What we offer


Advising and medical writing
Study Protocols
Design of Case Report Forms
Literature Reviews
Conference Materiales (Abstracts, poster presentation and slide sets)
Technical consultation to AEMPS
Development of study proposals
Clinical Study Reports / Clinical Trial Reports
Manuscripts
Summary of Product Characteristics
Scientific Documents (medical marketing reviews, educational material, etc.)
Regulatory Affairs
Submission to Ethics Committees and Health Authorities (local & central)
Preparation and gathering of essential documents
Insurance Policy processing
Site contracting negotiations
Monitoring
Selection of Investigators
Training of the investigational team
Creation and maintenance of archives
In-site monitoring visits and report writing
Secondary and phone monitoring activities
Report creation
Drug management: supply, accountability, destruction
Sample management
Contact with investigators, recruitment encouraging
Follow up and resolution of queries
SAE management
Statistics
Design and implementation of systematic revisions and meta analysis
Randomization selection/sample allocation
Development and design of statistical tools for protocols
Sample size justification
Definition and preparation of the statistical analysis plan
Development of statistical reports
Development and validation of questionnaires
Analysis of surveys
Statistical training
Data management
e-Clinical (electronic CRF)
Data cleansing and validation
Pharmacovigilance
Safety Registries
SAEs and SUSARs assessment
Expeditious notification
Writing of DSUR and PSUR
Review of the safety section of protocols