Advisory
Scientific advice
Evidence generation
JCA dossier
Local HTA
Is your organisation ready for Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA)?
Our advisory services help you incorporate JCA into strategic decision-making and optimise your current ways of working in line with JCA requirements.
Advisory
JCA impact assessment on portfolio
Operating model design
Pricing & market access strategy
Governance and standard operating procedure (SOP) development
External stakeholder engagement strategy
Readiness assessment, incl. peer benchmarking
Tracking of JCA key performance indicators (KPIs)
JSC/JCA training development and roll-out
Change management and project management office (PMO) support
Is your asset eligible for Joint Scientific Consultations (JSC)? You need to prepare for scientific advice meetings, and then incorporate the advice into your evidence generation planning?
We help you get the most out of scientific advice opportunities, from strategic planning to briefing book development and trial design optimisation.
Scientific advice
JSC/G-BA/HAS/NICE/CADTH eligibility assessment, incl. joint regulatory advice options
Trade-off analysis and strategic planning for scientific advice
Application and briefing book development
Advice meeting preparation and support
Advice meeting debrief and strategic recommendations for pivotal trial design
Are you collecting the right evidence for your asset to ensure future Joint Clinical Assessment (JCA) success?
Our team supports you anticipate PICOs, develop and execute all aspects of JCA evidence generation strategy, to ensure you have the evidence you need.
Early PICO simulation (AI-assisted), prioritisation and JCA strategy development
Evidence generation strategy development, incl. gap analysis
JCA Statistical Analysis Plan development
Execution of JCA evidence generation strategy, incl.
Evidence generation
o Systematic literature review (AI-assisted) o Indirect treatment comparison o External comparator studies o Post-hoc analyses
Global value dossier development
You need support developing your JCA dossier, to ensure methodological requirements and timelines are met?
We provide end-to-end JCA services, from strategy development to JCA dossier writing, and post-submission support.
Final PICO simulation (AI-assisted) and JCA dossier strategy development
Dossier development support, from early draft to post-submission (AI-assisted)
Objection handling for non-addressed PICOs/JCA report
JCA dossier
How to best align Joint Clinical Assessment (JCA) and local launch preparations? What is needed to ensure local HTA success?
Our on-the-ground market experts help you define country-specific post-JCA strategies, support delta dossier development, complementary analyses, model development and adaption, as well as price negotiations.
Delta dossier landscaping and mapping
Local external engagement mapping
Local PICO simulation and country-specific post-JCA strategy
Delta dossier development and complementary analyses
Mock HTA meetings and meeting attendance
Post-submission full pricing & reimbursement (P&R) support and negotiation
Local HTA
JCA impact assessment on portfolio
Operating model design
Pricing & market access strategy
Governance and standard operating procedure (SOP) development
External stakeholder engagement strategy
Readiness assessment, incl. peer benchmarking
Tracking of JCA key performance indicators (KPIs)
JSC/JCA training development and roll-out
Change management and project management office (PMO) support
Is your organisation ready for Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA)?
Our advisory services help you incorporate JCA into strategic decision-making and optimise your current ways of working in line with JCA requirements.
Advisory
JSC/G-BA//HAS/NICE/CADTH eligibility assessment, including joint regulatory advice options
Trade-off analysis and strategic planning for scientific advise
Application and briefing book development
Advice meeting preparation and support
Advice meeting debrief and strategic recommendations for pivotal trial design
Is your asset eligible for Joint Scientific Consultations (JSC)? You need to prepare for scientific advice meetings, and then incorporate the advice into your evidence generation planning?
We help you get the most out of scientific advice opportunities, from strategic planning to briefing book development and trial design optimisation.
Scientific Advise
Early PICO simulation (AI-assisted), prioritisation and JCA strategy development
Evidence generation strategy development, incl. gap analysis
JCA Statistical Analysis Plan development
Execution of JCA evidence generation strategy, incl.
Early PICO simulation (AI-assisted), prioritisation and JCA strategy development
Evidence generation strategy development, incl. gap analysis
JCA Statistical Analysis Plan development
Execution of JCA evidence generation strategy, incl.
Early PICO simulation (AI-assisted), prioritisation and JCA strategy development
Evidence generation strategy development, incl. gap analysis
JCA Statistical Analysis Plan development
Execution of JCA evidence generation strategy, incl.
Are you collecting the right evidence for your asset to ensure future Joint Clinical Assessment (JCA) success?
Our team supports you anticipate PICOs, develop and execute all aspects of JCA evidence generation strategy, to ensure you have the evidence you need.
Evidence generation
Final PICO simulation (AI-assisted) and JCA dossier strategy development
Dossier development support, from early draft to post-submission (AI-assisted)
Objection handling for non-addressed PICOs/JCA report
Execution of JCA evidence generation strategy, incl.
You need support developing your JCA dossier, to ensure methodological requirements and timelines are met?
We provide end-to-end JCA services, from strategy development to JCA dossier writing, and post-submission support.
JCA dossier
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