Early Evidence Assessment from a regulatory/HTA/payor perspective (US, GER, UK, FR)
Early Evidence assessment that is based on a clinical guideline / HTA review of relevant proxy assets; includes identification of evidence gaps as well as analysis of planned trial design and development of study / evidence generation proposals.
Includes:
Kick-off meeting
Bi-weekly virtual status calls
Clinical guideline review of the target disease in France, Germany, US, and the UK
HTA decision review in France, Germany, and the UK (may also include proxy diseases, if applicable; only decisions that are openly communicated included; ICER review might be done as well) covering 2-3 decisions per country
Analysis of your (planned) clinical trial design
15-20 pages summary presentation summarizing the previous activities as well as our recommendations around trial design & recommended evidence generation
Timeline: 8 weeks
Early Evidence assessment that is based on a clinical guideline / HTA review of relevant proxy assets; includes identification of evidence gaps as well as analysis of planned trial design and development of study / evidence generation proposals.
Includes:
Kick-off meeting
Bi-weekly virtual status calls
Clinical guideline review of the target disease in France, Germany, US, and the UK
HTA decision review in France, Germany, and the UK (may also include proxy diseases, if applicable; only decisions that are openly communicated included; ICER review might be done as well) covering 2-3 decisions per country
Analysis of your (planned) clinical trial design
15-20 pages summary presentation summarizing the previous activities as well as our recommendations around trial design & recommended evidence generation
Timeline: 8 weeks
Early Evidence assessment that is based on a clinical guideline / HTA review of relevant proxy assets; includes identification of evidence gaps as well as analysis of planned trial design and development of study / evidence generation proposals.
Includes:
Kick-off meeting
Bi-weekly virtual status calls
Clinical guideline review of the target disease in France, Germany, US, and the UK
HTA decision review in France, Germany, and the UK (may also include proxy diseases, if applicable; only decisions that are openly communicated included; ICER review might be done as well) covering 2-3 decisions per country
Analysis of your (planned) clinical trial design
15-20 pages summary presentation summarizing the previous activities as well as our recommendations around trial design & recommended evidence generation
Timeline: 8 weeks