Regardless of whether our clients are running a small Phase I trial or many, complex Phase III trials we are always paying equal attention to ensure collection, management and processing of clinical data reliably, efficiently and in compliance with industry standards and government regulations.
Accelsiors has developed its own highly dedicated biometrics teams working in four well defined sub-units:
- Data Management
- Biostatistics
- PK/PD Analysis and
- Population Pharmacokinetics Modeling
Each sub-unit offers a wide range of services starting from customer specific stand-alone services to the implementation of end-to-end services and all our employees are committed to providing high quality deliverables within required timelines.
Irrespective of the data processing stage and biometrics sub-unit involvement we are always bearing in mind four key elements:
- Shortening the Cycle Times
- Improving Data Quality
- Improving Security and Confidentiality
- Improving Cost-Efficiency Through Reengineered Processes
Our SOPs and processes are framed by applicable regulatory requirements such as ICHGCP, FDA 21 CFR Part 11 and other customer specific standards.
We use and rely on well-known technologies and fully validated software such as:
- Oracle Clinical
- Oracle RDC
- Thesaurus Management System
- MedDRA
- WHO DD
- SAS
- WinNonlin
Our Biometrics Unit Team comprises dedicated professionals with experience and expertise across a broad spectrum of therapeutic areas. These professionals include engineers, programmers, physicians, LPNs, RNs, validation specialists, medical laboratory technologists, clinical-site coordinators, and technology experts.
