OUR WORK PACKAGES:
| Clinical Development Planning Literature Reviews |
Fully Integrated Clinical 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 |
