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Clinical Trials
Other studies
Registers
Medical Writing
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- Ethics Committee submission and management.
- AEMPS (Spanish Agency) submission and management
- Global Project Management
- Protocol development and CRF design
- Investigators and sites selection
- Meetings with investigators
- Monitoring
- Follow up and report on Serious Adverse Events
- Final clinical report
- CRAs training
- Protocol design support
- CRF design
- Database design and set-up
- Data Entry
- Data Entry validation. Checks and Superposition (second entry)
- SAS Programming (v 9.1)
- Development of query resolution conventions
- Quality Control of Database. Database lock (Clean Database)
- Global Database integration
- Data Management report
- Protocol and CRF design support
- Study design
- Statistical Programming Plan and Statistical Analysis Plan (SAP)
- Sample size calculation
- Randomisation
- Intermediate analysis
- Statistical programming, SAS. Programing and Validation report
- Statistical Analysis and Validation
- Statistical Report
- Support in preparation of articles,presentations,posters ...
- Trainings (statistical software, basic statistics, trials design)
- Pharmaeconomy
- Experimental (cross-over study...)
- Observational (cohort study, cases-control studies, cross-sectional study)
- Epidemiology
- Quality of life scales
- Meta-analysis
- Multivariate analysis
- Operative Investigation
- Surveys
- Medical articles
- Other Publications
- Abstracts and Posters
- Lectures and Presentations
- Protocol an CRF design
- Clinical Trial report
- Staticial report
- Summary of Product Characteristics
- Leaftes
- National procedure applications: strategic advice / liaison with regulatory authorities
- Mutual Recognition, Decentralised and Centralised Procedure Applications
- Development of registration applications
- Line Extensions applications and applications for variations and renewals
- Dossiers evaluation
- Updating of existing registration files or documents (e.g. SmPC, PIL and labelling)
- Translating of technical texts, Spanish / English / other languages
- Prices and reimbursement
- Medicinal Products, including OTC products and Generics.
- Orphan drugs
- Cosmetics
- Medical devices
- Veterinarian products and medicines
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