BioPharma

Your full-service partner in Expanded Access Programs

Backed by over a decade of experience in expanded access, we support in the design, execution, and close-out of Expanded Access Programs (EAPs), tailored to fit any clinical program and market access strategy.

 

Our services

Strategic consultancy

Utilize our broad experience in framework & infrastructure development, change management, and EAP strategy & program optimization.

Regulatory intelligence

Tap into deep expertise across regulation, reimbursement and global practical know-how, enabling compliance with country specific regulations.

Site management services

Get hands-on support from our medically-trained site managers who handle all incoming requests from HCPs and streamline the entire EAP process.

Supply chain & logistics

Run global product distribution through our compliant (GAMP 5 Part 11) and integrated order management system.

Real-World Data (RWD)

Collaborate with our industry-leading RWD team to design, execute, and analyze your RWD projects.

Integrated platform

Access key insights for requests, orders, and data collection through our ISO 27001-certified platform and integrated EDC system.

“We’ve been impressed by the dedication of our myTomorrows colleagues and their rapid response and engagement with requesting institutions. Treating physicians have been uniformly positive in their comments on myTomorrows.”

Steve Whitaker – Chief Medical Officer

Omeros

“myTomorrows guided us through the set-up stage and while the program is running myTomorrows provides valuable suggestions for our consideration pro-actively, and thus contributing to our decision-making in the program.”

AiCuris team

AiCuris

Our approach

At myTomorrows, we focus on four key areas to create a tailored EAP delivery plan that strategically aligns with your clinical development goals and organizational needs.

Startup

Company preparedness

We perform a gap analysis on current processes, set up a framework and infrastructure for EAP delivery, and provide educational materials and change management support for your EAP strategy.

Planning

Product-specific planning

We help design country-specific roadmaps, timelines for program initiation, and any operational considerations, including exit strategies per target country.

Execution

EAP delivery

We develop an EAP delivery plan that seamlessly integrates with your organization minimizing internal resource strains whilst ensuring operational excellence. Implementation is backed by our proprietary platform which includes custom reporting for full visibility.

Close-out

Transition management

For post-trial access, we ensure a smooth transition from clinical trials to EAP, minimizing treatment interruption. Furthermore, we facilitate the shift from EAP to licensed product, supporting your teams and patients for a timely transition.

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Our commitment to operational excellence

“Being a team of medical professionals with clinical experience, we empathize with the daily challenges physicians face and highly value their time.” – Natalia Coptu, MD, Site Manager Lead – Ex-PV specialist at IQVIA.

Get in touch

Discover our other BioPharma services

Real-World Data (RWD)

Discover how our industry-leading RWD team supports the design, collection, and analysis of RWD for patient registries, non-interventional studies and full-scale EAPs.

Patient recruitment

Explore our patient-centric clinical trial recruitment services, including automated pre-screening for high-quality patient referrals.

Get in touch

 

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"After over a decade in large pharma, I joined my Tomorrows to combine a high-purpose job with a more agile, hands-on environment. At myTomorrows, we view Regulatory Affairs as key to unlocking the full potential of EAPs and their potential to support underserved populations globally."

Daniele Tagliente, PharmD - Director Regulatory Affairs & Pharmacovigilance at myTomorrows