Services
Clinical Operations Phase II-IV
Efficacy and safety
In all our offices, clinical operations teams offer a wide network of monitors, both locally and centralised, and can conduct and manage all or parts of your clinical studies from Phase II-IV, with regard to design, management, monitoring and reporting. All our studies are carried out to the standards of ICH-GCP and all procedures and data collected are audited and subjected to our in-house Quality Assurance. Our staffs all have medical/scientific backgrounds and undergo continual, documented training. Each CRA only monitors a limited number of studies and/or sites, to enable them to maintain the level of attention your project requires. Your project manager will offer you solutions rather than questions and will report back directly to you, ensuring project continuity and good relationships between CRAs, site personnel and the sponsor, whilst managing your study on time and within budget.
Our core competence includes:
- Study set-up, assistance with contract negotiations, investigator recruitment, pre-study qualification visits
- Protocol writing and review
- CRF/eCRF development and/or review
- Ensuring subject safety and regulatory compliance in IRB affairs
- Training study site teams in protocol and study management
- Performing initiation visit, monitoring visits and study close-out visit
- Managing study supplies and clinical site payments
- Expediting accurate, clean and supportable study data
- Ensuring complete collection and archiving of all regulatory and study data
- Ensuring audits and QA review carried out by QA unit
Our services vary according to your needs and we will always offer you a tailor made solution. All projects are supported by an HCR study physician, ensuring continuous review of safety, ethical and clinical aspects and quick response and turn-around of medical issues.
Feel free to phone us
...straight away and we will work out together a tailor made solution for you.
Tel: (49) - 89 - 126680-0