About Us
···Services
- Regulatory Affairs
- Clinical Operations
- Data Management
- Biostatistics
- Medical Services
- Pharmacovigilance
- Quality Assurance
- Biotech Consultancy
- Patient Recruitment
We have participated in more than 100 projects and have processed over 3000 cases globally.
Over the last years, we have consolidated a broad experience in delivering accurate, high quality and on-time safety and pharmacovigilance services to our clients as part of a full service programme or a single source request. Below are some of our key milestones highlights.
Key quantitative metrics achieved during the past 5 years:
- # of SAEs processed: >3,000 cases
- # SUSARs submitted: >900 cases
- # Studies with delegated PVG: >120 projects
- # Countries covered to date: 26 (EU, US and Canada)
Selected examples:
| Sponsor | Phase | Description | Patients | Countries |
|---|---|---|---|---|
| US Co. | III | Preterm birth | 1,700 | 100 |
| European Co. | II | Pain / Colorectal cancer | 120 | 5 |
| European Co. | II | Renal cancer | 115 | 14 |
| European Co. | II/III | Bladder cancer | 372 | 45 |
| European Co. | II | Pancreatic cancer | 120 | 10 |
| European Co. | I/II | NSCLC | 260 | 30 | Us Co. | III | AML | 326 | 115 | Us Co. | II | AML | 76 | 24 | Us Co. | II | AML | 300 | 85 | Us Co. | II | MDS/CML | 158 | 25 | Us Co. | I/II | AML | 18-33 | 2-4 | Us Co. | III | GH deficiency | 84 | 56 |
