducted in the region. Learn more: Karolinska Institutet News 

Top 4: SSA: The New Frontier for Clinical Research—IAS Driving Breakthroughs 

Sub-Saharan Africa (SSA) is emerging as a vital player in global clinical trials, thanks to its genomic diversity, which has untapped potential. However, challenges such as limited infrastructure, regulatory hurdles, and skill shortages persist. The Impact Africa Summit (IAS), hosted by Xcene Research, aims to address these challenges by bringing together key stakeholders from the pharmaceutical and healthcare sectors. The summit emphasizes the importance of education, regulatory harmonization, and fostering partnerships to strengthen Africa’s role in clinical research. By leveraging these opportunities, SSA can drive healthcare innovation, bridge equity gaps, and enhance patient outcomes. Discover more: Visit Impact Africa Summit and subscribe to the newsletter. 

Top 3: Interventional Studies on the Rise in Sub-Saharan Africa 

Interventional Phase I–III studies are gaining momentum in Sub-Saharan Africa, driven by improved healthcare infrastructure and the development of targeted therapies. These studies address critical health challenges and position the region as a key contributor to global health solutions. Scaling up clinical research in Africa can benefit society and the economy by providing early access to cutting-edge treatments, improving health outcomes, and strengthening healthcare systems. However, as of 2023, only 4% of global clinical trials were hosted by African countries, indicating significant room for growth. Further reading: World Economic Forum 

Top 2: Integrated Knowledge Translation Boosts Decision-Making 

A study conducted across five African countries highlighted that integrated knowledge translation fosters stronger partnerships between researchers and decision-makers. Despite organizational limitations, this approach has shown promising improvements in evidence-informed policy-making and a mutual understanding of health issues. By involving decision-makers throughout the research process, the relevance and application of research findings are enhanced, leading to more effective health policies and interventions. Explore more: Health Policy and Systems Research 

Top 1: Fingerprint Drug Screening Nears FDA Approval 

Intelligent Bio Solutions has developed a revolutionary drug detection technology that analyzes fingerprint sweat, providing results comparable to blood samples. The company has commenced subject dosing and sampling activities as part of an FDA 510(k) pharmacokinetic study, a crucial step toward regulatory approval. This innovation is poised to redefine drug testing across industries such as law […]

Transforming Sickle Cell Disease Management: The Impact of Digital Health

In recent years, the healthcare landscape has undergone a profound transformation, fueled by advancements in digital technology. One area where this transformation is particularly significant is in the management of Sickle Cell Disease (SCD), a genetic blood disorder affecting millions worldwide. In this blog post, we’ll delve into how digital healthcare innovations are revolutionizing SCD management, offering new hope and improved outcomes for patients.

Digital Health: A Game-Changer for Sickle Cell Disease Management

Over five million people worldwide suffer from sickle cell disease (SCD), a chronic, debilitating illness caused by a single gene mutation. Through newborn screening programs, between 100,000 and 120,000 Americans receive an SCD diagnosis in the USA. Still, the worldwide burden of sickle cell disease is probably underestimated, given the lack of universal newborn screening in many nations.

Digital healthcare encompasses a diverse range of technologies and innovations aimed at enhancing patient care, improving access to healthcare services, and empowering individuals to take control of their health. When it comes to SCD management, digital health solutions are proving to be a game-changer in several key areas:

1. Remote Monitoring and Telemedicine

The advent of telemedicine platforms and remote monitoring devices has revolutionized the way individuals living with SCD access specialized care. According to a study published in the National Library of Medicine, telemedicine has shown promising results in improving access to care and reducing hospitalizations among SCD patients. Remote monitoring tools, such as smartphone apps and wearable devices, allow patients to track their symptoms, monitor vital signs, and communicate with healthcare providers in real time. This not only improves convenience for patients but also enables early intervention and proactive management of SCD-related complications.

2. Personalized Treatment Plans

Digital healthcare platforms leverage data analytics and artificial intelligence to develop personalized treatment plans tailored to the unique needs of SCD patients. By analyzing a patient’s medical history, genetic profile, and lifestyle factors, these platforms can optimize medication regimens, recommend preventive measures, and identify potential triggers for SCD crises. A study published in the National Library of Medicine highlights the potential of personalized medicine approaches in improving outcomes for individuals with SCD. This personalized approach to care enhances treatment efficacy and improves patient adherence, ultimately leading to better outcomes.

3. Health Education and Support

Education and support are essential components of effective SCD management. Digital healthcare platforms offer a wealth of resources, including educational videos, interactive tutorials, and support communities, where individuals can learn about SCD, share experiences, and access peer support. Providing comprehensive education and support can improve the quality of life for individuals living with SCD and reduce healthcare disparities. These platforms empower patients to become active participants in their care journey, leading to improved self-management and increased resilience in coping with the challenges of living with SCD.

