Clinical Research Operations:
- Quality Assessment of current operations
- Identification of “at risk processes”
- Recommended corrective actions
- Implementation of corrective actions
- Preparation of supporting Standard Operating Procedures and training programs
Electronic Data Capture/Direct Data Capture Implementation
- Project Management
- Establishment of User Requirements
- Preparation of Implementation Plan
- Operational assessment and recommendations for revision
to operational and clinical processes associated with implementation
of EDC/DDC
- Preparation of supporting Standard Operating Procedures
- Site validation
Site Operations
- Job Descriptions
- Staff Orientation
- Preparation of Study Budgets
- Standard Operating Procedures
- Implementation of formal training program
- Implementation of community based clinical research program
- Team meeting facilitation
Sponsor Services
- Process mapping
- Standard Operating Procedures
- Forms development
- Staff training
- Clinical sites planning to implement EDC
or DDC.
- Organizations planning to launch or expand current Clinical
Research Operations.
- Clinical Research sites with recent compliance audit
findings
- Clinical Research sites desiring to enhance quality while
realizing operating efficiencies.
- Newly established Clinical Research Sites.
- Newly established CRO’s
- Organizations desiring to revise current
SOPs.
- Newly merged organizations needing
to merge process and develop complimenting SOPs.
If you'd like to know more about the
services we offer and how they could apply to your organization,
please contact
us today! |
