More Website Templates @ TemplateMonster.com - March 10, 2014!
ServicesIf you need….Reliable & Responsible Team, Adherence to National & International Guidelines, Access to Latin America networks, Experienced, well trained & friendly CRAs. Contact Fractals
Monitoring & Trial Management• Global Research Management.
• Feasibility Questionnaires.
• Proposal for sites and Principal Investigators.
• Contract agreements with. Investigators and providers needed for the study.
• Procuring regulatory documents, both, national and international.
• Revision and document translation.
• Design, organization and maintenance of Site Research File and Master File.
• Investigators´ meetings organization.
• Monitoring & Co-Monitoring visits.
• Monitoring and logistics of bio-equivalency studies.
Regulatory affairs• Protocol & trial documentation submission to health authorities.
• License process of importation/ exportation.
• Liberation of Dept. of Custom materials.
• Review and submission of prescription indications.
• Review and submission of publicity material.
• Substance registration.
• Pharmaceutical vigilance reports.
Medical Writing• Study of document design
• Protocol, CRFs, Informed Consent, Diaries, Site Investigator File , and monitoring manual design of clinical study reports
• Security reports
• News Letters
Pharmacovigilance• Administration of AEs reports
• Sending to sites the international SAEs, and SUAs, CIOMS
• On time reporting to local regulatory authorities MoH
• Follow up of SAEs Reporting; MoH, IRBs & FDA
Training of Clinical Investigators• Training of Clinical Investigators, onsite staff & CRAs, plays a pivotal role in the Clinical Trial Development
• We offer you: Knowledge gathering & Medical Expertise
• Researcher Training
• On Site Staff Training
• Integrated training for Protocol, Informed consent, and all laboratory procedures involved at the clinical Trial level.
• Sample Size Calculation
• Statistical Plan
• Statistical Analysis
Q&A• If you need, we offer review of procedures
• High level control
• Site Audit preparation