We have a highly skilled team with many years of experience in the field of unicentre and multicentre trials, national and international, in any of clinical trial phases (Phase I to Phase IV).
- PREPARATION OF INVESTIGATIONAL MEDICINAL PRODUCT Dossiers (IMPD) and CLINICAL TRIAL APPLICATIONS:
- Ethical Committees.
- Spanish Drug Agency.
- STUDY DESIGN AND PREPARATION OF PROTOCOLS.
- MONITORING OF CLINICAL TRIALS by highly qualified staff.
- PREPARATION AND REVIEW OF SOPs for the monitoring of clinical trials according to GCP guidelines.
- SPECIALISED TECHNICAL CONSULTANCY covering all items concerning Phase I, II, III and IV clinical trials related to:
- Spanish, European Union and USA regulations.
- Research centres and investigators.
- TRAINING OF MONITORS to ensure that clinical trials are performed according to GCP.
- WRITING OF FINAL AND INTERIM REPORTS.
- WRITING OF PUBLICATIONS, POSTERS AND PRESENTATIONS TO CONGRESSES, including translations to any language required.
- SPECIALISED TECHNICAL TRANSLATIONS of protocols, investigator brochure, CRF, etc.
Our experience includes:
- Hepatic and renal transplant.
- HIV.
- Vascular neurology.
- Cardiovascular.
- Gastroenterology.
- Rheumatology.
- Microbiology.
- Dermatology.
- Alzheimer’s disease.
- Immunology.
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