Case Studies
Case 1 - Study Recruitment Acceleration
Issue
A pharmaceutical company conducting a study on Non-Alcoholic Steatohepatitis (NASH) encountered challenges with slow participant recruitment. This delay posed a significant risk to meeting the expected timelines for data delivery.
Action
To address the recruitment issues, it was decided to expand the study to additional countries. The following steps were taken:
- Several clinical sites worldwide were contacted and provided with a feasibility questionnaire.
- A thorough analysis of the sites' capabilities and suitability was performed.
- Site visits were conducted to further assess and qualify the selected locations (in China and Jordan).
Outcome
As a result of these actions, contracts were finalised and approvals from Ethics Committees (EC) and Regulatory Authorities (RA) were obtained. Ultimately, recruitment was completed successfully, allowing the study to progress as planned.
Case 2 - Early Clinical Programme Initiation for a Biotech Company
Issue
A Swiss biotech company is embarking on its first early clinical programme without prior experience in this field. This lack of background presents challenges in navigating the complexities of clinical research, particularly in identifying suitable partners and ensuring the programme progresses efficiently.
Action
To address these challenges, Explora focused on selecting an appropriate phase 1 clinical site capable of managing the entire phase 1 programme. This included conducting Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Drug-Drug Interaction (DDI), and Food Effect (FE) studies. The chosen site was responsible for executing the studies and ensuring the timely delivery of high-quality data.
Outcome
As a result of these efforts, the phase 1 data package was successfully delivered within a two-year timeframe. This achievement enabled the product to advance into phase 2 clinical development.
Action
Explora addressed these challenges by selecting study sites in Mali, Ghana and Gambia. In order to ensure the integrity and reliability of the trial, all sites were required to adhere to the same study protocol and follow identical study procedures. Furthermore, capacity building efforts were implemented to support the sites and enhance their ability to conduct the study effectively.
Outcome
The successful execution of the phase 3 clinical study resulted in a robust clinical package. This achievement enabled WHO prequalification of a meningitis vaccine, which is now widely used across sub-Saharan African countries.
Issue
During the conduct of a phase 1 clinical study at a UK site, a significant technical issue arose when administering a liquid drug product. The problem prevented the full dose from being injected into participants, which in turn halted the progress of the trial.
Action
Explora responded by visiting the site and collaborating directly with site personnel to review their injection techniques. Multiple options were tested to ensure the full dose could be administered. Once the issue was successfully resolved, the injection procedure was rewritten to incorporate the improved technique.
Outcome
Following these interventions, the study was able to progress without further complications, resulting in the collection of a comprehensive and reliable phase 1 dataset.
Issue
During a clinical study conducted in the United States, the Sponsor encountered challenges in recruiting participants after the study had been on hold for several weeks.
Action
Explora addressed the issue by travelling to the United States and engaging directly with the site teams. This involved reviewing their recruitment practices, examining recruitment logs, identifying key obstacles hindering enrolment, and working to re-motivate site personnel.
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Outcome
As a result of these efforts, the study protocol was amended to better facilitate participant recruitment. The encouragement and renewed focus provided to the site teams led to a successful resumption of recruitment activities, ultimately allowing the study to be completed within an acceptable timeframe.
Issue
A Not for Profit organisation was seeking to identify a suitable site to undertake a high-risk clinical study in Australia, specifically a volunteers infection study. The unique nature of this study required a site with the capability and expertise to safely conduct unconventional clinical research.
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Action
In collaboration with the Sponsor’s Medical team, Explora took responsibility for the process by selecting, visiting, and qualifying a new phase 1 site in Australia. The site was thoroughly assessed to ensure it satisfied all safety and operational criteria necessary for conducting a study of this complexity.
Outcome
Following qualification, the chosen site successfully completed several phase 1b studies involving various drug candidates. All studies were conducted without any incidents, and were delivered within the allocated budget and timelines, consistently meeting high quality standards.
Case 7 - Cleaning and Preparing an e-TMF for Audit and Inspection​
Issue
An electronic Trial Master File (e-TMF) compiling documents from several studies was found to require extensive cleaning before it could be considered suitable for an audit or inspection. The presence of gaps and inconsistencies in documentation meant that the e-TMF was not ready to meet regulatory standards.​
Action
Working closely with the Sponsor’s Quality department, Explora undertook a thorough review of the e-TMF. The team identified all gaps and inconsistencies, then proactively contacted the participating sites to collect any missing documents. Pending queries were diligently resolved, and File Notes were produced where necessary to ensure completeness and clarity of the documentation.​
Outcome
As a result of these actions, the e-TMF was fully prepared for archiving and achieved a status of being 100% inspection ready.
Issue
The Sponsor is responsible for keeping the clinical trial records registry, specifically ClinicalTrials.gov, up to date. This includes ensuring that all study results are entered in accordance with the requirements set by the website.
Action
To address this, monthly checks and updates of the studies are performed to guarantee that the records remain current at all times. Upon completion of each trial, the format of the Clinical Study Report’s tables, figures, and listings is adjusted as necessary to comply with the platform’s specifications.
Outcome
As a result, the Sponsor’s study results are made publicly available, reflecting transparency to the wider scientific community and ensuring compliance with regulatory standards.
Issue
At a clinical research site in Ghana, all clinical waste, including unused or expired drug products, was being disposed of by burning in an artisanal wood burner. This practice was unacceptable both from an environmental perspective and in terms of proper tracking and documentation required for good clinical practice.
Action
Discussions were held with the site personnel to explore possible solutions. Subsequently, funding was provided for the installation of a modern and environmentally friendly incinerator. Additionally, a Standard Operating Procedure (SOP) was developed, and comprehensive training was given to the site staff to ensure correct and consistent use of the new system.
Outcome
This capacity-building initiative enabled the site to manage clinical waste in an environmentally responsible and regulatorily compliant manner. As a result, the site demonstrated greater professionalism, which attracted increased interest from sponsors for future clinical trials.
Issue
A Swiss sponsor requested that an outdated Risk Assessment Tool be updated so it would comply with the latest Good Clinical Practice (GCP) requirements. This situation indeed created potential risks for regulatory compliance and the overall effectiveness of study risk management procedures.
Action
To address this, a more current system was developed that incorporated the most recent regulatory guidelines. A new Standard Operating Procedure (SOP) was drafted, and training sessions were conducted for the study teams. This training ensured that feedback and insights from all stakeholders were captured, supporting the thorough implementation of the updated risk management process.
Outcome
As a result of these improvements, the sponsor is now fully compliant with study risk management standards. The organisation is now well-prepared for inspections or audits and is able to respond more swiftly and effectively if any risk materialises during the course of a study.