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Heathics Paris France, pharmaceutical industry consultant, pharmaceutical laboratory consultant team,  study, trial, consultant, paediatric investigational plan, registration files ctd,

Heathics Paris France, pharmaceutical industry consultant, pharmaceutical laboratory consultant team,  study, trial, consultant, paediatric investigational plan, registration files ctd,
Heathics Paris France, pharmaceutical industry consultant, pharmaceutical laboratory consultant team,  study, trial, consultant, paediatric investigational plan, registration files ctd,
  pharmaceutical industry consulting in France, pharmaceutical laboratory consulting, drug safety, clinical study, medical market consultants, scientific communication consulting,
 





medical market consultant, pharmaceutical laboratory consultancy

Pharmaceutical development , consultant, pharmaceutical laboratory consultancy

Non-clinical development, consultant, pharmaceutical laboratory consultancy

clinical development study trial consultant

Drug safety and pharmacovigilance, consultant, pharmaceutical laboratory consultancy

paediatric investigational plans pip

Drug dossier submission, authorities registration files ctd

medical market access support



Clinical development plans must be consistent with regulatory strategy and competitive environment. Unmet medical needs and evolving clinical practice are key drivers for the definition of study objectives aiming to demonstrate therapeutic benefit. Clinical studies must take into account available non clinical and clinical data that may be predictive of the benefit-risk balance of the future approved medicinal product.

We assist you in developing such plans with adequate methodological, academic and logistical support with the purpose of best documenting the medicinal product therapeutic added value.
Our contribution to the robustness of the trials methodology includes the development of clinical study outlines and protocols with adequate selection of patient populations, sample size calculation, procedures and endpoints and statistical analysis plan while ensuring that overall design is consistent with study objectives.
We organise trials scientific management with supportive boards of experts: Executive and/or Steering Committees, Data and Safety Monitoring Committees, Endpoint Validation Committees and corresponding charters.
When needed, we assist you in the selection, contract negotiation and management of Contract Research Organisations (CROs) dedicated to Clinical Operations.
Our contributions also include the interpretation of study results and the completion of Clinical Study Reports (CSR) in ICH format.

Heathics Paris France, pharmaceutical industry consultant, pharmaceutical laboratory consultant team,  study, trial, consultant, paediatric investigational plan, registration files ctd,




Heathics
111, rue des Tennerolles - 92210 Saint Cloud, France
Phone/Fax : 33+ (0)1 46 02 19 30.


Links


Conception - réalisation
lagencecdrs.com