Fast response 24 hours x 7 days
Close collaboration
CRAs in major cities
Very low turnover
Line Management Premium
Project and Management Cost reduction
Local senior CRAs
Immediate Availability
Foreign language skills
CRAs therapeutic specialist
SIV, MV, COV by Seniors CRAs
Studies and reports on the suitability and selection of sites
Contract negotiations by Regulatory Start Up experts
Investigator meetings & conferences
Preparation for a FDA Inspections, Internal-External Audits done by Senior CRAs
Qualifications visits and feasibilities
Bid Defense
CTIS submission and FUP. Regulatory Managers expert in CTIS.(Part I/II)
Ethics committees and Competent Authorities
Clinical trial files preparation and maintenance
Translations done by Certified Translators