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.
ALCHEMY’s Site Management (SMO) services 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
A) Pre initiation
- Identification of Potential Sites
- Faster Feasibility
- Site set up, supplies and other infrastructure needs
- Regulatory and IEC/ IRB communications
- Rapid negotiation of CTA
- Setting up Standard Operating Procedures (SOPs)
B) During Study Duration
- Provide dedicated trained and experienced CRCs (Clinical research coordinators)
- Patient recruitment & retention Support
- Maintenance of essential documents
- Source documentation as per ALCOA standards (Attributable, Legible, Contemporaneous, Original & Accurate
- Regular IP (Investigational Product) accountability and storage
- Completion of CRF’s within timelines
- Faster query resolution
- Reporting of AE, SAEs within timelines
- Support Monitoring visits and Quality Assurance audit action items.
- Patient visit Follow Up and compliance assistance
- Preparation of site for monitoring and audits/ inspections
C) Post Close Out
- Site Close out activities
- Destruction of used IP’s
- Archiving of site results and documents
- SEC Notifications of Close out and CSR