SITE MANAGEMENT services:
We provide our services to phase II-IV “Interventional and Observational Clinical trials include drugs, as well as biological products, medical devices, and surgical procedures. Our services Accelerate your Clinical development program provide a complete package of Site management solutions such as Site Feasibilities submission, Data management support till the Report generation.
Qualified study coordinators and site management associates are key to the successful management of a clinical trial.
CLINISYD Site Management (SMO) service provides highly qualified and experienced Study Coordinators (SCs) and Site Management Associates (SMAs) to help support both principal investigators and sponsors. Through our SMO service, we provide principal investigators with trained SCs to assist with daily clinical trial activity and patient recruitment and sponsors with experienced SMAs to provide clinical trial site management and ethics committee support
Services
- Start-up activities and Study Management
- Ethics Committee communication and management
- Site contract, budget, expense management GCP documents/training review
- Subject recruitment and retention management
- Vendor Management
Subject safety management - Ensuring Study compliance
- Data entry and management
- Site team Training and Recruitment
Source and TMF document generation and Maintenance - Site Management and Operation
- Monitoring and auditing support.
- Recruitment of CRA, CRC, Study Nurse, Phlebotomist
- Electronic Data Capture (EDC) and Data Management
- Quality control
- Regulatory submission support
