Atlantis Clinical provides a large array of services, such as regulatory, monitoring, sites selection, training, regulatory agencies advisory, KOL networking, therapeutic expertise, safety, statistics, EDC for all kind of customers, being pharmaceutical, biotechnology industries, medical devices, vaccines, phytotherapy and cosmetics.
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
- Low Staff Turnover
- Vast Therapeutic Expertise
- Timely Project Communications
- KOL and experienced sites networking
- Trial Management
- Regulatory advisory
- Logistics expertise