Services to Pharmaceutical companies
A seasoned consultant based on years of experience
Strategic services
Advise on RWD/RWE enterprise strategy and organisation to maximize ROI.
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Advise on advanced analytics needs and positioning vs ROI.
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Advise on how to develop an integrated and comprehensive evidence generation strategy throughout the drug lifecycle.​
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Facilitate key networking with Regulators, HTA bodies, Academic KOLs, RWD sources (e.g. EHR, EMR, claims, hospitals and registries in rare diseases and pediatrics).
Scientific services
Act as subject matter expert in RWE, ensuring appropriate and principled use of RWD and RWE.
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Review and enrich product/portfolio evidence generation plans.
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Advise on data sources and provide data landscaping which is fit for purpose.
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Act as pharmacoepi. senior advisor; incl. study design, protocol review (e.g. PASS, PAES, comparative designs).
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Join study advisory boards (e.g. in complex multi-country PASS, PAES, ECA studies).
Regulatory (& HTA) services
Provide advice on Pharmacoepidemiology & RWE regulatory best practices (existing guidelines and requirements in dossiers).
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Provide advice on RWE strategy supporting Marketing Authorization and/or HTA dossiers.
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Act as senior advisor of the design of regulatory/decision-grade RWE studies (e.g. PASS, comparative effectiveness studies).
Services to CRO, HealthTech,
Data owners and Startups
A seasoned consultant based on years of experience
Strategic services
Facilitate the RWD-RWE landscape understanding and pharma needs.
​
Advise on RWD/RWE enterprise strategy and organisation to maximize ROI.
​
Advise on advanced analytics needs and positioning vs ROI.
​
Facilitate key networking with Pharma peers, Regulators, HTA bodies, Academic KOLs, RWD sources (e.g. EHR, EMR, claims, hospitals and registries in rare diseases and pediatrics).
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Act as business contributor - Company growth.
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Join company boards / Board of directors.
Scientific services
Act as pharmacoepi. senior advisor/subject matter expert in RWE:
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to enrich proposals and solutions to pharma clients
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to join bid meetings
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to enrich evidence generation plan development
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to advise on data sources and provide data landscaping which is fit for purpose
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to define/enrich study designs
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to review protocols and various client deliverables (e.g. results, reports, publications)
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to join study advisory boards (e.g. in complex multi-country PASS, PAES, ECA studies)
Regulatory (& HTA) services
Act as senior advisor on regulatory requirements:
-
provide advice on Pharmacoepidemiology & RWE regulatory best practices (existing guidelines and requirements in dossiers).
-
provide advice on RWE strategy supporting Marketing Authorization and/or HTA client dossiers.
-
provide senior review of the design of regulatory/decision-grade RWE studies (e.g. PASS, comparative effectiveness studies).