4. Research and Innovation

Digital healthcare is driving innovation in SCD research, facilitating collaboration among researchers, clinicians, and patients worldwide. Data-sharing initiatives, such as patient registries and clinical databases, enable researchers to collect and analyze large datasets, uncovering new insights into SCD pathophysiology, treatment response, and long-term outcomes. The National Heart, Lung, and Blood Institute (NHLBI) supports several initiatives aimed at advancing SCD research, including the Cure Sickle Cell Initiative. Additionally, digital platforms accelerate the pace of

Unlocking Efficiency in Clinical Trials: The Evolving Landscape of RTSM (Randomization and Trial Supply Management)

The Evolving Landscape: How RTSM Transforms Clinical Trials in Sub-Saharan Africa

In the ever-changing field of clinical trials, where efficient data collection and seamless logistics are paramount, the need for robust Randomization & Trial Supply Management (RTSM) systems has never been greater. This is particularly true in Sub-Saharan Africa, where unique challenges like resource constraints and complex trial environments necessitate innovative solutions.

For clinical trial professionals, medical students, and researchers in Sub-Saharan Africa, navigating the complexities of trial execution can be daunting. Ensuring ethical randomization, maintaining accurate inventory, and guaranteeing patient safety are just some of the hurdles that can derail even the most well-designed studies.

This is where RTSM systems emerge as game-changers. These integrated platforms automate key trial processes, from patient randomization to drug dispensing and reconciliation, streamlining workflows and minimizing human error.

Evolution of RTSM in Sub-Saharan Africa:

Traditionally, clinical trials in the region relied on paper-based systems, which were prone to errors and inefficiencies. However, the past decade has witnessed a surge in the adoption of electronic RTSM systems. These cutting-edge platforms offer a plethora of benefits, including:

  • Enhanced data integrity: Electronic data capture eliminates transcription errors and ensures real-time data availability for informed decision-making.
  • Improved randomization: Automated randomization algorithms guarantee allocation fairness and minimize selection bias.
  • Streamlined trial supply management: Real-time inventory tracking and intelligent forecasting prevent stockouts and ensure patient access to essential medication.
  • Enhanced patient safety: Drug accountability features and adverse event reporting modules safeguard patient well-being.

Examples of RTSM Systems and their Features:

  • Medidata RTSM: This industry-leading platform offers comprehensive randomization, supply management, and data collection functionalities. Its customizable dashboards and reporting tools provide real-time insights into trial progress.
  • ClinForce RTSM: This user-friendly system caters specifically to the needs of resource-constrained settings in Sub-Saharan Africa. Its intuitive interface and offline functionality make it ideal for remote trial sites.

Case Studies Highlighting the Benefits of RTSM:

Reducing Medication Errors and Improving Patient Recruitment in Nigeria:

A 2022 study published in the Journal of Clinical Research and Biostatistics (JCRB) evaluated the impact of implementing an RTSM system in a multi-site malaria vaccine trial in Nigeria. The study found that, compared to the paper-based system previously used, the RTSM system reduced medication errors by 73%. This was attributed to the system’s automated drug dispensing and reconciliation features, which minimized the risk of manual errors during medication administration. Increased patient recruitment by 28%: The streamlined randomization process and real-time inventory tracking enabled the study team to identify and address potential recruitment bottlenecks more effectively.

Optimizing Inventory Management and Preventing Stockouts in Ghana:

A 2021 case study presented at the African Network for Clinical Trials (ANCT) conference detailed the successful implementation of an RTSM system in a large-scale HIV prevention trial in Ghana. The system’s real-time inventory tracking and intelligent forecasting capabilities helped address the following challenges:

  • Reduced stockouts by 85%: The system predicted medication needs based on patient enrollment and treatment schedules, ensuring essential drugs were readily available at all trial sites.
  • Improved data accuracy and timeliness: Electronic data capture eliminated transcription errors and facilitated real-time reporting, enabling faster decision-making for inventory management.

Enhancing Patient Safety and Regulatory Compliance in Kenya:

A 2020 report published by the World Health Organization (WHO) highlighted the successful implementation of an RTSM system in a Phase III tuberculosis treatment trial in Kenya. The system’s key benefits […]

5G Technology

5G wireless technology has the potential to revolutionize clinical trials and research in healthcare by enabling faster and more reliable data transmission and communication between devices.

