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If 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

• Papers

• Posters

Medical Articles
• 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.
• If you need, we offer review of procedures

• High level control

• Site Audit preparation

• IRBs