Addressing the Challenges of Global Clinical Trials

The number of global clinical trials increases every year - with them comes new challenges. Driven by increasing demand for innovative medical therapies, pharmaceutical companies are spending more on new research, yet are still struggling with certain operational workflows. 

The disconnect between increased investments and a lack of new effective therapies stems from the challenges that biopharmaceutical companies and contract research organizations face with global clinical trial management.

Successful drug development relies on overcoming these challenges. Here, we will examine the leading issues global clinical studies face. We will also explain how our products can address them to help companies conduct their studies efficiently and successfully.

Leading Challenges of Global Clinical Trials

Clinical study teams face many challenges. Here are the most pressing ones inhibiting the successful development of new medications.

Patient Recruitment

Recruiting patients, keeping track of them, and retaining them in studies are among the main challenges with worldwide trials. 

Clinical trial managers must devise effective strategies to recruit eligible candidates with the correct criteria for effective drug development. These strategies must comply with local regulatory requirements while making it easy for study teams to track patient responses. Guidance on best practices to retain patients also must be more widespread.

Visibility

When trials span multiple sites around the globe, visibility is often limited. Data standards, healthcare infrastructure, and electronic health record systems can vary between regions. Additionally, the spread of various clinical systems makes it difficult for sponsors to stay informed about the progress of the study across multiple metrics at a regional, trial, and site level.

Training Team Members

Another challenge facing global clinical trial management is training team members. Due to the large scale of global clinical trials, tracking which team members must complete specific training at a particular stage can be difficult.

A lack of consistency in training across different sites can result in some members completing training multiple times while others don’t receive study-specific training. Inefficient training can lead to critical study issues, including data quality and patient safety. 

Additionally, if time-consuming paper delegation logs are used, there is a higher risk of data entry errors and duplication. Since paper logs require physical distribution, they also limit accessibility for reviewing or updating the delegation log. Ensuring that all relevant members have the most current version and keeping the delegation log audit-ready can be challenging, increasing the potential for mistakes due to referencing outdated information.

Furthermore, paper delegation logs are more susceptible to loss, damage, and unauthorized access. Paper-based delegation systems may not integrate seamlessly with other trial workflows and management systems, resulting in siloed data, as well as hindering the overall efficiency of the clinical trial workflow.

Data Management

The various countries conducting clinical trials all have different data management standards. Clinical trial administrators are responsible for collecting, managing, and reporting this data most efficiently.
While conducting global clinical trials, they face challenges such as quality, accuracy, and safety of the collected information. Without a secure and reliable platform, this data can get lost, undocumented, or altered, compromising the integrity of the entire study.

Monitoring

Another challenge with global clinical trial management is monitoring all studies from a remote base location.  Sponsors may find it hard to visit each of their sites routinely. However, monitoring these sites is necessary to ensure patient safety, maintain data integrity, and provide accurate results. 

Effective monitoring requires close collaboration between sites and sponsors to identify critical issues and develop practical solutions. However, individual site visits are costly and consume valuable time at each site, impacting the overall duration and expense of the trial.

Regulatory Compliance

Another critical challenge for global clinical trials is navigating the regulatory requirements of different countries. Each country has a set of regulatory guidelines that sites and sponsors must adhere to during clinical trial administration. 

Apart from national regulations, such as 21 CFR Part 11 Electronic Records; Electronic Signatures, clinical studies must also comply with international guidelines, including ICH-GCP. Ensuring proper compliance can lead to a time-consuming and complex process of approvals for clinical trials.

How We Address the Challenges of Global Clinical Trials

With over 25 years of expertise in the biomedical field, we understand the challenges of large-scale clinical trials and provide digital services that effectively address them.

Effective Patient Recruitment and Tracking

Using our multi-sponsor collaborative software, SiteCloud, sponsors can recruit patients and schedule tracking to learn how well they engage with the study.

Automated Task-Based Training

Through the eDelegation of Responsibilities module, our software provides investigators with a digital dashboard that facilitates seamless delegation of authority and training to site staff, based on either tasks or roles. Investigators can automatically assign training to team members of global clinical trials, track training completion status, training certificates, and delegation acceptance.

Additionally, our eLearning Management System provides the ability to deliver, track, and upload certificates for site-user training – as well as automatically distribute training to new sites, transferring applicable training credits across trials to reduce repetition of training for site staff.

AI-Enhanced Document Exchange

Our AI-enhanced solution streamlines document exchange for clinical trials, with the automatic distribution of study documents to new sites, receipt of document submissions from site staff with front-end QC, and an automated integration to send them directly to your eTMF. At the study’s end, you can easily export the complete trial document package – including audit trails and critical reports for sites.

A real-time electronic Investigator Site File (eISF) is accessible by sites at any time, and with a single click, site staff can upload composite site documents without any further burden. Our highly accurate artificial intelligence engine will automatically categorize, detect language, extract relevant metadata, and QC the documents. This enables CRAs to sort and check these documents at a substantially quicker pace.

Remote Monitoring

Our collaborative global clinical trial management platform allows them to track hundreds of clinical trials worldwide remotely – supplementing on-site visits and helping to make them more productive.

With remote monitoring, sponsors can reduce their travel time and arrive at study sites equipped with knowledge about each site’s activities, improving efficiency and effectiveness of onsite visits.

Streamlined Compliance

Compliance is no longer an issue as our sponsor-controlled investigator platform, StudyCloud, provides sponsors with clear status tracking of items and complete audit trails – allowing them  to simplify paperwork and meet local and international regulatory standards with built-in rules.

Overcome the Challenges of Global Clinical Trials With InnovoCommerce

Effective management of global clinical trials is essential for acquiring reliable data that leads to medicinal discoveries. This effective management – and the success of clinical trials – encompasses reliable patient recruitment, maintaining visibility, efficient staff training and delegation, comprehensive data management, productive site monitoring, and regulatory compliance.

InnovoCommerce can help you navigate these challenges. With our software solutions, you can develop a global approach that improves patient recruitment, enhances visibility, automates staff training, streamlines data management and document exchange, provides remote site monitoring, and ensures regulatory compliance to harmonize study conduct quality, and optimize trial timelines.