| OUR EXPERTISE INCLUDES: | |
| Design of Clinical Development Plans |
Feasibility Studies and Site Assessments |
| IMP Management, including QP release |
Fully Integrated EDC systems (eCRF) |
| Project Management | Clinical Execution |
| Clinical Monitoring | Subject Recruitment |
| Quality Management Audits | Safety Management |
| Quality Management | Data Management |
| Biostatistics | Protocol Development |
| Laboratory Management | Pharmacovigilance |
| Medical Writing, including study synopsis and study protocol writing | Regulatory Contacts |
| WE HAVE CLEARLY DEFINED WORK PACKAGES: | |
| Clinical Development Planning – Literature Reviews |
Fully Integrated Study Reports and Statistical Analysis |
| Clinical Trial Consulting – CDPs, SOPs, Scientific Advice |
Quality Management – Audits |
| Protocol Writing – Including Statistical Design and Data Management Planning |
Regulatory Contracts – Submissions to Ethics Committees and Competent Authorities |
| Fully Integrated electronic Data Management – eCRF using InterTrial |
Pharmacovigilance – Safety Desk, coding (MedDRA, WHO-DD, ATC) |
| Fully Integrated Project Management – Study Coordination, Monitoring, Site Contacts, IMP Handling, Laboratory Services, import/export licenses |
Medical Writing – Investigator Brochures, IMPDs |