Our services attend all steps of the clinical trial reducing timelines and costs. 

  • Developments of clinical protocols phase I, II, III, IV and post-marketing.
  • Design and production of CRFs.
  • Site Qualification and feasibility analysis for best sites selection.
  • Monitoring (pre-study, initiation, monitoring and close-out visits).
  • Informed Consent form design and adequacy to local regulations.
  • Selection and training of Investigators and study coordinators.
  • Interaction with Laboratories (national and international) including the selection and set-up of services.
  • Development of instruction material to sites and laboratories including Investigators and Laboratory Manuals, advertisement materials, patient support materials and others.
  • Preparation and conduct of Investigators’ Meetings.
  • Certified technical translations
  • Preparation of regulatory packages, submission to the Health Authorities and follow-up until approval.
  • Support in the Ethics Committee documents submission.
  • Medical support for serious adverse events (SAEs) and SUSARs.
  • Experienced staff in the importation of clinical supplies process as well exportation of human biological samples.
  • Supportive and experienced staff in the management of clinical supplies logistics chain;

 

Our best to your expectations

  • Qualified and experienced CRAs
  • Experienced Project Management
  • Project Team Chemistry
  • Responsiveness
  • Low Staff Turnover
  • Vast Therapeutic Expertise
  • Timely Project Communications
  • KOL and experienced sites networking

Customers and Partners

  • JCR
  • biomm
  • brooklyn
  • espeion
  • geistlich
  • irx
  • mypharm
  • onconova
  • pfizer
  • savant
  • terumo
  • uerj
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