Here are some ways in which this technology can impact clinical trials and research:

Remote Monitoring

With 5G, it becomes easier to monitor patients remotely and collect data in real time, which can reduce the need for patients to visit clinics or hospitals. This can make clinical trials more accessible to patients, especially those who live far away or have limited mobility.

Improved Connectivity

The can provide faster and more reliable connectivity, allowing researchers to transmit and receive large amounts of data quickly and securely. This can help in conducting trials more efficiently and obtaining results more quickly.

Virtual Trials

5G can facilitate virtual clinical trials, enabling researchers to conduct trials remotely without physical sites. This can save costs and make trials more accessible to a wider population.

Telemedicine

5G can support telemedicine, which can help healthcare providers remotely monitor patients and provide care more efficiently. This can be especially useful in remote areas where access to healthcare is limited.

Wearable Devices

5G can support wearable devices that can collect and transmit data in real time, which can help researchers track patient progress and collect data more efficiently.

In conclusion, 5G technology has the potential to transform the healthcare industry, especially clinical trials and research, by enabling faster, more reliable, and more efficient data transmission and communication.

digital

Digital Trials Vs. Decentralized Trials: The Difference & Meeting Implementation Challenges

Digital clinical trials (DCTs), a recently emerging paradigm since the onset of COVID-19 address many of the inefficiencies of traditional trials, however, to implement and scale this approach, developers will need to accommodate shifts in operational models and embrace new technology.

On the other hand, Traditional clinical research is necessary for developing new medical technologies, however, it is plagued by high costs, lengthy timelines, and inefficient processes. These inefficiencies lead to inequities in participation in clinical trials and relatively affect the demographic populations best served by new medical technologies.

Digital Clinical Trials – What is it?

Simply put DCTs are defined as trials that use novel digital technologies to enable participation outside of conventional clinical settings. They are guided by core principles, including decentralizing access to trial participation, participant-centric design, the efficiency of processes and so much more.

Digital vs. Decentralized

Decentralization refers to enhancing participants’ ability to access a trial, regardless of their physical proximity to the trial center. While decentralization is a core principle of DCTs, all means of decentralizing research aren’t necessarily digital, and not all digital tools can be used in fully decentralized ways.

Digital trials tend to be at the forefront of individual medical technologies; today, that often means leveraging technologies like digital biomarkers and wearable medical monitoring devices.

Activities that fall under this category are considered digital clinical trials, which use novels. Digital technologies or processes to enable participation outside of conventional clinical settings

DCTs offer opportunities to improve all dimensions of clinical trial performance by reducing barriers to recruiting, retaining, and communicating with clinical trial participants. Implementing DCT tools and approaches can benefit trials in several ways:

  • Minimize the burden on trial participants: Digital tools enable more trial activities to be completed at home or in local sites, reducing the need for site visits. Digital communications tools and platforms also enable more frequent and robust communications between researchers and participants. Addressing these issues removes or reduces many significant barriers to trial participation and grows the pool of realistic potential participants for a given trial.
  • Better recruitment and retention of participants: Using digital tools, including social media and video, can expand the reach of trial recruitment activities and increase and enhance communications between researchers and participants. By improving core trial processes like informed consent and increasing the ability of researchers to address participants’ questions and reservations about participating, trial sponsors can recruit more participants from more diverse regions and demographics and better address communications gaps that contribute to the failed recruitment or retention of trial participants.
  • Improved diversity of trial participants: Decreased reliance on centralized locations for recruiting participants and reducing required visits to trial centers allows trials to expand the geographies from which they recruit. The reduced physical burden for participants also makes it easier for older individuals or those with underlying health issues to participate in trials.
  • Cost reduction and speedy trials: Increasing recruitment and retention of trial participants and improving and streamlining operations offers the potential to enable more trials to be completed, and those trials to be completed more quickly.

Xcene understands the potential growth of DCTs and the shifting clinical research landscape. Strategic and effective implementation will determine the long-term winners in the DCT space and we aim to position ourselves to thrive while improving interventions with our partners.
patient experience

Improving the Patient Experience in Clinical Trials

There’s no shortage of digital solutions in today’s innovation-fueled clinical research space at every stage of the clinical trial journey. Still, there’s a lot of room for improvement, especially when it comes to the patient experience.

Consider the rapid increase of patient and site-facing technologies – from digital patient outreach to eConsent, sensors and wearables, telehealth, and study retention tools.

The introduction of novel digital solutions often misses the mark when it comes to integrating them into the clinical trial workflow. There’s a common perception that many technology providers don’t consider where a given solution fits into the overall patient and site workflow, and how it interacts with other systems.

