Detailed Rare Disease Insights: How TrialHub’s Data Reduced Timelines for Bionical Emas to Plan for a Phase 4 Tuberous Sclerosis Complex Trial

Detailed Rare Disease Insights:
How TrialHub’s Data Reduced Timelines
for Bionical Emas to Plan for a Phase 4 Tuberous Sclerosis Complex Trial

Rare disease clinical trials present an additional challenge for feasibility teams; selecting the right site locations requires highly specialized data given the low, often geographically spread prevalence and potentially limited clinical expertise. Experienced sites with the capacity to conduct such studies can be hard to identify. Additionally, with Phase 4 studies, the local reimbursement and standard of care landscape may need to be understood, which can present an added hurdle to country selection if not considered from the start.

Bionical Emas Phase 4 Tuberous Sclerosis Case Highlight

Instant Insights

Reduced country selection time by: 

0 %

State-of-the-art algorithm –
for a robust strategy

The Client

Bionical Emas is the only Contract Research Organization (CRO) to combine Clinical Development, Clinical Trial Supply (CTS), and Early Access Programs (EAP) to bring life-changing medicines to patients around the world. Their unique integrated business model, with its range of services and capabilities, benefits many of the world’s leading pharma and biotech companies. This distinctive offering enables them to maximize access and generate evidence at every stage of the drug development pathway.

The Challange

A request to identify potential sites for a Tuberous Sclerosis Complex Phase 4 study. 

The treatment being investigated has regulatory approval/commercial availability in some of the countries being considered for the clinical trial but not in all of them. In the countries where the treatment does not yet have regulatory approval, the study would be considered a phase 3 trial, not phase 4. In the countries where the treatment is commercially available for use, patients may already be able to obtain access, presenting a potential barrier to recruitment.

The Approach

TrialHub is an NLP and AI-powered data intelligence platform dedicated to empowering clinical trial strategists with real-time insights on patients, sites, competition, and regulations. The platform covers all indications, including rare diseases.

On top of that, TrialHub’s Standard of Care module efficiently offers insights about reimbursement status, data which is often time consuming to research and compile, which further aided country selection. To propose specialized sites for the study, Bionical Emas used TrialHub’s filters and quickly identified organizations with relevant experience and internal capacity.

Whereas previously their feasibility research required a significant amount of manual searching, with TrialHub, Bionical Emas were able to obtain a wealth of accurate, pre-validated real-time data in a matter of a few clicks. This opened up more time for their team to engage in strategic planning and operational considerations.

The Outcome

TrialHub’s data on enrollment and timelines, as well as disease prevalence, reduced the time it took for Bionical Emas to identify and suggest additional countries to the sponsor by 50%. 

TrialHub’s robust database quickly provided Bionical Emas with the crucial insight needed to determine the country strategy for this Rare Disease Clinical Trial.

TrialHub’s intelligence, powered by state-of-the-art algorithms, combined with Bionical Emas’s internal expertise, solidified the study design and enabled Bionical Emas to provide a robust strategy to the sponsor. 

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