With a truly patient-focussed approach we offer a best-in-class Early Access Program service that ensures patient, healthcare professional, and client needs are met through passionate and tailored program delivery.
Sourcing commercial drug products for clinical trials can be a complex process and is often one of the last considerations during study design. Our experienced Global Sourcing Team is uniquely positioned to support you through the commercial drug sourcing process with their deep understanding of clinical trials and commercial drug markets.
Focused on delivering clear and concise biostatistics and programming expertise to ensure the data analysis of your trial is produced accurately, efficiently and on time.
Our Biostatistics and Clinical Programming Team has extensive industry experience in a variety of therapeutic areas, including extensive interactions with regulatory agencies, development support, strategy planning and expediting the approval process. We add value to study teams by bringing technical expertise to projects of all sizes, from small first-in-human trials to large multinational studies.
‘We add value to study teams bringing technical expertise to projects of all sizes.’
From the inception of a study to final reporting, statistical consultancy is key to a study design fit for purpose that meets all the study objectives and focuses on the endpoints alongside ICH compliance. Our statisticians offer experience in various study designs (including adaptive and Bayesian designs), sample size estimation, handling of missing data and combining trials for ISSs and ISEs. This level of expertise is demonstrated through the development of the Statistical Analysis Plan (SAP) text and TFL shells which will describe the methods to be used to analyze, summarize and present the data. Our statisticians collaborate with medical writers and scientific experts to ensure the appropriate interpretation of study results.
Working with a top 20 pharmaceutical company to guide the evolution of their public policy for providing pre-approval access to gene therapy.
Delivering savings, sustainability and expedited timelines through our UniQ™ supply process.
Facing a high unmet need and a history of challenges around early access to treatments.
Discover more about the services and capabilities Bionical Emas has to offer
