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Integrated Evidence Generation Planning
Integrated Evidence Generation Planning
One cross-functional plan connecting every study to the decision it supports.
One cross-functional plan connecting every study to the decision it supports.
One cross-functional plan connecting every study to the decision it supports.
Evidence programmes are commonly assembled one study at a time, by the function that needs it, without a single view of whether the resulting portfolio answers the questions the product will face.
An integrated evidence generation plan brings cross-functional teams together to build one plan before design choices are locked in.
The Evidence Landscape
The Evidence Landscape
The Evidence Landscape
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external control arms in oncology were accepted in German HTA assessments between 2021 and 2023, compared with 41% in England.
Monnereau et al. 2025; British Journal of Cancer
external control arms were accepted without restriction by European health technology assessment bodies in oncology between 2021 and 2023.
Monnereau et al. 2025; British Journal of Cancer
external control arms in oncology were accepted in German HTA assessments between 2021 and 2023, compared with 41% in England.
Monnereau et al. 2025; British Journal of Cancer
38%
38%
38%
of manufacturers cited an evidence package unlikely to meet country requirements as their reason for not filing for pricing and reimbursement in the EU and UK.
Charles River Associates - European Access Hurdles Portal, May 2025
How we support you.
How we support you.
How we support you.
We start with the claims your product needs to support and work back to the evidence each one requires.
Through a facilitated cross-functional workshop, we bring together the relevant teams, including clinical development, biostats, health economics and outcomes research, medical affairs and commercial, to define those claims and agree where the evidence will come from.
Where trials or studies are already underway or planned, we factor them into the plan so new work complements them rather than repeating them.
From there, we identify evidence generation opportunities across the product lifecycle, before and after launch, from dose optimisation and population broadening through to comparative effectiveness and real-world evidence for value and access.
Each initiative is defined individually and developed through a facilitated cross-functional workshop.
We work with relevant teams, including health economics and outcomes research, medical affairs and commercial, to identify the claims a product needs to support.
From there, we identify evidence generation opportunities across the product lifecycle, before and after launch, from dose optimisation and population broadening through to comparative effectiveness and real-world evidence for value and access.
We start with the claims your product needs to support and work back to the evidence each one requires.
Through a facilitated cross-functional workshop, we bring together the relevant teams, including clinical development, biostats, health economics and outcomes research, medical affairs and commercial, to define those claims and agree where the evidence will come from.
Where trials or studies are already underway or planned, we factor them into the plan so new work complements them rather than repeating them.
From there, we identify evidence generation opportunities across the product lifecycle, before and after launch, from dose optimisation and population broadening through to comparative effectiveness and real-world evidence for value and access.
Current and planned evidence mapped against regulatory, assessment and payer requirements.
Claims framework linking each claim your product needs to support to the evidence it requires.
Facilitated cross-functional workshops bringing the relevant teams together to agree priorities.
Written evidence generation plan, sequenced across the product lifecycle.
Current and planned evidence mapped against regulatory, assessment and payer requirements.
Claims framework linking each claim your product needs to support to the evidence it requires.
Facilitated cross-functional workshops bringing the relevant teams together to agree priorities.
Written evidence generation plan, sequenced across the product lifecycle.
Related Services
Related Services
Related Services
Usually works alongside an evidence gap assessment and can lead into study design, protocol development, and patient reported outcomes.
Usually works alongside an evidence gap assessment and can lead into study design, protocol development, and patient reported outcomes.
Take Real-World Research Further
If you would like to discuss a programme, please get in touch.