Clinical Operations
Working diligently to improve efficiency for study design, start-up and managing clinical trials for successful completion
Our Clinical Operations team is comprised of highly skilled professionals who are experienced in managing clinical trials, covering broad range of therapeutic areas. The team comprise of well trained professionals who are readily available to meet project needs and drive project management, patient recruitment and retention, clinical monitoring and site management functions for your clinical trials. Our directive recognises the need for quality clinical services backed by experience, protocol adherence, ICH/GCP training, and cost advantages.
What We do
Interventional Trials
- Study Feasibility
- Site evaluation and selection
- Planning, budgeting and resourcing
- Trial master file Management
- Submission to Institutional Review Board (IRBs) and Regulatory Authorities
- Cloud based EDC
- Trial Initiation
- Patient recruitment and retention
- Trial monitoring
- Project management
- Safety reporting
- Archival of essential documents
- Site Closeout
Non Interventional Trials
- Study Feasibility
- Site evaluation and selection
- Identification/Recruitment of InvestigatorProject management
- Tracking study status
- Files preparation, contract negotiation and Submissions to Ethics Committee and Regulatory Authorities
- Set up and Maintenance of study files
- Safety reporting
- Completion of study as per agreed budget and timelines
- Archival of essential documents
Clinical data management
- Database design, development and maintenance
- Query management and data cleaning
- SAE reconciliation
- Case report form design
- Medical coding using
- MedDRA or WHODD Database validation and testing
- Creation of data management plan and associated documents
- Database lock and Archival
GET IN TOUCH NOW
For more information on our expert clinical operations services, call us at (410) 928-8187 to speak to one of our knowledgeable team.