Strategic Clinical Oversight for Global Real-World Evidence (RWE)
UK Hospitals
Hospital Staff Relationships
Years of Experience
While our interventional portfolio is extensive we have developed a significant capability in the design and execution of Real-World Evidence (RWE) programmes. Operating as a global CRO based in the UK, we support sponsors in bridging the gap between controlled clinical trials and the practicalities of patient care. We partner with biotech and pharmaceutical firms to generate robust, longitudinal data sets that satisfy global regulatory bodies and healthcare payers, ensuring that a product’s value is demonstrated in real-world clinical settings.
Capturing the Patient Journey with Natural History Studies
A cornerstone of our RWE offering is the management of Natural History Studies.
In many therapeutic areas—particularly rare diseases and progressive conditions, understanding the standard disease trajectory is essential for benchmarking future therapies.
We design these non-interventional frameworks to capture long-term patient outcomes, disease milestones, and treatment patterns.
These studies are not just observational; they provide the vital evidence base needed to inform trial design, support orphan drug applications, and can even serve as synthetic control arms.
Expert Site Selection and Global Data Intelligence
Executing an RWE study requires a deep understanding of how data is recorded across different healthcare systems.
Through our experience with UK, European, and North American sites, we identify the specialist clinics and registries that maintain the most comprehensive longitudinal records.
Our advantage comes from knowing how to navigate the diverse governance and privacy requirements of different regions.
We know which centres have the administrative agility to participate in long-term observational research and which databases offer the highest quality data for specific indications.
By working with us, you gain access to this global intelligence, ensuring your study is placed where the data is most robust and the investigators are truly engaged in long-term patient tracking.
Coordinating Complex Data and Patient Registries
RWE trials depend on the consistency and longevity of their data. We specialise in synchronising requirements, including Electronic Health Record integration, patient-reported outcomes (PROs), and the collection of real-world biomarkers, across international sites.
We act as the vital link between the sponsor, the clinical sites, and the data analysts, ensuring that every data point is captured with the precision required for global regulatory scrutiny.
Frequently Asked Questions
What range of services do you provide for RWE?
We offer a full-service model including study design, registry development, regulatory submissions, and global site management. Our support focuses on capturing real-world safety and effectiveness to support market access and regulatory requirements.
How do you help sponsors select the right global sites for RWE?
Because we know the UK, European, and US site landscapes so intimately, we guide sponsors toward locations that have the best infrastructure for long-term data collection, focusing on sites with high-quality electronic records.
Can you handle the regulatory hurdles for global observational studies?
Yes. Our team is well-versed in the specific data privacy requirements of RWE, including GDPR in Europe and HIPAA in the US. We manage the submissions needed to ensure that global data collection meets all local legal and ethical standards.
How do you ensure data quality in a non-interventional setting?
We implement rigorous data-validation processes. By working closely with site coordinators and using standardised data-capture tools, we ensure that information extracted from real-world settings is as reliable as data from an interventional trial.
What makes your project teams different from a large, generic CRO?
Continuity. In RWE research, where understanding the long-term patient journey is critical, having the same senior experts from planning through to close-out prevents data gaps and ensures a consistent narrative.
Do you support companies with natural history data for synthetic controls?
Absolutely. We manage the studies that provide the foundational data for synthetic control arms, providing the framework needed to capture real-world evidence that can be used to augment or benchmark interventional results.
Case Study: Navigating Global Complexity in Real-World Evidence
In the landscape of antimicrobial resistance, clinical reality is far more complex than the controlled environment of a trial.
Patients requiring last-line therapies are often critically ill with multiple comorbidities, yet capturing their data globally presents a logistical and regulatory minefield.
As the CRO, one substantial contribution was managing the "not straightforward" intersection of country-specific regulations and site-specific data requirements.
Because RWE relies on existing medical records, we had to build a bespoke data extraction framework that accounted for inconsistent record-keeping across international hospital systems.
This wasn't a one-size-fits-all approach; each country presented unique ethical and legal hurdles.
We navigated the divergent interpretations of GDPR in Europe versus HIPAA in the US, ensuring that every data point was captured without compromising stringent patient confidentiality or local privacy laws.
The complexity deepened at the site level. We managed the arduous task of coordinating with individual institutional review boards (IRBs) and ethics committees, each with their own specific demands for data governance and patient consent.
By establishing a rigorous, pre-specified protocol, we mitigated the risks of "data missingness" and bias that often cause regulators to dismiss retrospective studies.
Our team worked directly with sites to ensure that the transition from unstructured clinical notes to a structured, auditable evidence package met the high evidentiary standards required by the FDA and EMA.
Beyond data collection, we provided the strategic nuance needed to overcome "salvage bias." By categorising usage into documented, empiric, and salvage therapy, we demonstrated that earlier intervention led to a 72% clinical cure rate in bloodstream infections.
This technical distillation was critical for the data's successful presentation at IDWeek 2025. Ultimately, our contribution was not just in managing a study, but in building a robust regulatory and ethical bridge that allowed real-world clinical success to be recognised as high-quality scientific evidence