Early Access Programmes and Real-World Data Collection
The team at Boyds has built a reputation for providing expertise into the design and launch of early access programmes (EAP) with real-world data (RWD) collection.
We work across the globe to provide strategic advice and guidance to enable the delivery of EAPs and RWD collection, providing clear guidance on regional and country-specific requirements, protocol writing and ensuring alignment with regulatory and ethics committee/review board expectations.
Our team, comprised of experts in the EAP and RWD fields, will work with you to provide strategic insights and clear documentation to maximise the value of your EAP and RWD programme, whilst ensuring, in parallel, that life-saving medicines can be provided efficiently to patients with limited treatment options.
The team at Boyds will ensure that your EAP and RWD programme does not hinder or compromise your clinical development plans, ongoing clinical trials or marketing authorisation applications (MAA) plans in a specific geographic territory.
We support clients in developing an RWD and EAP data collection strategy that aligns with their corporate objectives and ensures that the data to be collected is of sufficient quality for use in regulatory submissions and publications.
Boyds provides unparalleled expertise to help our clients make best-use of the data obtained EAP & RWD programme.
Examples of best-use include ensuring that the data obtained from an EAP and RWD programme:
- Meets the expectations of the regulators and health technology assessors / payers.
- Provides insights into the disease being studied to inform clinical trial design
- Allows the further characterisation of the long-term safety of an IMP
- Provides exploratory clinical outcomes in the real-world setting
- Characterises the size of the patient population (disease prevalence)