Global Oncology Phase 3 Rescue Study
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Real World Evidence
Our solutions are designed with current and future patients in mind.
Our solutions are designed with current and future patients in mind.
Real World Data (RWD) routinely collected on patient health and/or the delivery of care from sources other than clinical trials continues to play an increasing role in healthcare decision-making. The analysis of RWD provides an opportunity to generate Real World Evidence (RWE) capable of supplementary insights on the usage, potential benefits/risks and value proposition of medicinal products and medical devices.
‘The analysis of Real World Data provides an opportunity to generate Real World Evidence.’
Regulatory Authorities and Health Technology Assessment (HTA) bodies primarily base recommendations on conventional clinical trials. However, increasingly for both initial assessment and initiatives such as outcomes-based agreements, wider datasets are being recommended and utilized throughout the decision-making process.
Our organization prides itself on powering the patient journey by bringing life-changing medicines to patients around the world. Incorporating regulatory or HTA scientific advice and engaging with our global Patient Advocacy Team, Bionical Emas can design and deliver well-designed RWE solutions capable of fulfilling requirements and supplementing the evidence-generation plan.
Our Data Services department is experienced in creating robust solutions involving the collection and application of data. With established processes alongside a highly configurable unified cloud-based platform, our tailored solutions offer real-time reports and ensure 21CFR Part 11 compliance. As such, Bionical Emas can deliver all aspects of RWE generation with quality and precision.
Bionical Emas offers a range of additional in-house end-to-end capabilities including data management, clinical programming, biostatistics, medical writing and pharmacovigilance functions for input into the design, collection and reporting of the defined data required. These services can be refined dependent on the level of support required. For example, our clinical programming and biostatistical services can provide protocol input, creation of the Statistical Analysis Plan (SAP), statistical analysis/reporting and provision CDISC compliant SDTMs and ADaMs datasets with associated documentation.
Although the primary goal of an Early Access Program (EAP) is to provide access to treatment, generating RWE is becoming increasingly valuable for regulatory and reimbursement insights, with evolving frameworks for utilization in the decision-making matrix.
At Bionical Emas, we believe that RWD collection should form a core part of any EAP and endorse its collection as a standard part of our offering. This is due to the unique opportunity an EAP affords to collect data ahead of commercial launch, particularly pertinent in the context of oncology, hematology and rare disease, where there is an enhanced requirement for vital intelligence.
If incorporated with appropriate design, consent and regulatory consideration, collection can yield numerous insights, including the potential to supplement marketing authorizations and HTA submissions. While respecting local data collection regulations, Bionical Emas aligns to the evidence and outcome requirements of strategic importance to our partners.