Multinational clinical trials Phase I to Phase IV
Appletree CI Group offers performance of clinical trials from Phase I to phase IV…
Consulting
As a full service clinical CSO, we are familiar with all aspects of clinical development and regulatory affairs of drugs and medical devices. Our consulting services cover the whole product life-cycle; from development over marketing authorization and life-cycle management to withdrawal of the product from the market.
Clinical consulting:
- Development planning
- Development of study design, protocol
- Sample size calculation
- Statistical consulting
- Clinical sites and investigators database
- Study placement and patient population availability
- Development cost estimates
Regulatory Consulting:
- Development of regulatory strategy
- Marketing authorization applications
- Liaison with regulatory authorities, preparation of pre-submission meetings, preparation briefing packages and application forms,
- Orphan drug applications with EMA and FDA
- Variations of existing marketing authorizations, European type IA/IB, II, notifications
- Renewals and extensions
- Centralized procedures, abbreviated procedures
- CMC writing, update of quality dossier, CTD module 3
- Advice for Advanced Therapeutics Medicinal Products (ATMP) procedures
- Regulatory evaluations for medical device, combination or borderline products
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Regulatory and Clinical Writing
Our medical writing services include the entire range of documents needed to conduct…
Biostatistics
Professional statistical analysis is an essential component in well-designed and succ…
Devices pre- & post-marketing studies
Regulatory and operational requirements for clinical investigations of medical device…
Clinical trial authorizations Europe
Appletree CI Group offers clinical trial authorization services all over Europe….
Legal representation Switzerland and EU
According to the regulations, Sponsors without legal residence in the EU or Switzerla…
QA/QC
Our quality assurance and quality control processes ensure adherence of our operation…
Registry services
We can support you in design of a lean solution which can satisfy both treating physi…