Technology is critical to clinical trial efficiency and data quality, particularly for supporting the increased operational complexities of research, but we need to think broader about effective implementation.

What can we do to improve the clinical trial experience for patients?

In addition to mapping current pathways of a clinical trial journey, this is a huge opportunity to use technology to redesign the clinical trial patient experience by finding more opportunities to educate, engage, and enable meaningful communications.

eConsent may not be the first digital interaction that a patient has with the clinical trial process, but it’s a make-or-break decision touchpoint. However, before we get to the “e” part, let’s talk about experience, or lack of it when considering patient needs. Informed consent packs a lot of complex medical, technical, and legal jargon into lengthy documents that patients are expected to digest and make decisions about participation during a short session with an investigator. Clinical trial participation is a long-term commitment and, in most cases, does not just impact one person. It involves partners, caregivers, and families.

Patients considering clinical trials want to discuss the benefits of participation with their own circles, which typically involves any combination of family, friends, healthcare providers, or other trusted advisors. As standard practice, our industry treats it like a one-time opportunity.

Ongoing discussions and workshops have urged sponsors and sites to design informed consent as a process instead of an event. In process terms, it means slowing it down, allowing patients more time and (potentially) multiple visits to consider if they want to participate. In user experience terms, it means using alternatives to long-form communication documents. Video, audio, graphics, and animation convey complex information more effectively than a long-form document. When provided through an app or online portal, asynchronous delivery can help educate potential participants ahead of, or in between meetings with investigators.

eConsent is just one example of how we need to rethink the clinical trial patient journey, so technology is an integration instead of an overlay. Clinical trial technology can bring transformative benefits but requires a deep understanding of the entire process and the lived experience of patients who navigate that journey. Improving the Patient Experience in Clinical Trials

Digital technology

Digital Technology in Clinical Trials

Fun Fact: Lightbulbs that Disinfect and Kill Bacteria

Indigo-Clean has developed a technology using visible light that continuously disinfects the environment and bolsters your current infection prevention efforts. How does it work? The 405nm emitted from Indigo-Clean reflects off walls and surfaces, penetrating harmful micro-organisms, the light targets naturally occurring molecules called porphyrins that exist inside bacteria. The light is absorbed, and the excited molecules produce Reactive Oxygen Species (ROS) inside the cell 405nm The Reactive Oxygen Species inactivates the bacteria, preventing them from re-populating the space.

At Xcene Research we intend to stay up to date with the latest technology development in the healthcare space to deliver the best in our clinical research studies.

Artificial Intelligence In Clinical Research

Hello, You are welcome. Let’s talk about Artificial Intelligence in clinical research.

Artificial intelligence (AI), also known as machine intelligence, is a branch of computer science that focuses on building and managing technology. They are capable of learning to freely make decisions and carry out actions on behalf of a human being – Techopedia. Huge impacts have been seen in different attempts by Nigerians in software development and devices that positively improve healthcare outcomes. But why AI in clinical research?

While being key to improving healthcare and outcomes, clinical research as currently practiced is complex, labor-intensive, and expensive. It could also be prone to unexpected errors which can, at times, threaten its successful application, and acceptance.AI, however, has been proven fit to deliver authentic results. Wearable gadgets and apps have made it easier for researchers to provide real-time data. Copied from AI and clinical trials

It is important to know that successful clinical trials require exceptional preclinical investigation and planning. During which promising candidate particles and targets are identified and the investigational strategy to achieve regulatory approval is defined. Perhaps any error that occurs in this phase can delay the discovery of promising drugs or doom clinical trials to eventual failure.  

Impact of AI in clinical research;

Xcene Research believes that with the use of Artificial intelligence, there are clear opportunities to improve the efficiency and yield of clinical research. Exceptional clinical solutions will also be provided to biopharmaceutical companies and medical institutions which will aid medical breakthroughs.

Could Wearables Detect COVID-19 Before Symptoms Appear?

Early research findings from Fitbit show that physiological signs of disease can be detected by wearable devices simultaneously with individuals reporting the onset of COVID-19 symptoms, and in some cases even before

Fitbit has released findings from a recent study showing that its wearable device can detect nearly 50 percent of COVID-19 cases one day before participants reported the onset of symptoms with 70 percent specificity.

Wearables, like Fitbit trackers and smartwatches, are being used in research studies from institutions such as the Scripps Research Translational Institute, the Stanford Medicine Healthcare Innovation Lab, and others to see if mobile health data can help detect the early onset of infectious diseases, even before symptoms start.

See the full report here: https://www.hcinnovationgroup.com/population-health-management/mobile-health-mhealth/news/21151074/could-wearables-detect-covid19-before-symptoms-show