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Clinical trial management |
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Quartesian, in alliance with Clinical Research Management (CRM), can give our
clients the benefit of having experienced clinical research professionals including
accredited CRAs, well trained project managers, medical officers and GCP auditors
providing services such as:
- Study Monitoring, Project and Program Management
- Clinical Drug / Device Supply Management
- Study Site Evaluation and GCP/ICH Compliance Audits
- Study Site and Regulatory (GCP/ICH) Training
- IND Safety Report Tracking and Management
- Medical Safety Surveillance / Pharmacovigilance
- Study File Management and Scanning (preparation for eSubmissions)
CRM shares our philosophy of cost containment, flexibility and well managed project
teams. The majority of the CRAs have more than 7 years experience plus extensive
knowledge of their particular therapeutic area of specialization. Most of the project
managers are themselves experienced CRAs who have the real world experience that
is required to make a project successful. CRM’s medical officers have evaluated,
managed and reported the safety information for IND programs, NDAs/BLAs and
post-marketing surveillance. Detail-oriented GCP Auditors provide site auditing
services for study closeouts, NDA/BLA preparation, as well as pre-emptive audits for
cause.
In addition to the resources CRM offers, we have the ability to recruit investigators and place CRAs in Central and Eastern Europe (CEE) and in India. These parts of the world offer competent principal investigators and research staff, adequately equipped facilities and the necessary infrastructure to support the latest technologies for Web based trial
management. Thus we enhance our ability to monitor the progress of a trial, issue status reports and track data queries while containing costs.
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